A "MOtor Learning Based Intervention for Lower Extremities (MOBILE)" to Target Walking Performance in Ambulant Children With Cerebral Palsy: A Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- MOBILE
- Conditions
- Cerebral Palsy
- Sponsor
- Royal College of Surgeons, Ireland
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Fidelity to Intervention Protocol
- Status
- Recruiting
- Last Updated
- 18 days ago
Overview
Brief Summary
The goal of this clinical trial is to learn if a new therapy approach to improve walking ability in children with Cerebral Palsy is acceptable to the children and the families in a community setting.
The main questions we look to answer are:
- Do the children/teens tolerate the therapy and feel that it is helpful?
- Do the parents/ families feel the therapy helps and is easy to commit to?
- Do the children/teens complete all their therapy sessions and assessments as planned?
The participants will trial the therapy for 30 hours over 6 weeks and will perform assessments before and after to see if they meet their goals. They will also be interviewed to see how they felt about the therapy when they finish.
Detailed Description
The therapy being trialed in this study uses motor learning theory to try and improve or change walking patterns to improve the child/teen's walking goal. Therapy will target their own walking goal and they can choose the format of their therapy as long as they complete 30 hours of which 24 hours must be in the clinic within a 6 week period.
Investigators
Catriona O'Shaughnessy
Professional Doctorate Scholar
Royal College of Surgeons, Ireland
Eligibility Criteria
Inclusion Criteria
- •Primary diagnosis of Cerebral Palsy (GMFCS Levels I-III)
- •Has a specific walking related goal
- •Has capacity to follow instruction
- •Has a primary caregiver who can support a home program
Exclusion Criteria
- •Has had surgery within 6 months of intervention start date
- •Has had botox/ baclofen within 3 months of intervention start date
- •Has a dual diagnosis that impacts ability to follow instruction
- •Has a significant cognitive impairment
Arms & Interventions
Intervention
Participants will undergo 30 hours of therapy over 6 weeks in format of their choosing. A minimum of 24 hours must be completed in clinic with the rest made up of home program.
Intervention: MOBILE
Outcomes
Primary Outcomes
Fidelity to Intervention Protocol
Time Frame: Duration of study 2 years
Checklist to measure extent of motor learning principles included in sessions
Adherence to Intervention
Time Frame: Duration of study 2 years
Percentage of total hours practiced/ planned dose (30 hours)
Feasibility of Outcome Measures (Participant)
Time Frame: Duration of study 2 years
Participant experience of outcomes captured by semi-structured interviews.
Acceptability of Intervention
Time Frame: Duration of study 2 years
Semi-structured interviews of participants and parents to capture acceptability of intervention using Framework of acceptability
Retention
Time Frame: Duration of study 2 years
Percentage of recruited participants at final follow up
Adverse Events
Time Frame: Duration of study 2 years
Measured as Yes or No with description
Recruitment Rate
Time Frame: rolling recruitment over 1.5 years
Percentage of eligible numbers recruited
Time taken to complete Outcome Measures
Time Frame: Duration of study 2 years
Measured in Minutes
Feasibility of Outcome Measures (Assessor)
Time Frame: Duration of study 2 years
Assessor experience of outcomes captured by semi-structured interview.
Secondary Outcomes
- Gait Outcome Assessment List(baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years)
- 10 meter self-selected walking speed(baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years)
- Modified timed up and go(baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years)
- 6 minute walk test(baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years)
- ankle and knee Range of motion(baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years)
- Child Health Utilities Index CHU-9D(baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years)