Effects of TOT on Walking in Children With CP

Cerebral Palsy Clinical Trial

Official title:

Effects of Task Oriented Training on Walking in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04561349
• Other study ID #: REC/00242 Madiha Tariq
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: September 2020
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study was to determine the effects of task oriented training (TOT) on walking and balance in children with spastic Cerebral Palsy (CP).

Description:

The aim of study is to evaluate the effectiveness of task-oriented training on the walking in Cerebral Palsy children and compare its results with that of the conservative rehabilitation treatment. By training children to walk using task oriented training not only improves their walk and balance but also encourage them to actively participate in their own treatment process. Task oriented training approach can prove to be an effective technique for those CP children who can perform ambulation and have defined targets for gross motor activities

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 30, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

Inclusion Criteria:

• Spastic CP children of age between 4 to 14 years

• With spasticity 2 or less on Modified Ashworth scale

• Who can walk (GMFCS level 1-3) and can

• Can perform different activities on command

Exclusion Criteria:

• Children with cognitive impairment

• Lower limb surgery in last 6 months

• Tetraplegic CP and who are unable to walk and follow command

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Task oriented training
Task oriented training consisted of different functional tasks for lower limbs to improve balance and walk. Each task was given 5 minutes Tasks were progressed according to each child's performance. These progressions included increase of repetitions, speed and switching between the tasks. One hour practice of these tasks was advised for home plan
• Conventional rehabilitation treatment
Conventional rehabilitation treatment includes mat activities and ROM of all limbs, Lower limb strengthening and stretching, walking, cycling. Each exercise was performed for 5 minutes. One hour practice of above exercises and thermotherapy for the spastic muscles advised for 10 minutes once a day at home was advised.

Locations

Country	Name	City	State
Pakistan	Armed Forces Institute of Rehabilitation Medicine (AFIRM)	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (22)

Borggraefe I, Schaefer JS, Klaiber M, Dabrowski E, Ammann-Reiffer C, Knecht B, Berweck S, Heinen F, Meyer-Heim A. Robotic-assisted treadmill therapy improves walking and standing performance in children and adolescents with cerebral palsy. Eur J Paediatr Neurol. 2010 Nov;14(6):496-502. doi: 10.1016/j.ejpn.2010.01.002. Epub 2010 Feb 6. — View Citation

Boyd RN, Jordan R, Pareezer L, Moodie A, Finn C, Luther B, Arnfield E, Pym A, Craven A, Beall P, Weir K, Kentish M, Wynter M, Ware R, Fahey M, Rawicki B, McKinlay L, Guzzetta A. Australian Cerebral Palsy Child Study: protocol of a prospective population based study of motor and brain development of preschool aged children with cerebral palsy. BMC Neurol. 2013 Jun 11;13:57. doi: 10.1186/1471-2377-13-57. — View Citation

Brown, G.T. and S.A. Burns, The efficacy of neurodevelopmental treatment in paediatrics: a systematic review. British Journal of occupational therapy, 2001. 64(5): p. 235-244.

Bumin G, Kayihan H. Effectiveness of two different sensory-integration programmes for children with spastic diplegic cerebral palsy. Disabil Rehabil. 2001 Jun 15;23(9):394-9. — View Citation

Granild-Jensen JB, Rackauskaite G, Flachs EM, Uldall P. Predictors for early diagnosis of cerebral palsy from national registry data. Dev Med Child Neurol. 2015 Oct;57(10):931-5. doi: 10.1111/dmcn.12760. Epub 2015 Apr 9. — View Citation

Ketelaar M, Vermeer A, Hart H, van Petegem-van Beek E, Helders PJ. Effects of a functional therapy program on motor abilities of children with cerebral palsy. Phys Ther. 2001 Sep;81(9):1534-45. — View Citation

Kim, J.-H. and Y.-E. Choi, The Effect of Task-oriented Training on Mobility Function, Postural Stability in Children with Cerebral Palsy. Korean Society of Physical Medicine, 2017. 12(3): p. 79-84.

Krigger KW. Cerebral palsy: an overview. Am Fam Physician. 2006 Jan 1;73(1):91-100. Review. — View Citation

Lim H, Kim T. Effects of vojta therapy on gait of children with spastic diplegia. J Phys Ther Sci. 2013 Dec;25(12):1605-8. doi: 10.1589/jpts.25.1605. Epub 2014 Jan 8. — View Citation

McGibbon NH, Andrade CK, Widener G, Cintas HL. Effect of an equine-movement therapy program on gait, energy expenditure, and motor function in children with spastic cerebral palsy: a pilot study. Dev Med Child Neurol. 1998 Nov;40(11):754-62. — 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. Review. — View Citation

Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689. Review. Erratum in: JAMA Pediatr. 2017 Sep 1;171(9):919. — View Citation

Paneth N. Establishing the diagnosis of cerebral palsy. Clin Obstet Gynecol. 2008 Dec;51(4):742-8. doi: 10.1097/GRF.0b013e318187081a. Review. — View Citation

Pavone, V. and G. Testa, Classification of cerebral Palsy. Orthopedic Management of Children with Cerebral Palsy. A Comprehensive Approach, eds F. Canavese, and J. Deslandes (New York, NY: NOVA), 2015: p. 75-98.

Reid LB, Rose SE, Boyd RN. Rehabilitation and neuroplasticity in children with unilateral cerebral palsy. Nat Rev Neurol. 2015 Jul;11(7):390-400. doi: 10.1038/nrneurol.2015.97. Epub 2015 Jun 16. Review. — View Citation

Rensink M, Schuurmans M, Lindeman E, Hafsteinsdóttir T. Task-oriented training in rehabilitation after stroke: systematic review. J Adv Nurs. 2009 Apr;65(4):737-54. doi: 10.1111/j.1365-2648.2008.04925.x. Epub 2009 Feb 9. Review. — View Citation

Rethlefsen SA, Ryan DD, Kay RM. Classification systems in cerebral palsy. Orthop Clin North Am. 2010 Oct;41(4):457-67. doi: 10.1016/j.ocl.2010.06.005. Review. — View Citation

Sankar C, Mundkur N. Cerebral palsy-definition, classification, etiology and early diagnosis. Indian J Pediatr. 2005 Oct;72(10):865-8. Review. — View Citation

Schiariti V, Selb M, Cieza A, O'Donnell M. International Classification of Functioning, Disability and Health Core Sets for children and youth with cerebral palsy: a consensus meeting. Dev Med Child Neurol. 2015 Feb;57(2):149-58. doi: 10.1111/dmcn.12551. Epub 2014 Aug 6. — View Citation

Scrutton, D., Management of the motor disorders of children with cerebral palsy. 1984: Cambridge University Press.

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

Woollacott MH, Shumway-Cook A. Postural dysfunction during standing and walking in children with cerebral palsy: what are the underlying problems and what new therapies might improve balance? Neural Plast. 2005;12(2-3):211-9; discussion 263-72. Review. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go test (TUG)	A line was marked on floor at a distance at a distance of 3 meters (9.8 feet) leveled walking. A score of 30 seconds or more suggests that the person may be prone to falls. Alternatively, a recommended practical cut-off value for the TUG to indicate normal versus below normal performance is 12 seconds.	6th week
Primary	Functional Walking Test (FWT)	The purpose of function walk test is to evaluate the walking balance and functional walking ability of a child. It has 5 main components. With different scores each, that is 3, 2 and 1. Also it specifies if there is any asymmetry between Right and Left lower limb and better limb functioning is recorded. Total score of FWT is 23 points	6th week
Primary	Modified Ashworth scale (MAS)	The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform.; A score of 1 indicates no resistance, and 5 indicates rigidity.	6th week
Primary	Gross Motor Function Classification System (GMFCS)	GMFCS divides the CP children into 5 levels, where level 1 is the least affected and most functional children and level 5 most affected and least functional.	6th week