Clinical trial NCT06454656: A Motor Learning Intervention to Target Walking Performance in Ambulant Children With Cerebral Palsy
Official title: A "MOtor Learning Based Intervention for Lower Extremities (MOBILE)" to Target Walking Performance in Ambulant Children With Cerebral Palsy: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Walking, Difficulty
Spastic Diplegia
Hemiplegic Cerebral Palsy
Keywords: Motor Learning Theory
Neuroplasticity
Neurological Rehabilitation
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility Study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment Rate
timeFrame: rolling recruitment over 1.5 years
measure: Adherence to Intervention
timeFrame: Duration of study 2 years
measure: Retention
timeFrame: Duration of study 2 years
measure: Adverse Events
timeFrame: Duration of study 2 years
measure: Fidelity to Intervention Protocol
timeFrame: Duration of study 2 years
measure: Feasibility of Outcome Measures (Participant)
timeFrame: Duration of study 2 years
measure: Feasibility of Outcome Measures (Assessor)
timeFrame: Duration of study 2 years
measure: Acceptability of Intervention
timeFrame: Duration of study 2 years
measure: Time taken to complete Outcome Measures
timeFrame: Duration of study 2 years
Secondary outcomes:
measure: Gait Outcome Assessment List
timeFrame: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
measure: 6 minute walk test
timeFrame: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
measure: 10 meter self-selected walking speed
timeFrame: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
measure: Modified timed up and go
timeFrame: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
measure: ankle and knee Range of motion
timeFrame: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
measure: Child Health Utilities Index CHU-9D
timeFrame: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
Other outcomes:
Locations:
city: Balrath
country: Ireland
facility: Enable Ireland Bangla Therapy Centre
state: Meath
Study officials:
affiliation: Royal College of Surgeons
name: Ailish Malone, PHD
role: PRINCIPAL_INVESTIGATOR
References: