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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Nottingham.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01633736
First received: June 15, 2012
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Cerebral Palsy
Other: Usual care plus progresive resistance training
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeted Hip Progressive Resistance Training to Improve Single Leg Balance and Walking in Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Gait parameter [ Time Frame: baseline, plus 8 weeks and plus 8 weeks (exit point) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, plus 8 weeks and plus 8 weeks (exit) ] [ Designated as safety issue: No ]
    To investigate any change in dimensions D and E of fucntioal activity with standardised GMFM.


Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: home progressive resistance exercise 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.
Other Name: strength training

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

  Eligibility

Ages Eligible for Study:   7 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633736

Contacts
Contact: Sarah E Westwater-Wood, MMedSci, BSc +44 115 8231793 sarah.westwater-wood@nottingham.ac.uk
Contact: Grahame Pope, MPhil, BSc +44 115 8231785 grahame.pope@nottingham.ac.uk

Locations
United Kingdom
Divison of Physiotherapy, School of Nursing, Midwifery and Physiotherapy, The University of Nottingham Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Contact: Grahame Pope       grahame.pope@nottingham.ac.uk   
Principal Investigator: Sarah E Westwater-Wood         
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Grahame Pope, MPhil, BSc The University of Nottingham
  More Information

Publications:
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.
Jung Hwan Lee, In young Sung, and J.Y. Yoo, Therapeutic effects of strengthening exercises on gait function of cerebral palsy. Disability and Rehabilitation, 2007. 30(9): p. 1439-1444.

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01633736     History of Changes
Other Study ID Numbers: UoN-SWW-2
Study First Received: June 15, 2012
Last Updated: July 3, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
single blinded
randomised
controlled
physiotherapy
children
cerebral palsy

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014