Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06330311
Other study ID # 20/551-EC
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 29, 2024
Est. completion date September 29, 2024

Study information

Verified date April 2024
Source Universidad Complutense de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cerebral Palsy is the most common cause of severe physical disability in childhood and may present difficulties and limitations that will have an impact on their independence and integration in all social areas. Within interventions aiming to manage CP Whole-Body Vibration (WBV) has shown some benefits such as reducing spasticity or improving strength and functionality of the lower limbs. The aim of this study is to assess the effectiveness on motor function and spasticity of the lower limbs by adding an intervention with WBV to an evidence-based multimodal physiotherapy treatment in children with CP.


Description:

Cerebral Palsy is the most common cause of severe physical disability in childhood (1.5 - 3 cases per thousand live births) and may or may not be accompanied by intellectual, sensory, communication deficits and epileptic syndromes depending on the brain region affected. The most frequent form of presentation is spastic cerebral palsy, characterized by atypical motor development, abnormal movement or posture, hyperreflexia, and increased muscle tone. These difficulties and limitations will have an impact on their independence and integration in all social areas. The use of Whole-Body Vibration (WBV) to reduce spasticity of the lower limb and thereby improve functionality has been used for more than a decade showing some benefits such as reducing spasticity or improving strength and functionality of the lower limbs. The purpose of this randomized controlled trial is to assess the effectiveness on motor function and spasticity of the lower limbs by adding an intervention with WBV to an evidence-based multimodal physiotherapy treatment in children with CP.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date September 29, 2024
Est. primary completion date September 29, 2024
Accepts healthy volunteers No
Gender All
Age group 8 Years to 14 Years
Eligibility Inclusion Criteria: - Patients diagnosed with spastic cerebral palsy. - Aged between 8 and 14 years. - GMFCS I, II or III: with the ability to walk independently with or without technical aids; with the ability to stand for 3 minutes independently or gripped on the stand; with the ability to understand and follow simple instructions; with the ability to tolerate clinical tests and examinations. Exclusion Criteria: - Participation in treatments with serial casting or botulinum toxin during the 3 months prior to the study. - Recent orthopedic surgery (less than 12 months). - Participation in other muscle strengthening programs during the 4 months prior to this clinical study. - Children who have developed fixed contractures in lower limbs joints. - Medical conditions where physical exercise is contraindicated.

Study Design


Intervention

Other:
Physiotherapy
Evidence-based multimodal physiotherapy treatment based on learning and motor control

Locations

Country Name City State
Spain María José Díaz Arribas Madrid

Sponsors (2)

Lead Sponsor Collaborator
Universidad Complutense de Madrid Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (76)

Amirmudin NA, Lavelle G, Theologis T, Thompson N, Ryan JM. Multilevel Surgery for Children With Cerebral Palsy: A Meta-analysis. Pediatrics. 2019 Apr;143(4):e20183390. doi: 10.1542/peds.2018-3390. — View Citation

Badia M, Orgaz MB, Riquelme I, Gómez-Iruretagoyena J. Domains of the Cerebral Palsy Quality of Life Questionnaire (CP QOL) for Children and Adolescents: Spanish Adaptation and Psychometric Properties. 2021;33:331-349.

Bloemen M, Van Wely L, Mollema J, Dallmeijer A, de Groot J. Evidence for increasing physical activity in children with physical disabilities: a systematic review. Dev Med Child Neurol. 2017 Oct;59(10):1004-1010. doi: 10.1111/dmcn.13422. Epub 2017 Apr 4. — View Citation

Booth ATC, Buizer AI, Meyns P, Oude Lansink ILB, Steenbrink F, van der Krogt MM. The efficacy of functional gait training in children and young adults with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2018 Sep;60(9):866-883. doi: 10.1111/dmcn.13708. Epub 2018 Mar 7. — View Citation

Brandao MB, Mancini MC, Ferre CL, Figueiredo PRP, Oliveira RHS, Goncalves SC, Dias MCS, Gordon AM. Does Dosage Matter? A Pilot Study of Hand-Arm Bimanual Intensive Training (HABIT) Dose and Dosing Schedule in Children with Unilateral Cerebral Palsy. Phys Occup Ther Pediatr. 2018 Aug;38(3):227-242. doi: 10.1080/01942638.2017.1407014. Epub 2017 Dec 14. — View Citation

Buccino G, Arisi D, Gough P, Aprile D, Ferri C, Serotti L, Tiberti A, Fazzi E. Improving upper limb motor functions through action observation treatment: a pilot study in children with cerebral palsy. Dev Med Child Neurol. 2012 Sep;54(9):822-8. doi: 10.1111/j.1469-8749.2012.04334.x. Epub 2012 Jul 6. — View Citation

Buizer AI, Martens BHM, Grandbois van Ravenhorst C, Schoonmade LJ, Becher JG, Vermeulen RJ. Effect of continuous intrathecal baclofen therapy in children: a systematic review. Dev Med Child Neurol. 2019 Feb;61(2):128-134. doi: 10.1111/dmcn.14005. Epub 2018 Sep 6. — View Citation

Carey H, Martin K, Combs-Miller S, Heathcock JC. Reliability and Responsiveness of the Timed Up and Go Test in Children With Cerebral Palsy. Pediatr Phys Ther. 2016 winter;28(4):401-8. doi: 10.1097/PEP.0000000000000301. — View Citation

Chen YP, Pope S, Tyler D, Warren GL. Effectiveness of constraint-induced movement therapy on upper-extremity function in children with cerebral palsy: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2014 Oct;28(10):939-53. doi: 10.1177/0269215514544982. Epub 2014 Aug 14. — View Citation

Cheng HY, Ju YY, Chen CL, Chuang LL, Cheng CH. Effects of whole body vibration on spasticity and lower extremity function in children with cerebral palsy. Hum Mov Sci. 2015 Feb;39:65-72. doi: 10.1016/j.humov.2014.11.003. Epub 2014 Nov 24. — View Citation

Cheng HY, Yu YC, Wong AM, Tsai YS, Ju YY. Effects of an eight-week whole body vibration on lower extremity muscle tone and function in children with cerebral palsy. Res Dev Disabil. 2015 Mar;38:256-61. doi: 10.1016/j.ridd.2014.12.017. Epub 2015 Jan 7. — View Citation

Chiu HC, Ada L. Constraint-induced movement therapy improves upper limb activity and participation in hemiplegic cerebral palsy: a systematic review. J Physiother. 2016 Jul;62(3):130-7. doi: 10.1016/j.jphys.2016.05.013. Epub 2016 Jun 17. — View Citation

Chiu HC, Ada L. Effect of functional electrical stimulation on activity in children with cerebral palsy: a systematic review. Pediatr Phys Ther. 2014 Fall;26(3):283-8. doi: 10.1097/PEP.0000000000000045. — View Citation

Das SP, Ganesh GS. Evidence-based Approach to Physical Therapy in Cerebral Palsy. Indian J Orthop. 2019 Jan-Feb;53(1):20-34. doi: 10.4103/ortho.IJOrtho_241_17. — View Citation

Dewar R, Claus AP, Tucker K, Ware RS, Johnston LM. Reproducibility of the Kids-BESTest and the Kids-Mini-BESTest for Children With Cerebral Palsy. Arch Phys Med Rehabil. 2019 Apr;100(4):695-702. doi: 10.1016/j.apmr.2018.12.021. Epub 2019 Jan 9. — View Citation

Dodd KJ, Taylor NF, Graham HK. A randomized clinical trial of strength training in young people with cerebral palsy. Dev Med Child Neurol. 2003 Oct;45(10):652-7. doi: 10.1017/s0012162203001221. — View Citation

Engsberg JR, Ross SA, Collins DR. Increasing ankle strength to improve gait and function in children with cerebral palsy: a pilot study. Pediatr Phys Ther. 2006 Winter;18(4):266-75. doi: 10.1097/01.pep.0000233023.33383.2b. — View Citation

Ferre CL, Brandao M, Surana B, Dew AP, Moreau NG, Gordon AM. Caregiver-directed home-based intensive bimanual training in young children with unilateral spastic cerebral palsy: a randomized trial. Dev Med Child Neurol. 2017 May;59(5):497-504. doi: 10.1111/dmcn.13330. Epub 2016 Nov 19. — View Citation

Fonseca PRJ, Filoni E, Melo Setter C, Marques Berbel A, Olival Fernandes A, Calhes de Franco Moura R. Constraint-induced movement therapy of upper limb of children with cerebral palsy in clinical practice: systematic review of the literature. Fisioterapia e Pesquisa. 2017;24(3):334-46.

Friel KM, Kuo HC, Fuller J, Ferre CL, Brandao M, Carmel JB, Bleyenheuft Y, Gowatsky JL, Stanford AD, Rowny SB, Luber B, Bassi B, Murphy DL, Lisanby SH, Gordon AM. Skilled Bimanual Training Drives Motor Cortex Plasticity in Children With Unilateral Cerebral Palsy. Neurorehabil Neural Repair. 2016 Oct;30(9):834-44. doi: 10.1177/1545968315625838. Epub 2016 Feb 11. — View Citation

Gannotti ME. Coupling Timing of Interventions With Dose to Optimize Plasticity and Participation in Pediatric Neurologic Populations. Pediatr Phys Ther. 2017 Jul;29 Suppl 3(Suppl 3 IV STEP 2016 CONFERENCE PROCEEDINGS ):S37-S47. doi: 10.1097/PEP.0000000000000383. — View Citation

Gusso S, Munns CF, Colle P, Derraik JG, Biggs JB, Cutfield WS, Hofman PL. Effects of whole-body vibration training on physical function, bone and muscle mass in adolescents and young adults with cerebral palsy. Sci Rep. 2016 Mar 3;6:22518. doi: 10.1038/sr — View Citation

Ha SY, Sung YH. Effects of Vojta approach on diaphragm movement in children with spastic cerebral palsy. J Exerc Rehabil. 2018 Dec 27;14(6):1005-1009. doi: 10.12965/jer.1836498.249. eCollection 2018 Dec. — View Citation

Hadders-Algra M, Boxum AG, Hielkema T, Hamer EG. Effect of early intervention in infants at very high risk of cerebral palsy: a systematic review. Dev Med Child Neurol. 2017 Mar;59(3):246-258. doi: 10.1111/dmcn.13331. Epub 2016 Dec 7. — View Citation

Hagglund G, Alriksson-Schmidt A, Lauge-Pedersen H, Rodby-Bousquet E, Wagner P, Westbom L. Prevention of dislocation of the hip in children with cerebral palsy: 20-year results of a population-based prevention programme. Bone Joint J. 2014 Nov;96-B(11):1546-52. doi: 10.1302/0301-620X.96B11.34385. — View Citation

Hasnat MJ, Rice JE. Intrathecal baclofen for treating spasticity in children with cerebral palsy. Cochrane Database Syst Rev. 2015 Nov 13;2015(11):CD004552. doi: 10.1002/14651858.CD004552.pub2. — View Citation

Health Quality Ontario. Lumbosacral Dorsal Rhizotomy for Spastic Cerebral Palsy: A Health Technology Assessment. Ont Health Technol Assess Ser. 2017 Jul 6;17(10):1-186. eCollection 2017. — View Citation

Hoare BJ, Wallen MA, Thorley MN, Jackman ML, Carey LM, Imms C. Constraint-induced movement therapy in children with unilateral cerebral palsy. Cochrane Database Syst Rev. 2019 Apr 1;4(4):CD004149. doi: 10.1002/14651858.CD004149.pub3. — View Citation

Huang M, Liao LR, Pang MY. Effects of whole body vibration on muscle spasticity for people with central nervous system disorders: a systematic review. Clin Rehabil. 2017 Jan;31(1):23-33. doi: 10.1177/0269215515621117. Epub 2016 Jul 11. — View Citation

Inguaggiato E, Sgandurra G, Perazza S, Guzzetta A, Cioni G. Brain reorganization following intervention in children with congenital hemiplegia: a systematic review. Neural Plast. 2013;2013:356275. doi: 10.1155/2013/356275. Epub 2013 Dec 3. — View Citation

Jamali AR, Amini M. The Effects of Constraint-Induced Movement Therapy on Functions of Cerebral Palsy Children. Iran J Child Neurol. 2018 Fall;12(4):16-27. — View Citation

Kahraman A, Seyhan K, Deger U, Kutluturk S, Mutlu A. Should botulinum toxin A injections be repeated in children with cerebral palsy? A systematic review. Dev Med Child Neurol. 2016 Sep;58(9):910-7. doi: 10.1111/dmcn.13135. Epub 2016 Apr 22. — View Citation

Katusic A, Alimovic S, Mejaski-Bosnjak V. The effect of vibration therapy on spasticity and motor function in children with cerebral palsy: a randomized controlled trial. NeuroRehabilitation. 2013;32(1):1-8. doi: 10.3233/NRE-130817. — View Citation

Katz-Leurer M, Rottem H, Meyer S. Hand-held dynamometry in children with traumatic brain injury: within-session reliability. Pediatr Phys Ther. 2008 Fall;20(3):259-63. doi: 10.1097/PEP.0b013e3181824782. — View Citation

Kleim JA, Jones TA. Principles of experience-dependent neural plasticity: implications for rehabilitation after brain damage. J Speech Lang Hear Res. 2008 Feb;51(1):S225-39. doi: 10.1044/1092-4388(2008/018). — View Citation

Ko J, Kim M. Reliability and responsiveness of the gross motor function measure-88 in children with cerebral palsy. Phys Ther. 2013 Mar;93(3):393-400. doi: 10.2522/ptj.20110374. Epub 2012 Nov 8. — View Citation

Kruijsen-Terpstra AJA, Ketelaar M, Verschuren O, Gorter JW, Vos RC, Verheijden J, Jongmans MJ, Visser-Meily A. Efficacy of three therapy approaches in preschool children with cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2016 Jul;58(7):758-766. doi: 10.1111/dmcn.12966. Epub 2015 Nov 24. — View Citation

Lamberts RP, Burger M, du Toit J, Langerak NG. A Systematic Review of the Effects of Single-Event Multilevel Surgery on Gait Parameters in Children with Spastic Cerebral Palsy. PLoS One. 2016 Oct 18;11(10):e0164686. doi: 10.1371/journal.pone.0164686. eCollection 2016. — View Citation

Lefmann S, Russo R, Hillier S. The effectiveness of robotic-assisted gait training for paediatric gait disorders: systematic review. J Neuroeng Rehabil. 2017 Jan 5;14(1):1. doi: 10.1186/s12984-016-0214-x. — View Citation

Maher CA, Williams MT, Olds TS. The six-minute walk test for children with cerebral palsy. Int J Rehabil Res. 2008 Jun;31(2):185-8. doi: 10.1097/MRR.0b013e32830150f9. — View Citation

Martins E, Cordovil R, Oliveira R, Letras S, Lourenco S, Pereira I, Ferro A, Lopes I, Silva CR, Marques M. Efficacy of suit therapy on functioning in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2016 Apr;58(4):348-60. doi: 10.1111/dmcn.12988. Epub 2015 Nov 27. — View Citation

McIntyre S, Goldsmith S, Webb A, Ehlinger V, Hollung SJ, McConnell K, Arnaud C, Smithers-Sheedy H, Oskoui M, Khandaker G, Himmelmann K; Global CP Prevalence Group*. Global prevalence of cerebral palsy: A systematic analysis. Dev Med Child Neurol. 2022 Dec;64(12):1494-1506. doi: 10.1111/dmcn.15346. Epub 2022 Aug 11. — View Citation

Mockford M, Caulton JM. Systematic review of progressive strength training in children and adolescents with cerebral palsy who are ambulatory. Pediatr Phys Ther. 2008 Winter;20(4):318-33. doi: 10.1097/PEP.0b013e31818b7ccd. — View Citation

Moreau NG, Bodkin AW, Bjornson K, Hobbs A, Soileau M, Lahasky K. Effectiveness of Rehabilitation Interventions to Improve Gait Speed in Children With Cerebral Palsy: Systematic Review and Meta-analysis. Phys Ther. 2016 Dec;96(12):1938-1954. doi: 10.2522/ptj.20150401. Epub 2016 Jun 16. — View Citation

Morgan C, Darrah J, Gordon AM, Harbourne R, Spittle A, Johnson R, Fetters L. Effectiveness of motor interventions in infants with cerebral palsy: a systematic review. Dev Med Child Neurol. 2016 Sep;58(9):900-9. doi: 10.1111/dmcn.13105. Epub 2016 Mar 29. — View Citation

Morgan C, Novak I, Badawi N. Enriched environments and motor outcomes in cerebral palsy: systematic review and meta-analysis. Pediatrics. 2013 Sep;132(3):e735-46. doi: 10.1542/peds.2012-3985. Epub 2013 Aug 19. — View Citation

Multani I, Manji J, Hastings-Ison T, Khot A, Graham K. Botulinum Toxin in the Management of Children with Cerebral Palsy. Paediatr Drugs. 2019 Aug;21(4):261-281. doi: 10.1007/s40272-019-00344-8. — View Citation

Mutlu A, Livanelioglu A, Gunel MK. Reliability of Ashworth and Modified Ashworth scales in children with spastic cerebral palsy. BMC Musculoskelet Disord. 2008 Apr 10;9:44. doi: 10.1186/1471-2474-9-44. — View Citation

Novak I, Berry J. Home program intervention effectiveness evidence. Phys Occup Ther Pediatr. 2014 Nov;34(4):384-9. doi: 10.3109/01942638.2014.964020. Epub 2014 Oct 15. No abstract available. — View Citation

Novak I, Hines M, Goldsmith S, Barclay R. Clinical prognostic messages from a systematic review on cerebral palsy. Pediatrics. 2012 Nov;130(5):e1285-312. doi: 10.1542/peds.2012-0924. Epub 2012 Oct 8. — View Citation

Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21. — View Citation

Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Re — View Citation

Nsenga Leunkeu A, Shephard RJ, Ahmaidi S. Six-minute walk test in children with cerebral palsy gross motor function classification system levels I and II: reproducibility, validity, and training effects. Arch Phys Med Rehabil. 2012 Dec;93(12):2333-9. doi: 10.1016/j.apmr.2012.06.005. Epub 2012 Jun 18. — View Citation

O'Brien TD, Noyes J, Spencer LH, Kubis HP, Hastings RP, Whitaker R. Systematic review of physical activity and exercise interventions to improve health, fitness and well-being of children and young people who use wheelchairs. BMJ Open Sport Exerc Med. 2016 Nov 15;2(1):e000109. doi: 10.1136/bmjsem-2016-000109. eCollection 2016. — View Citation

Pandey, D. P., & Tyagi, V. (2011). Effect of functional strength training on functional motor performance in young children with cerebral palsy. Indian Journal of Physiotherapy and Occupational Therapy, 5(1), 52-55.

Pandyan AD, Gregoric M, Barnes MP, Wood D, Van Wijck F, Burridge J, Hermens H, Johnson GR. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil. 2005 Jan 7-21;27(1-2):2-6. doi: 10.1080/09638280400014576. No abstract available. — View Citation

Park EY, Kim WH. Meta-analysis of the effect of strengthening interventions in individuals with cerebral palsy. Res Dev Disabil. 2014 Feb;35(2):239-49. doi: 10.1016/j.ridd.2013.10.021. Epub 2013 Nov 27. — View Citation

Peungsuwan P, Parasin P, Siritaratiwat W, Prasertnu J, Yamauchi J. Effects of Combined Exercise Training on Functional Performance in Children With Cerebral Palsy: A Randomized-Controlled Study. Pediatr Phys Ther. 2017 Jan;29(1):39-46. doi: 10.1097/PEP.00 — View Citation

Pin TW, Butler PB, Purves S. Use of whole body vibration therapy in individuals with moderate severity of cerebral palsy- a feasibility study. BMC Neurol. 2019 May 1;19(1):80. doi: 10.1186/s12883-019-1307-5. — View Citation

Reedman S, Boyd RN, Sakzewski L. The efficacy of interventions to increase physical activity participation of children with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2017 Oct;59(10):1011-1018. doi: 10.1111/dmcn.13413. Epub 2017 Mar 20. — View Citation

Ritzmann R, Stark C, Krause A. Vibration therapy in patients with cerebral palsy: a systematic review. Neuropsychiatr Dis Treat. 2018 Jun 18;14:1607-1625. doi: 10.2147/NDT.S152543. eCollection 2018. — View Citation

Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480. — View Citation

Ross SA, Engsberg JR. Relationships between spasticity, strength, gait, and the GMFM-66 in persons with spastic diplegia cerebral palsy. Arch Phys Med Rehabil. 2007 Sep;88(9):1114-20. doi: 10.1016/j.apmr.2007.06.011. — View Citation

Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020. — View Citation

Sakzewski L, Ziviani J, Boyd RN. Efficacy of upper limb therapies for unilateral cerebral palsy: a meta-analysis. Pediatrics. 2014 Jan;133(1):e175-204. doi: 10.1542/peds.2013-0675. Epub 2013 Dec 23. — View Citation

Salazar AP, Pagnussat AS, Pereira GA, Scopel G, Lukrafka JL. Neuromuscular electrical stimulation to improve gross motor function in children with cerebral palsy: a meta-analysis. Braz J Phys Ther. 2019 Sep-Oct;23(5):378-386. doi: 10.1016/j.bjpt.2019.01.006. Epub 2019 Jan 23. — View Citation

Salem Y, Godwin EM. Effects of task-oriented training on mobility function in children with cerebral palsy. NeuroRehabilitation. 2009;24(4):307-13. doi: 10.3233/NRE-2009-0483. — View Citation

Saquetto M, Carvalho V, Silva C, Conceicao C, Gomes-Neto M. The effects of whole body vibration on mobility and balance in children with cerebral palsy: a systematic review with meta-analysis. J Musculoskelet Neuronal Interact. 2015 Jun;15(2):137-44. — View Citation

Sgandurra G, Ferrari A, Cossu G, Guzzetta A, Fogassi L, Cioni G. Randomized trial of observation and execution of upper extremity actions versus action alone in children with unilateral cerebral palsy. Neurorehabil Neural Repair. 2013 Nov-Dec;27(9):808-15. doi: 10.1177/1545968313497101. Epub 2013 Jul 25. — View Citation

Taylor NF, Dodd KJ, Graham HK. Test-retest reliability of hand-held dynamometric strength testing in young people with cerebral palsy. Arch Phys Med Rehabil. 2004 Jan;85(1):77-80. doi: 10.1016/s0003-9993(03)00379-4. — View Citation

Tekin F, Kavlak E, Cavlak U, Altug F. Effectiveness of Neuro-Developmental Treatment (Bobath Concept) on postural control and balance in Cerebral Palsied children. J Back Musculoskelet Rehabil. 2018;31(2):397-403. doi: 10.3233/BMR-170813. — View Citation

Tinderholt Myrhaug H, Ostensjo S, Larun L, Odgaard-Jensen J, Jahnsen R. Intensive training of motor function and functional skills among young children with cerebral palsy: a systematic review and meta-analysis. BMC Pediatr. 2014 Dec 5;14:292. doi: 10.118 — View Citation

Toovey R, Bernie C, Harvey AR, McGinley JL, Spittle AJ. Task-specific gross motor skills training for ambulant school-aged children with cerebral palsy: a systematic review. BMJ Paediatr Open. 2017 Aug 11;1(1):e000078. doi: 10.1136/bmjpo-2017-000078. eCollection 2017. — View Citation

van Vulpen LF, de Groot S, Rameckers EAA, Becher JG, Dallmeijer AJ. Effectiveness of Functional Power Training on Walking Ability in Young Children With Cerebral Palsy: Study Protocol of a Double-Baseline Trial. Pediatr Phys Ther. 2017 Jul;29(3):275-282. doi: 10.1097/PEP.0000000000000424. — View Citation

Verschuren O, Darrah J, Novak I, Ketelaar M, Wiart L. Health-enhancing physical activity in children with cerebral palsy: more of the same is not enough. Phys Ther. 2014 Feb;94(2):297-305. doi: 10.2522/ptj.20130214. Epub 2013 Oct 3. — View Citation

Wells H, Marquez J, Wakely L. Garment Therapy does not Improve Function in Children with Cerebral Palsy: A Systematic Review. Phys Occup Ther Pediatr. 2018 Nov;38(4):395-416. doi: 10.1080/01942638.2017.1365323. Epub 2017 Sep 18. — View Citation

* Note: There are 76 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) GROSS MOTOR FUNCTION MEASURE 88 is a clinical test to evaluate changes in gross motor function over time in children and youth with cerebral palsy.
The GROSS MOTOR FUNCTION MEASURE 88 is divided in 5 dimensions:
A: Lying and rolling.
The minimum value is 0 and the maximum value is 51. Higher scores mean better outcome.
B: Sitting.
The minimum value is 0 and the maximum value is 60. Higher scores mean better outcome.
C: Crawling and Kneeling.
The minimum value is 0 and the maximum value is 42. Higher scores mean better outcome.
D: Standing.
The minimum value is 0 and the maximum value is 39. Higher scores mean better outcome.
E: Walking, running and jumping.
The minimum value is 0 and the maximum value is 72. Higher scores mean better outcome.
The minimum value overall of the GROSS MOTOR FUNCTION MEASURE 88 is 0 and the maximum value overall is 264. Higher scores mean better outcome.
Baseline
Primary GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) GROSS MOTOR FUNCTION MEASURE 88 is a clinical test to evaluate changes in gross motor function over time in children and youth with cerebral palsy.
The GROSS MOTOR FUNCTION MEASURE 88 is divided in 5 dimensions:
A: Lying and rolling.
The minimum value is 0 and the maximum value is 51. Higher scores mean better outcome.
B: Sitting.
The minimum value is 0 and the maximum value is 60. Higher scores mean better outcome.
C: Crawling and Kneeling.
The minimum value is 0 and the maximum value is 42. Higher scores mean better outcome.
D: Standing.
The minimum value is 0 and the maximum value is 39. Higher scores mean better outcome.
E: Walking, running and jumping.
The minimum value is 0 and the maximum value is 72. Higher scores mean better outcome.
The minimum value overall of the GROSS MOTOR FUNCTION MEASURE 88 is 0 and the maximum value overall is 264. Higher scores mean better outcome.
1 month
Primary GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) GROSS MOTOR FUNCTION MEASURE 88 is a clinical test to evaluate changes in gross motor function over time in children and youth with cerebral palsy.
The GROSS MOTOR FUNCTION MEASURE 88 is divided in 5 dimensions:
A: Lying and rolling.
The minimum value is 0 and the maximum value is 51. Higher scores mean better outcome.
B: Sitting.
The minimum value is 0 and the maximum value is 60. Higher scores mean better outcome.
C: Crawling and Kneeling.
The minimum value is 0 and the maximum value is 42. Higher scores mean better outcome.
D: Standing.
The minimum value is 0 and the maximum value is 39. Higher scores mean better outcome.
E: Walking, running and jumping.
The minimum value is 0 and the maximum value is 72. Higher scores mean better outcome.
The minimum value overall of the GROSS MOTOR FUNCTION MEASURE 88 is 0 and the maximum value overall is 264. Higher scores mean better outcome.
2 months
Primary GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) GROSS MOTOR FUNCTION MEASURE 88 is a clinical test to evaluate changes in gross motor function over time in children and youth with cerebral palsy.
The GROSS MOTOR FUNCTION MEASURE 88 is divided in 5 dimensions:
A: Lying and rolling.
The minimum value is 0 and the maximum value is 51. Higher scores mean better outcome.
B: Sitting.
The minimum value is 0 and the maximum value is 60. Higher scores mean better outcome.
C: Crawling and Kneeling.
The minimum value is 0 and the maximum value is 42. Higher scores mean better outcome.
D: Standing.
The minimum value is 0 and the maximum value is 39. Higher scores mean better outcome.
E: Walking, running and jumping.
The minimum value is 0 and the maximum value is 72. Higher scores mean better outcome.
The minimum value overall of the GROSS MOTOR FUNCTION MEASURE 88 is 0 and the maximum value overall is 264. Higher scores mean better outcome.
6 months
Primary Modified Ashworth Scale (MAS) The Modified Ashworth Scale is a clinical tool to measure the increase of muscle tone.
MAS is a 6 point numerical scale that graded muscle tone from 0 to 4:
0 = No increase in muscle tone
1 = Slight increase in muscle tone. Minimal resistance at end of range of motion
1+ = Slight increase in muscle tone. Minimal resistance through less than half of range of motion
2 = More marked increase in muscle tone through most range of motion. Affected part easily moved
3 = Considerable increase in muscle tone. Passive movement difficult
4 = Affected part rigid in flexion or extension
Baseline
Primary Modified Ashworth Scale (MAS) The Modified Ashworth Scale is a clinical tool to measure the increase of muscle tone.
MAS is a 6 point numerical scale that graded muscle tone from 0 to 4:
0 = No increase in muscle tone
1 = Slight increase in muscle tone. Minimal resistance at end of range of motion
1+ = Slight increase in muscle tone. Minimal resistance through less than half of range of motion
2 = More marked increase in muscle tone through most range of motion. Affected part easily moved
3 = Considerable increase in muscle tone. Passive movement difficult
4 = Affected part rigid in flexion or extension
1 month
Primary Modified Ashworth Scale (MAS) The Modified Ashworth Scale is a clinical tool to measure the increase of muscle tone.
MAS is a 6 point numerical scale that graded muscle tone from 0 to 4:
0 = No increase in muscle tone
1 = Slight increase in muscle tone. Minimal resistance at end of range of motion
1+ = Slight increase in muscle tone. Minimal resistance through less than half of range of motion
2 = More marked increase in muscle tone through most range of motion. Affected part easily moved
3 = Considerable increase in muscle tone. Passive movement difficult
4 = Affected part rigid in flexion or extension
2 month
Primary Modified Ashworth Scale (MAS) The Modified Ashworth Scale is a clinical tool to measure the increase of muscle tone.
MAS is a 6 point numerical scale that graded muscle tone from 0 to 4:
0 = No increase in muscle tone
1 = Slight increase in muscle tone. Minimal resistance at end of range of motion
1+ = Slight increase in muscle tone. Minimal resistance through less than half of range of motion
2 = More marked increase in muscle tone through most range of motion. Affected part easily moved
3 = Considerable increase in muscle tone. Passive movement difficult
4 = Affected part rigid in flexion or extension
6 month
Secondary 6 Minute Walking Test (6MWT) 6MWT is a test that measures the maximum distance walked by each patient for 6 minutes, on a hard and flat 30 meters surface.
The 6MWT assesses submaximal functional capacity. In addition to distance, the test measures oxygen saturation and heart rate.
Baseline
Secondary 6 Minute Walking Test (6MWT) 6MWT is a test that measures the maximum distance walked by each patient for 6 minutes, on a hard and flat 30 meters surface.
The 6MWT assesses submaximal functional capacity. In addition to distance, the test measures oxygen saturation and heart rate.
1 month
Secondary 6 Minute Walking Test (6MWT) 6MWT is a test that measures the maximum distance walked by each patient for 6 minutes, on a hard and flat 30 meters surface.
The 6MWT assesses submaximal functional capacity. In addition to distance, the test measures oxygen saturation and heart rate.
2 month
Secondary 6 Minute Walking Test (6MWT) 6MWT is a test that measures the maximum distance walked by each patient for 6 minutes, on a hard and flat 30 meters surface.
The 6MWT assesses submaximal functional capacity. In addition to distance, the test measures oxygen saturation and heart rate.
6 month
Secondary Dynamometry Hand dynamometer will be used to measure the strength in these muscles of the lower limbs:
Ankle dorsal flexion
Ankle plantar flexion
Hip flexors
Hip extensors
Knee flexors
Knee extensors
Hip abductors
Baseline
Secondary Dynamometry Hand dynamometer will be used to measure the strength in these muscles of the lower limbs:
Ankle dorsal flexion
Ankle plantar flexion
Hip flexors
Hip extensors
Knee flexors
Knee extensors
Hip abductors
1 month
Secondary Dynamometry Hand dynamometer will be used to measure the strength in these muscles of the lower limbs:
Ankle dorsal flexion
Ankle plantar flexion
Hip flexors
Hip extensors
Knee flexors
Knee extensors
Hip abductors
2 month
Secondary Dynamometry Hand dynamometer will be used to measure the strength in these muscles of the lower limbs:
Ankle dorsal flexion
Ankle plantar flexion
Hip flexors
Hip extensors
Knee flexors
Knee extensors
Hip abductors
6 month
Secondary Mini-Balance Evaluation System Test The Mini-Balance Evaluation System Test is a balance assessment that includes 14 items in 4 categories. The 14 items are scored from 0 to 2.
- Anticipatory
The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.
- Reactive Postural Control
The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.
- Sensory Orientation
The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.
- Dynamic Gait
The minimum value is 0 and the maximum value is 10. Higher scores mean better outcome.
The minimum value overall of the Mini-Balance Evaluation System is 0 and the maximum value overall is 28. Higher scores mean better outcome.
Baseline
Secondary Mini-Balance Evaluation System Test The Mini-Balance Evaluation System Test is a balance assessment that includes 14 items in 4 categories. The 14 items are scored from 0 to 2.
- Anticipatory
The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.
- Reactive Postural Control
The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.
- Sensory Orientation
The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.
- Dynamic Gait
The minimum value is 0 and the maximum value is 10. Higher scores mean better outcome.
The minimum value overall of the Mini-Balance Evaluation System is 0 and the maximum value overall is 28. Higher scores mean better outcome.
1 month
Secondary Mini-Balance Evaluation System Test The Mini-Balance Evaluation System Test is a balance assessment that includes 14 items in 4 categories. The 14 items are scored from 0 to 2.
- Anticipatory
The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.
- Reactive Postural Control
The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.
- Sensory Orientation
The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.
- Dynamic Gait
The minimum value is 0 and the maximum value is 10. Higher scores mean better outcome.
The minimum value overall of the Mini-Balance Evaluation System is 0 and the maximum value overall is 28. Higher scores mean better outcome.
2 month
Secondary Mini-Balance Evaluation System Test The Mini-Balance Evaluation System Test is a balance assessment that includes 14 items in 4 categories. The 14 items are scored from 0 to 2.
- Anticipatory
The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.
- Reactive Postural Control
The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.
- Sensory Orientation
The minimum value is 0 and the maximum value is 6. Higher scores mean better outcome.
- Dynamic Gait
The minimum value is 0 and the maximum value is 10. Higher scores mean better outcome.
The minimum value overall of the Mini-Balance Evaluation System is 0 and the maximum value overall is 28. Higher scores mean better outcome.
6 month
Secondary Cerebral Palsy Quality of Life questionnaire (CP-QOL) The Cerebral Palsy Quality of Life questionnaire will be used to assess several aspects of subjective happiness and well-being of children with cerebral palsy.
It sets up a profile of qualify of life of children with CP and understand their perception of life.
There are two versions of the CP-QOL:
- A primary caregiver-proxy report version.
The minimum value overall of the Cerebral Palsy Quality of Life questionnaire primary caregiver-proxy report version is 53 and the maximum value overall is 477. Higher scores mean better outcome.
- A self-report version for children with CP
The minimum value overall of the Cerebral Palsy Quality of Life questionnaire self-report version for children with CP is 43 and the maximum value overall is 387. Higher scores mean better outcome.
Baseline
Secondary Cerebral Palsy Quality of Life questionnaire (CP-QOL) The Cerebral Palsy Quality of Life questionnaire will be used to assess several aspects of subjective happiness and well-being of children with cerebral palsy.
It sets up a profile of qualify of life of children with CP and understand their perception of life.
There are two versions of the CP-QOL:
- A primary caregiver-proxy report version.
The minimum value overall of the Cerebral Palsy Quality of Life questionnaire primary caregiver-proxy report version is 53 and the maximum value overall is 477. Higher scores mean better outcome.
- A self-report version for children with CP
The minimum value overall of the Cerebral Palsy Quality of Life questionnaire self-report version for children with CP is 43 and the maximum value overall is 387. Higher scores mean better outcome.
2 month
Secondary Cerebral Palsy Quality of Life questionnaire (CP-QOL) The Cerebral Palsy Quality of Life questionnaire will be used to assess several aspects of subjective happiness and well-being of children with cerebral palsy.
It sets up a profile of qualify of life of children with CP and understand their perception of life.
There are two versions of the CP-QOL:
- A primary caregiver-proxy report version.
The minimum value overall of the Cerebral Palsy Quality of Life questionnaire primary caregiver-proxy report version is 53 and the maximum value overall is 477. Higher scores mean better outcome.
- A self-report version for children with CP
The minimum value overall of the Cerebral Palsy Quality of Life questionnaire self-report version for children with CP is 43 and the maximum value overall is 387. Higher scores mean better outcome.
6 month
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT02907775 - Multi-channel Stimulation for Post Stroke Spasticity (MUSTS) N/A
Recruiting NCT04530955 - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS) N/A
Active, not recruiting NCT03521076 - Randomized Controlled Trial of Virtual Reality N/A
Completed NCT03080454 - The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke Phase 1/Phase 2
Completed NCT02546999 - Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy? Phase 4
Active, not recruiting NCT01041157 - Botulinum Toxin Injection Efficiency Phase 1
Terminated NCT00531466 - Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury Phase 2
Terminated NCT00532532 - Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis Phase 2
Completed NCT00535938 - MDs on Botox Utility (MOBILITY) N/A
Completed NCT05546190 - A Study to Collect Participants Experience of Living With Adult Upper Limb (AUL) Spasticity and to Assess the Arm Activity Measure (ArmA)
Recruiting NCT06117020 - Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals Phase 1
Completed NCT01603628 - BOTOX® Treatment in Pediatric Lower Limb Spasticity Phase 3
Completed NCT05510726 - Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity
Not yet recruiting NCT04378946 - Error Augmentation Motor Learning Training Approach in Stroke Patients N/A
Completed NCT01603615 - BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity Phase 3
Completed NCT01251380 - Dysport® Pediatric Lower Limb Spasticity Follow-on Study Phase 3
Completed NCT00549783 - BOTOX® Economic Spasticity Trial (BEST) Phase 4
Completed NCT00210431 - Post Marketing Surveillance Study of Dysport
Completed NCT00076687 - Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function Phase 2