- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01633736
Targeted Hip Strength Training in Children With Cerebral Palsy (CP)
July 3, 2012 updated by: University of Nottingham
Targeted Hip Progressive Resistance Training to Improve Single Leg Balance and Walking in Children With Cerebral Palsy
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
- Recruiting
- Divison of Physiotherapy, School of Nursing, Midwifery and Physiotherapy, The University of Nottingham
-
Contact:
- Grahame Pope
- Email: grahame.pope@nottingham.ac.uk
-
Principal Investigator:
- Sarah E Westwater-Wood
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 16 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children with CP aged between 7-16 years having sufficient cognition to undertake a strength training program
Exclusion Criteria:
- non-ambulation children or those unable to walk 5 meters independently (without walking aid),
- lower limb surgery within 12 months,
- botox within 6 months,
- oral muscle relaxant medication
- significant learning difficulty
- Any concurrent condition which would be contraindicated to progressive resistance training such as unmanaged high blood pressure, cardiac pathology or uncontrolled epilepsy
- Where at baseline assessment finds no weakness in the muscles under investigation
- concurrent or within 6 months involvement in any other research study
- Non consent to General Practitioner (GP) notification.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: home progressive resistance exercise
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait parameter
Time Frame: baseline, plus 8 weeks and plus 8 weeks (exit point)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function Measure (GMFM)
Time Frame: Baseline, plus 8 weeks and plus 8 weeks (exit)
|
To investigate any change in dimensions D and E of fucntioal activity with standardised GMFM.
|
Baseline, plus 8 weeks and plus 8 weeks (exit)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Grahame Pope, MPhil, BSc, The University of Nottingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Reddihough DS, Collins KJ. The epidemiology and causes of cerebral palsy. Aust J Physiother. 2003;49(1):7-12. doi: 10.1016/s0004-9514(14)60183-5.
- 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. doi: 10.1017/S0012162206000211.
- Koman LA, Smith BP, Shilt JS. Cerebral palsy. Lancet. 2004 May 15;363(9421):1619-31. doi: 10.1016/S0140-6736(04)16207-7.
- Krigger KW. Cerebral palsy: an overview. Am Fam Physician. 2006 Jan 1;73(1):91-100.
- 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. doi: 10.1046/j.1365-2214.2002.00304.x.
- 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.
- Pallant, J (2001) SPSS Survival Manual. Edition 10, Open University Press, Buckingham.Philadelphia
- 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. doi: 10.1017/s0012162203000999.
- Levitt, S., Treatment of Cerebral Palsy and Motor Delay. 3rd Edition ed. 1995: Blackwell Science.
- 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. doi: 10.1017/s0012162201001852.
- Wiley ME, Damiano DL. Lower-extremity strength profiles in spastic cerebral palsy. Dev Med Child Neurol. 1998 Feb;40(2):100-7. doi: 10.1111/j.1469-8749.1998.tb15369.x.
- 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. doi: 10.1093/ptj/75.8.658.
- Tran, Q.T., Cerebral palsy; considerations for training. Strength and Conditioning Journal, 2005. 27(6): p. 34-38
- 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. doi: 10.1017/s0012162201001682. No abstract available.
- 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. doi: 10.1053/apmr.2002.34286.
- 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. No abstract available.
- 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. doi: 10.1191/0269215505cr804oa.
- Lee JH, Sung IY, Yoo JY. Therapeutic effects of strengthening exercise on gait function of cerebral palsy. Disabil Rehabil. 2008;30(19):1439-44. doi: 10.1080/09638280701618943.
- 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.
- 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. doi: 10.1191/0269215503cr584oa.
- Damiano DL, Abel MF. Functional outcomes of strength training in spastic cerebral palsy. Arch Phys Med Rehabil. 1998 Feb;79(2):119-25. doi: 10.1016/s0003-9993(98)90287-8.
- 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. doi: 10.1016/j.gaitpost.2007.07.008. Epub 2007 Sep 12.
- 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.
- 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.
- 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. doi: 10.1249/mss.0b013e3181453694.
- Perry, J., Gait Analysis Normal and Pathological Function. 1992, Thorofare, NJ: SLACK Inc. 502.
- Gage, J., The treatment on gait problems in cerebral palsy. 2004: MAcKeith Press.
- Palastanga, N., D. Field, and R. Soames, Anatomy and Human Movement structure and function Vol. 5th. 2006: Elsevier.
- 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.
- Anttila H, Autti-Ramo I, Suoranta J, Makela 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.
- 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. doi: 10.1097/PHM.0b013e31815b2675.
- Armstrong, N. and W. van Mechelen, Paediatric exercise science and medicine. 2nd ed. 2008: Oxford University Press
- 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. No abstract available.
- 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. doi: 10.1016/j.apmr.2006.10.006.
- Patikas D, Wolf SI, Mund K, Armbrust P, Schuster W, Doderlein 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. doi: 10.1016/j.apmr.2006.01.023.
- Brooks, G., Fahey. TD., and K. Baldwin, Exercise physiology; human bioenergetics and its applications. 4th ed. 2004: McGraw Hill.
- 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.
- Patikas D, Wolf SI, Armbrust P, Mund K, Schuster W, Dreher T, Doderlein 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. doi: 10.1016/j.apmr.2006.05.014.
- 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. doi: 10.1001/archpedi.161.11.1075.
- 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. doi: 10.1016/j.apmr.2003.12.037.
- van den Beld WA, van der Sanden GA, Sengers RC, Verbeek AL, Gabreels FJ. Validity and reproducibility of hand-held dynamometry in children aged 4-11 years. J Rehabil Med. 2006 Jan;38(1):57-64. doi: 10.1080/16501970510044043.
- 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. doi: 10.1017/S001216220600096X.
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (ANTICIPATED)
March 1, 2013
Study Completion (ANTICIPATED)
March 1, 2013
Study Registration Dates
First Submitted
June 15, 2012
First Submitted That Met QC Criteria
July 3, 2012
First Posted (ESTIMATE)
July 4, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
July 4, 2012
Last Update Submitted That Met QC Criteria
July 3, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UoN-SWW-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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