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

NCT06454656 | Recruiting

• 1 other identifier: 23-163
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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. 1.Do the children/teens tolerate the therapy and feel that it is helpful?
2. 2.Do the parents/ families feel the therapy helps and is easy to commit to?
3. 3.Do the children/teens complete all their therapy sessions and assessments as planned?

Conditions

Cerebral Palsy; Walking, Difficulty; Spastic Diplegia; Hemiplegic Cerebral Palsy

Keywords

Motor Learning Theory; Neuroplasticity; Neurological Rehabilitation

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• Gait Outcome Assessment List

  baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years

• 6 minute walk test

  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

  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

  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

  baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

MOBILE OTHER

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

Also known as: MOtor learning Based Intervention for Lower Extremities

Intervention

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Enable Ireland Bangla Therapy Centre

Balrath, Meath, C15K0FV, Ireland

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Mobility Limitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ailish Malone, PHD

  Royal College of Surgeons

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitriona M O'Shaughnessy

CONTACT

0833128927; caitrionaoshaug22@rcsi.com

Ailish Malone, PHD

CONTACT

+3531-4022392; ailishmalone@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professional Doctorate Scholar

Model Details: Feasibility Study

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 12, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2025-10

Locations

IE (1)