A Motor Learning Intervention to Target Walking Performance in Ambulant Children With Cerebral Palsy
- Conditions
- Cerebral PalsyWalking, DifficultyHemiplegic Cerebral PalsySpastic Diplegia
- Interventions
- Other: MOBILE
- Registration Number
- NCT06454656
- Lead Sponsor
- Royal College of Surgeons, Ireland
- 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:
1. Do the children/teens tolerate the therapy and feel that it is helpful?
2. Do the parents/ families feel the therapy helps and is easy to commit to?
3. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention MOBILE 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.
- Primary Outcome Measures
Name Time Method Fidelity to Intervention Protocol Duration of study 2 years Checklist to measure extent of motor learning principles included in sessions
Adherence to Intervention Duration of study 2 years Percentage of total hours practiced/ planned dose (30 hours)
Feasibility of Outcome Measures (Participant) Duration of study 2 years Participant experience of outcomes captured by semi-structured interviews.
Acceptability of Intervention Duration of study 2 years Semi-structured interviews of participants and parents to capture acceptability of intervention using Framework of acceptability
Retention Duration of study 2 years Percentage of recruited participants at final follow up
Adverse Events Duration of study 2 years Measured as Yes or No with description
Recruitment Rate rolling recruitment over 1.5 years Percentage of eligible numbers recruited
Time taken to complete Outcome Measures Duration of study 2 years Measured in Minutes
Feasibility of Outcome Measures (Assessor) Duration of study 2 years Assessor experience of outcomes captured by semi-structured interview.
- Secondary Outcome Measures
Name Time Method Gait Outcome Assessment List baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years parent/self-report questionnaire developed to measure functional mobility and goals for ambulant children with CP. This measure will be used to power a future definitive trial.
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 habitual walking speed selected as it correlates well with habitual physical activities.
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 tests balance and basic mobility in children with physical disabilities and has been validated for use in CP
6 minute walk test baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years This is a measure of gait endurance and has been validated for use in CP. Gait speed will also be calculated using this measure.
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 CPIP measures of ankle DF and popliteal angle
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 self-report measure that can calculate quality adjusted life years to measure quality of life.
Trial Locations
- Locations (1)
Enable Ireland Bangla Therapy Centre
🇮🇪Balrath, Meath, Ireland