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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Spastic Diplegia; Hemiplegic Cerebral Palsy; Walking, Difficulty
• Intervention / Treatment: Other: MOBILE

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.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caitriona M O'Shaughnessy; Phone Number: 0833128927; Email: caitrionaoshaug22@rcsi.com
• Study Contact Backup: Name: Ailish Malone, PHD; Phone Number: +3531-4022392; Email: ailishmalone@rcsi.ie

Study Locations

• Ireland
  • Meath
    • Balrath, Meath, Ireland, C15K0FV
      • Recruiting
      • Enable Ireland Bangla Therapy Centre
      • Contact: Caitriona M O'Shaughnessy, BSc; Phone Number: 0833128927; Email: caitrionaoshaug22@rcsi.com
      • Contact: Lorna Gough, BA Hons; Phone Number: 01 8240696; Email: lgough@enableireland.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Participants will undergo 30 hours of therapy over 6 weeks in format of their choosing. A minimum of 24 hours must be completed in clinic with the rest made up of home program.

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; Other Names: MOtor learning Based Intervention for Lower Extremities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	Percentage of eligible numbers recruited	rolling recruitment over 1.5 years
Adherence to Intervention	Percentage of total hours practiced/ planned dose (30 hours)	Duration of study 2 years
Retention	Percentage of recruited participants at final follow up	Duration of study 2 years
Adverse Events	Measured as Yes or No with description	Duration of study 2 years
Fidelity to Intervention Protocol	Checklist to measure extent of motor learning principles included in sessions	Duration of study 2 years
Feasibility of Outcome Measures (Participant)	Participant experience of outcomes captured by semi-structured interviews.	Duration of study 2 years
Feasibility of Outcome Measures (Assessor)	Assessor experience of outcomes captured by semi-structured interview.	Duration of study 2 years
Acceptability of Intervention	Semi-structured interviews of participants and parents to capture acceptability of intervention using Framework of acceptability	Duration of study 2 years
Time taken to complete Outcome Measures	Measured in Minutes	Duration of study 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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.	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.	baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Investigators: Principal Investigator: Ailish Malone, PHD, Royal College of Surgeons

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Neuroplasticity; Neurological Rehabilitation; Motor Learning Theory
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebral Palsy; Mobility Limitation
• Other Study ID Numbers: 23-163

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No