A Motor Learning Intervention to Target Walking Performance in Ambulant Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— MOBILE  

Official title:

A "MOtor Learning Based Intervention for Lower Extremities (MOBILE)" to Target Walking Performance in Ambulant Children With Cerebral Palsy: A Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06454656
• Other study ID #: 23-163
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: Royal College of Surgeons, Ireland
• Contact: Caitriona M O'Shaughnessy
• Phone: 0833128927
• Email: caitrionaoshaug22[@]rcsi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy
• Mobility Limitation
• Paralysis
• Spastic Diplegia
• Walking, Difficulty

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Percentage of eligible numbers recruited	rolling recruitment over 1.5 years
Primary	Adherence to Intervention	Percentage of total hours practiced/ planned dose (30 hours)	Duration of study 2 years
Primary	Retention	Percentage of recruited participants at final follow up	Duration of study 2 years
Primary	Adverse Events	Measured as Yes or No with description	Duration of study 2 years
Primary	Fidelity to Intervention Protocol	Checklist to measure extent of motor learning principles included in sessions	Duration of study 2 years
Primary	Feasibility of Outcome Measures (Participant)	Participant experience of outcomes captured by semi-structured interviews.	Duration of study 2 years
Primary	Feasibility of Outcome Measures (Assessor)	Assessor experience of outcomes captured by semi-structured interview.	Duration of study 2 years
Primary	Acceptability of Intervention	Semi-structured interviews of participants and parents to capture acceptability of intervention using Framework of acceptability	Duration of study 2 years
Primary	Time taken to complete Outcome Measures	Measured in Minutes	Duration of study 2 years
Secondary	Gait Outcome Assessment List	parent/self-report questionnaire developed to measure functional mobility and goals for ambulant children with CP	baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
Secondary	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. This measure will be used to power a future definitive trial.	baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
Secondary	10 meter self-selected walking speed	habitual walking speed selected as it correlates well with habitual physical activities.	baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
Secondary	Modified timed up and go	tests balance and basic mobility in children with physical disabilities and has been validated for use in CP	baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
Secondary	ankle and knee Range of motion	CPIP measures of ankle DF and popliteal angle	baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
Secondary	Child Health Utilities Index CHU-9D	self-report measure that can calculate quality adjusted life years to measure quality of life.	baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years