NCT01633736

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

1.2 years

First QC Date

June 15, 2012

Last Update Submit

July 3, 2012

Conditions

Keywords

single blindedrandomisedcontrolledphysiotherapychildrencerebral palsy

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Gross Motor Function Measure (GMFM)

    Baseline, plus 8 weeks and plus 8 weeks (exit)

Study Arms (1)

home progressive resistance exercise

EXPERIMENTAL
Other: Usual care plus progresive resistance training

Interventions

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.

Also known as: strength training
home progressive resistance exercise

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Divison of Physiotherapy, School of Nursing, Midwifery and Physiotherapy, The University of Nottingham

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

RECRUITING

Related Publications (45)

  • 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.

    BACKGROUND
  • 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.

    PMID: 12600249BACKGROUND
  • 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.

    PMID: 16417662BACKGROUND
  • Koman LA, Smith BP, Shilt JS. Cerebral palsy. Lancet. 2004 May 15;363(9421):1619-31. doi: 10.1016/S0140-6736(04)16207-7.

    PMID: 15145637BACKGROUND
  • Krigger KW. Cerebral palsy: an overview. Am Fam Physician. 2006 Jan 1;73(1):91-100.

    PMID: 16417071BACKGROUND
  • 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.

    PMID: 12568476BACKGROUND
  • 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.

    PMID: 18355333BACKGROUND
  • Pallant, J (2001) SPSS Survival Manual. Edition 10, Open University Press, Buckingham.Philadelphia

    BACKGROUND
  • 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.

    PMID: 12882533BACKGROUND
  • Levitt, S., Treatment of Cerebral Palsy and Motor Delay. 3rd Edition ed. 1995: Blackwell Science.

    BACKGROUND
  • 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.

    PMID: 12005315BACKGROUND
  • 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.

    PMID: 18842125BACKGROUND
  • 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.

    PMID: 9489498BACKGROUND
  • 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.

    PMID: 7644570BACKGROUND
  • Tran, Q.T., Cerebral palsy; considerations for training. Strength and Conditioning Journal, 2005. 27(6): p. 34-38

    BACKGROUND
  • 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.

    PMID: 11811654BACKGROUND
  • 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.

    PMID: 12161840BACKGROUND
  • 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.

    PMID: 15330697BACKGROUND
  • 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.

    PMID: 15859529BACKGROUND
  • 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.

    PMID: 19230216BACKGROUND
  • 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.

    PMID: 11380277BACKGROUND
  • 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.

    PMID: 12617379BACKGROUND
  • 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.

    PMID: 9473991BACKGROUND
  • 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.

    PMID: 17855096BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 17108800BACKGROUND
  • 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.

    PMID: 17986896BACKGROUND
  • Perry, J., Gait Analysis Normal and Pathological Function. 1992, Thorofare, NJ: SLACK Inc. 502.

    BACKGROUND
  • 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.

    PMID: 11727367BACKGROUND
  • Palastanga, N., D. Field, and R. Soames, Anatomy and Human Movement structure and function Vol. 5th. 2006: Elsevier.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 18435840BACKGROUND
  • 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.

    PMID: 17993987BACKGROUND
  • Armstrong, N. and W. van Mechelen, Paediatric exercise science and medicine. 2nd ed. 2008: Oxford University Press

    BACKGROUND
  • 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.

    PMID: 2235239BACKGROUND
  • 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.

    PMID: 17207671BACKGROUND
  • 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.

    PMID: 16635623BACKGROUND
  • Brooks, G., Fahey. TD., and K. Baldwin, Exercise physiology; human bioenergetics and its applications. 4th ed. 2004: McGraw Hill.

    BACKGROUND
  • 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.

    PMID: 18461111BACKGROUND
  • 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.

    PMID: 16935049BACKGROUND
  • 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.

    PMID: 17984410BACKGROUND
  • 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.

    PMID: 15605348BACKGROUND
  • 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.

    PMID: 16548089BACKGROUND
  • 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.

    PMID: 16700934BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Grahame Pope, MPhil, BSc

    The University of Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah E Westwater-Wood, MMedSci, BSc

CONTACT

Grahame Pope, MPhil, BSc

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2012

First Posted

July 4, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations