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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
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
Enable Ireland Bangla Therapy Centre
Balrath, Meath, Ireland
RECRUITINGRecruitment Rate
Percentage of eligible numbers recruited
Time frame: rolling recruitment over 1.5 years
Adherence to Intervention
Percentage of total hours practiced/ planned dose (30 hours)
Time frame: Duration of study 2 years
Retention
Percentage of recruited participants at final follow up
Time frame: Duration of study 2 years
Adverse Events
Measured as Yes or No with description
Time frame: Duration of study 2 years
Fidelity to Intervention Protocol
Checklist to measure extent of motor learning principles included in sessions
Time frame: Duration of study 2 years
Feasibility of Outcome Measures (Participant)
Participant experience of outcomes captured by semi-structured interviews.
Time frame: Duration of study 2 years
Feasibility of Outcome Measures (Assessor)
Assessor experience of outcomes captured by semi-structured interview.
Time frame: Duration of study 2 years
Acceptability of Intervention
Semi-structured interviews of participants and parents to capture acceptability of intervention using Framework of acceptability
Time frame: Duration of study 2 years
Time taken to complete Outcome Measures
Measured in Minutes
Time frame: Duration of study 2 years
Gait Outcome Assessment List
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.
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
This is a measure of gait endurance and has been validated for use in CP. Gait speed will also be calculated using this measure.
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
habitual walking speed selected as it correlates well with habitual physical activities.
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
tests balance and basic mobility in children with physical disabilities and has been validated for use in CP
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
CPIP measures of ankle DF and popliteal angle
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
self-report measure that can calculate quality adjusted life years to measure quality of life.
Time frame: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
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