A Motor Learning Intervention to Target Walking Performance in Ambulant Children With Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MOBILE.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy, Walking, Difficulty, Spastic Diplegia, Hemiplegic Cerebral Palsy. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A "MOtor Learning Based Intervention for Lower Extremities (MOBILE)" to Target Walking Performance in Ambulant Children With Cerebral Palsy: A Feasibility Study
Overview
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.
Interventions
- Other MOBILE
Intensive motor learning based intervention to target specific walking goals as identified using the Gait Outcome Assessment List. Full Protocol outlining strategies available on request. Three key principles underpin the intervention: Principle 1: The type of task Principle 2: The type of practice Principle 3: The type of Feedback
Primary outcome measures
- Recruitment Rate [Time frame: rolling recruitment over 1.5 years]
- Adherence to Intervention [Time frame: Duration of study 2 years]
- Retention [Time frame: Duration of study 2 years]
- Adverse Events [Time frame: Duration of study 2 years]
- Fidelity to Intervention Protocol [Time frame: Duration of study 2 years]
- Feasibility of Outcome Measures (Participant) [Time frame: Duration of study 2 years]
- Feasibility of Outcome Measures (Assessor) [Time frame: Duration of study 2 years]
- Acceptability of Intervention [Time frame: Duration of study 2 years]
- Time taken to complete Outcome Measures [Time frame: Duration of study 2 years]
Secondary outcome measures (6)
- Gait Outcome Assessment List [Time frame: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years]
- 6 minute walk test [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Ireland · 1 center
- Enable Ireland Bangla Therapy Centre — Balrath
Identifiers
NCT: NCT06454656 · 23-163