A Motor Learning Intervention to Target Walking Performance in Ambulant Children With Cerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorRoyal College of Surgeons, Ireland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MOBILE
Other interventionIntensive 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
Treatment groups
14 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate
Percentage of eligible numbers recruited
Time frame
rolling recruitment over 1.5 years2
Adherence to Intervention
Percentage of total hours practiced/ planned dose (30 hours)
Time frame
Duration of study 2 years3
Retention
Percentage of recruited participants at final follow up
Time frame
Duration of study 2 years4
Adverse Events
Measured as Yes or No with description
Time frame
Duration of study 2 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov