Targeted Hip Strength Training in Children With Cerebral Palsy (CP)
Primary Purpose
Cerebral Palsy
Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Usual care plus progresive resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring single blinded, randomised, controlled, physiotherapy, children, cerebral palsy
Eligibility Criteria
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.
Sites / Locations
- Divison of Physiotherapy, School of Nursing, Midwifery and Physiotherapy, The University of NottinghamRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
home progressive resistance exercise
Arm Description
Outcomes
Primary Outcome Measures
Gait parameter
4 camera CODA gait analysis system for change in percentage stance phase of gait and stride in cm.
Secondary Outcome Measures
Gross Motor Function Measure (GMFM)
To investigate any change in dimensions D and E of fucntioal activity with standardised GMFM.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01633736
Brief Title
Targeted Hip Strength Training in Children With Cerebral Palsy (CP)
Official Title
Targeted Hip Progressive Resistance Training to Improve Single Leg Balance and Walking in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
single blinded, randomised, controlled, physiotherapy, children, cerebral palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
home progressive resistance exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Usual care plus progresive resistance training
Other Intervention Name(s)
strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gait parameter
Description
4 camera CODA gait analysis system for change in percentage stance phase of gait and stride in cm.
Time Frame
baseline, plus 8 weeks and plus 8 weeks (exit point)
Secondary Outcome Measure Information:
Title
Gross Motor Function Measure (GMFM)
Description
To investigate any change in dimensions D and E of fucntioal activity with standardised GMFM.
Time Frame
Baseline, plus 8 weeks and plus 8 weeks (exit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah E Westwater-Wood, MMedSci, BSc
Phone
+44 115 8231793
Email
sarah.westwater-wood@nottingham.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Grahame Pope, MPhil, BSc
Phone
+44 115 8231785
Email
grahame.pope@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grahame Pope, MPhil, BSc
Organizational Affiliation
The University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Divison of Physiotherapy, School of Nursing, Midwifery and Physiotherapy, The University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grahame Pope
Email
grahame.pope@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
Sarah E Westwater-Wood
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
12600249
Citation
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.
Results Reference
background
PubMed Identifier
16417662
Citation
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.
Results Reference
background
PubMed Identifier
15145637
Citation
Koman LA, Smith BP, Shilt JS. Cerebral palsy. Lancet. 2004 May 15;363(9421):1619-31. doi: 10.1016/S0140-6736(04)16207-7.
Results Reference
background
PubMed Identifier
16417071
Citation
Krigger KW. Cerebral palsy: an overview. Am Fam Physician. 2006 Jan 1;73(1):91-100.
Results Reference
background
PubMed Identifier
12568476
Citation
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.
Results Reference
background
PubMed Identifier
18355333
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.
Results Reference
background
Citation
Pallant, J (2001) SPSS Survival Manual. Edition 10, Open University Press, Buckingham.Philadelphia
Results Reference
background
PubMed Identifier
12882533
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. doi: 10.1017/s0012162203000999.
Results Reference
background
Citation
Levitt, S., Treatment of Cerebral Palsy and Motor Delay. 3rd Edition ed. 1995: Blackwell Science.
Results Reference
background
PubMed Identifier
12005315
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. doi: 10.1017/s0012162201001852.
Results Reference
background
PubMed Identifier
18842125
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.
Results Reference
background
PubMed Identifier
9489498
Citation
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.
Results Reference
background
PubMed Identifier
7644570
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. doi: 10.1093/ptj/75.8.658.
Results Reference
background
Citation
Tran, Q.T., Cerebral palsy; considerations for training. Strength and Conditioning Journal, 2005. 27(6): p. 34-38
Results Reference
background
PubMed Identifier
11811654
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. doi: 10.1017/s0012162201001682. No abstract available.
Results Reference
background
PubMed Identifier
12161840
Citation
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.
Results Reference
background
PubMed Identifier
15330697
Citation
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.
Results Reference
background
PubMed Identifier
15859529
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. doi: 10.1191/0269215505cr804oa.
Results Reference
background
PubMed Identifier
19230216
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. doi: 10.1080/09638280701618943.
Results Reference
background
PubMed Identifier
11380277
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.
Results Reference
background
PubMed Identifier
12617379
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. doi: 10.1191/0269215503cr584oa.
Results Reference
background
PubMed Identifier
9473991
Citation
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.
Results Reference
background
PubMed Identifier
17855096
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. doi: 10.1016/j.gaitpost.2007.07.008. Epub 2007 Sep 12.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
17108800
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.
Results Reference
background
PubMed Identifier
17986896
Citation
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.
Results Reference
background
Citation
Perry, J., Gait Analysis Normal and Pathological Function. 1992, Thorofare, NJ: SLACK Inc. 502.
Results Reference
background
PubMed Identifier
11727367
Citation
Gage JR, Novacheck TF. An update on the treatment of gait problems in cerebral palsy. J Pediatr Orthop B. 2001 Oct;10(4):265-74.
Results Reference
background
Citation
Palastanga, N., D. Field, and R. Soames, Anatomy and Human Movement structure and function Vol. 5th. 2006: Elsevier.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
18435840
Citation
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.
Results Reference
background
PubMed Identifier
17993987
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. doi: 10.1097/PHM.0b013e31815b2675.
Results Reference
background
Citation
Armstrong, N. and W. van Mechelen, Paediatric exercise science and medicine. 2nd ed. 2008: Oxford University Press
Results Reference
background
PubMed Identifier
2235239
Citation
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.
Results Reference
background
PubMed Identifier
17207671
Citation
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.
Results Reference
background
PubMed Identifier
16635623
Citation
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.
Results Reference
background
Citation
Brooks, G., Fahey. TD., and K. Baldwin, Exercise physiology; human bioenergetics and its applications. 4th ed. 2004: McGraw Hill.
Results Reference
background
PubMed Identifier
18461111
Citation
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.
Results Reference
background
PubMed Identifier
16935049
Citation
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.
Results Reference
background
PubMed Identifier
17984410
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. doi: 10.1001/archpedi.161.11.1075.
Results Reference
background
PubMed Identifier
15605348
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. doi: 10.1016/j.apmr.2003.12.037.
Results Reference
background
PubMed Identifier
16548089
Citation
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.
Results Reference
background
PubMed Identifier
16700934
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. doi: 10.1017/S001216220600096X.
Results Reference
background
Citation
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
Results Reference
background
Learn more about this trial
Targeted Hip Strength Training in Children With Cerebral Palsy (CP)
We'll reach out to this number within 24 hrs