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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
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

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

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

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

First Posted
June 15, 2012
Last Updated
July 3, 2012
Sponsor
University of Nottingham
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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

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

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