Targeted Hip Strength Training in Children With Cerebral Palsy (CP)

Cerebral Palsy Clinical Trial

Official title:

Targeted Hip Progressive Resistance Training to Improve Single Leg Balance and Walking in Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01633736
• Other study ID #: UoN-SWW-2
• Status: Recruiting
• Phase: Phase 3
• First received: June 15, 2012
• Last updated: July 3, 2012
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: July 2012
• Source: University of Nottingham
• Contact: Sarah E Westwater-Wood, MMedSci, BSc
• Phone: +44 115 8231793
• Email: sarah.westwater-wood[@]nottingham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study's main aim is to look at targeted strength training for muscles at the hips. Specifically to consider whether targeted strength training not only effects strength of the specific muscles but also ability to stand on one leg (single leg balance) as well as walking in children with cerebral palsy? This study is a feasibility of method of investigation.

Description:

This study is focusing on functional change. The reasoning is that if the targeted strength training is effective at improving hip muscle contribution to stability then single leg balance may be improved. This may be functionally evident when weight bearing is taken by say the left leg in gait (percentage stance phase of gait) and as a consequence the opposing swing phase will be optimised as measured by stride. Thus the research question is does strengthening of the rotating and sideways moving hip muscles improve the walking of children with CP as measured by appropriate aspects of gait? Secondly, does this targeted strengthening also increase duration of single leg balance which is a simple easy to use measure in the community without the need for specialised equipment? The primary outcome measure will use a laboratory based 4 camera Codsmotion (CODA) biomechanical analysis system to measure stride (a) and percentage duration of stance phase of gait (b). Secondarily the duration of single leg balance in terms of seconds will be recorded. Gross motor functional and quality of life as also being assessed. The intervention is strengthening which will be implemented with the principles of progressive resistance training. Children with CP's therapists would ask for this type of intervention to be carried out

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 16 Years

Eligibility

Inclusion Criteria:

• Children with CP aged between 7-16 years having sufficient cognition to undertake a strength training program

Exclusion Criteria:

1. non-ambulation children or those unable to walk 5 meters independently (without walking aid),

2. lower limb surgery within 12 months,

3. botox within 6 months,

4. oral muscle relaxant medication

5. significant learning difficulty

6. Any concurrent condition which would be contraindicated to progressive resistance training such as unmanaged high blood pressure, cardiac pathology or uncontrolled epilepsy

7. Where at baseline assessment finds no weakness in the muscles under investigation

8. concurrent or within 6 months involvement in any other research study

9. Non consent to General Practitioner (GP) notification.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Usual care plus progresive resistance training
Duration 8 weeks; two weeks of familiarisation with the intervention protocol without resistance (for familiarisation and neural adaptation) followed by 6 weeks progressive resistance (PR). The three times a week PR training will be as a home exercise program with fortnightly home visits to monitor/progress PR training. It comprises a 4 minute warm up and cool down with one exercise targeting the hip abductors and one the lateral rotators. Exercise prescription will follow existing guidelines for progressive PR training. Parents will be taught supervision by the researcher using clear explanations in words and pictures in a logbook. Logbooks have been found to facilitate compliance, dosage and motivation.

Locations

Country	Name	City	State
United Kingdom	Divison of Physiotherapy, School of Nursing, Midwifery and Physiotherapy, The University of Nottingham	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (45)

American Academy of Pediatrics Committee on Sports Medicine: Strength training, weight and power lifting, and body building by children and adolescents. Pediatrics. 1990 Nov;86(5):801-3. — View Citation

Anttila H, Autti-Rämö I, Suoranta J, Mäkelä M, Malmivaara A. Effectiveness of physical therapy interventions for children with cerebral palsy: a systematic review. BMC Pediatr. 2008 Apr 24;8:14. doi: 10.1186/1471-2431-8-14. Review. — View Citation

Armstrong, N. and W. van Mechelen, Paediatric exercise science and medicine. 2nd ed. 2008: Oxford University Press

Behm DG, Faigenbaum AD, Falk B, Klentrou P. Canadian Society for Exercise Physiology position paper: resistance training in children and adolescents. Appl Physiol Nutr Metab. 2008 Jun;33(3):547-61. doi: 10.1139/H08-020. — View Citation

Blundell SW, Shepherd RB, Dean CM, Adams RD, Cahill BM. Functional strength training in cerebral palsy: a pilot study of a group circuit training class for children aged 4-8 years. Clin Rehabil. 2003 Feb;17(1):48-57. — View Citation

Brooks, G., Fahey. TD., and K. Baldwin, Exercise physiology; human bioenergetics and its applications. 4th ed. 2004: McGraw Hill.

Cans, C., et al., Recommendations from the SCPE collaborative group for defining and classifying cerebral palsy. , in The Definition and Classification of Cerebral Palsy, P. Baxter, Editor. 2003, the SCPE collaborative group.

Coe R (2002) It's the Effect Size, Stupid; What effect size is and why it is important Paper presented at the Annual Conference of the British Educational Research Association, University of Exeter, England, 12-14 September 2002

Damiano DL, Abel MF. Functional outcomes of strength training in spastic cerebral palsy. Arch Phys Med Rehabil. 1998 Feb;79(2):119-25. — View Citation

Damiano DL, Dodd K, Taylor NF. Should we be testing and training muscle strength in cerebral palsy? Dev Med Child Neurol. 2002 Jan;44(1):68-72. — View Citation

Damiano DL, Kelly LE, Vaughn CL. Effects of quadriceps femoris muscle strengthening on crouch gait in children with spastic diplegia. Phys Ther. 1995 Aug;75(8):658-67; discussion 668-71. — View Citation

Darrah, J., et al., Review of the effects of progressive resisted muscle strengthening in children with cerebral palsy: a clinical consensus exercise. Pediatric Physical Therapy, 1997. 9: p. 12-17.

Dodd KJ, Taylor NF, Damiano DL. A systematic review of the effectiveness of strength-training programs for people with cerebral palsy. Arch Phys Med Rehabil. 2002 Aug;83(8):1157-64. Review. — View Citation

Elder GC, Kirk J, Stewart G, Cook K, Weir D, Marshall A, Leahey L. Contributing factors to muscle weakness in children with cerebral palsy. Dev Med Child Neurol. 2003 Aug;45(8):542-50. — 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. — View Citation

Fowler EG, Ho TW, Nwigwe AI, Dorey FJ. The effect of quadriceps femoris muscle strengthening exercises on spasticity in children with cerebral palsy. Phys Ther. 2001 Jun;81(6):1215-23. — View Citation

Gage, J., The treatment on gait problems in cerebral palsy. 2004: MAcKeith Press.

Hemming K, Hutton JL, Pharoah PO. Long-term survival for a cohort of adults with cerebral palsy. Dev Med Child Neurol. 2006 Feb;48(2):90-5. — View Citation

Himpens E, Van den Broeck C, Oostra A, Calders P, Vanhaesebrouck P. Prevalence, type, distribution, and severity of cerebral palsy in relation to gestational age: a meta-analytic review. Dev Med Child Neurol. 2008 May;50(5):334-40. doi: 10.1111/j.1469-8749.2008.02047.x. Epub 2008 Mar 18. Review. — View Citation

Johnson, L.M., et al., The effect of plantarflexor muscle strengthening on the gait and range of motion at the ankle in ambulant children with cerebral palsy: a pilot study. New Zealand Journal of Physiotherapy, 1998. April: p. 8-14.

Koman LA, Smith BP, Shilt JS. Cerebral palsy. Lancet. 2004 May 15;363(9421):1619-31. Review. — View Citation

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

Lee JH, Sung IY, Yoo JY. Therapeutic effects of strengthening exercise on gait function of cerebral palsy. Disabil Rehabil. 2008;30(19):1439-44. — View Citation

Levitt, S., Treatment of Cerebral Palsy and Motor Delay. 3rd Edition ed. 1995: Blackwell Science.

Liao HF, Liu YC, Liu WY, Lin YT. Effectiveness of loaded sit-to-stand resistance exercise for children with mild spastic diplegia: a randomized clinical trial. Arch Phys Med Rehabil. 2007 Jan;88(1):25-31. — View Citation

Morton JF, Brownlee M, McFadyen AK. The effects of progressive resistance training for children with cerebral palsy. Clin Rehabil. 2005 May;19(3):283-9. — View Citation

Palastanga, N., D. Field, and R. Soames, Anatomy and Human Movement structure and function Vol. 5th. 2006: Elsevier.

Pallant, J (2001) SPSS Survival Manual. Edition 10, Open University Press, Buckingham.Philadelphia

Parkes J, Donnelly M, Dolk H, Hill N. Use of physiotherapy and alternatives by children with cerebral palsy: a population study. Child Care Health Dev. 2002 Nov;28(6):469-77. — View Citation

Patikas D, Wolf SI, Armbrust P, Mund K, Schuster W, Dreher T, Döderlein L. Effects of a postoperative resistive exercise program on the knee extension and flexion torque in children with cerebral palsy: a randomized clinical trial. Arch Phys Med Rehabil. 2006 Sep;87(9):1161-9. — View Citation

Patikas D, Wolf SI, Mund K, Armbrust P, Schuster W, Döderlein L. Effects of a postoperative strength-training program on the walking ability of children with cerebral palsy: a randomized controlled trial. Arch Phys Med Rehabil. 2006 May;87(5):619-26. — View Citation

Perry, J., Gait Analysis Normal and Pathological Function. 1992, Thorofare, NJ: SLACK Inc. 502.

Pippenger WS, Scalzitti DA. What are the effects, if any, of lower-extremity strength training on gait in children with cerebral palsy? Phys Ther. 2004 Sep;84(9):849-58. — View Citation

Reddihough DS, Collins KJ. The epidemiology and causes of cerebral palsy. Aust J Physiother. 2003;49(1):7-12. Review. — View Citation

Ross SA, Engsberg JR. Relation between spasticity and strength in individuals with spastic diplegic cerebral palsy. Dev Med Child Neurol. 2002 Mar;44(3):148-57. — View Citation

Scholtes VA, Dallmeijer AJ, Rameckers EA, Verschuren O, Tempelaars E, Hensen M, Becher JG. Lower limb strength training in children with cerebral palsy--a randomized controlled trial protocol for functional strength training based on progressive resistance exercise principles. BMC Pediatr. 2008 Oct 8;8:41. doi: 10.1186/1471-2431-8-41. — View Citation

Seniorou M, Thompson N, Harrington M, Theologis T. Recovery of muscle strength following multi-level orthopaedic surgery in diplegic cerebral palsy. Gait Posture. 2007 Oct;26(4):475-81. Epub 2007 Sep 12. — View Citation

Tran, Q.T., Cerebral palsy; considerations for training. Strength and Conditioning Journal, 2005. 27(6): p. 34-38

Unnithan VB, Katsimanis G, Evangelinou C, Kosmas C, Kandrali I, Kellis E. Effect of strength and aerobic training in children with cerebral palsy. Med Sci Sports Exerc. 2007 Nov;39(11):1902-9. — View Citation

van den Beld WA, van der Sanden GA, Sengers RC, Verbeek AL, Gabreëls FJ. Validity and reproducibility of hand-held dynamometry in children aged 4-11 years. J Rehabil Med. 2006 Jan;38(1):57-64. — View Citation

van der Linden ML, Aitchison AM, Hazlewood ME, Hillman SJ, Robb JE. Test-Retest repeatability of gluteus maximus strength testing using a fixed digital dynamometer in children with cerebral palsy. Arch Phys Med Rehabil. 2004 Dec;85(12):2058-63. — View Citation

Varni JW, Burwinkle TM, Berrin SJ, Sherman SA, Artavia K, Malcarne VL, Chambers HG. The PedsQL in pediatric cerebral palsy: reliability, validity, and sensitivity of the Generic Core Scales and Cerebral Palsy Module. Dev Med Child Neurol. 2006 Jun;48(6):442-9. — View Citation

Verschuren O, Ketelaar M, Gorter JW, Helders PJ, Uiterwaal CS, Takken T. Exercise training program in children and adolescents with cerebral palsy: a randomized controlled trial. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1075-81. — View Citation

Verschuren O, Ketelaar M, Takken T, Helders PJ, Gorter JW. Exercise programs for children with cerebral palsy: a systematic review of the literature. Am J Phys Med Rehabil. 2008 May;87(5):404-17. Review. — View Citation

Wiley ME, Damiano DL. Lower-extremity strength profiles in spastic cerebral palsy. Dev Med Child Neurol. 1998 Feb;40(2):100-7. — View Citation

* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait parameter	4 camera CODA gait analysis system for change in percentage stance phase of gait and stride in cm.	baseline, plus 8 weeks and plus 8 weeks (exit point)	No
Secondary	Gross Motor Function Measure (GMFM)	To investigate any change in dimensions D and E of fucntioal activity with standardised GMFM.	Baseline, plus 8 weeks and plus 8 weeks (exit)	No