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NCT Number: NCT06454656

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Hemiplegic Cerebral Palsy Mobility Limitation Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Spastic Diplegia Walking, Difficulty

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: MOtor learning Based Intervention for Lower Extremities

Primary outcomes

  1. Recruitment Rate

    Time frame: rolling recruitment over 1.5 years

    Percentage of eligible numbers recruited

  2. Adherence to Intervention

    Time frame: Duration of study 2 years

    Percentage of total hours practiced/ planned dose (30 hours)

  3. Retention

    Time frame: Duration of study 2 years

    Percentage of recruited participants at final follow up

  4. Adverse Events

    Time frame: Duration of study 2 years

    Measured as Yes or No with description

  5. Fidelity to Intervention Protocol

    Time frame: Duration of study 2 years

    Checklist to measure extent of motor learning principles included in sessions

  6. Feasibility of Outcome Measures (Participant)

    Time frame: Duration of study 2 years

    Participant experience of outcomes captured by semi-structured interviews.

  7. Feasibility of Outcome Measures (Assessor)

    Time frame: Duration of study 2 years

    Assessor experience of outcomes captured by semi-structured interview.

  8. Acceptability of Intervention

    Time frame: Duration of study 2 years

    Semi-structured interviews of participants and parents to capture acceptability of intervention using Framework of acceptability

  9. Time taken to complete Outcome Measures

    Time frame: Duration of study 2 years

    Measured in Minutes

Secondary outcomes

  1. Gait Outcome Assessment List

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

    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.

  2. 6 minute walk test

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

    This is a measure of gait endurance and has been validated for use in CP. Gait speed will also be calculated using this measure.

  3. 10 meter self-selected walking speed

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

    habitual walking speed selected as it correlates well with habitual physical activities.

  4. Modified timed up and go

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

    tests balance and basic mobility in children with physical disabilities and has been validated for use in CP

  5. ankle and knee Range of motion

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

    CPIP measures of ankle DF and popliteal angle

  6. Child Health Utilities Index CHU-9D

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

    self-report measure that can calculate quality adjusted life years to measure quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Ailish Malone, PHD

CONTACT

[email protected]

+3531-4022392

Caitriona M O'Shaughnessy

CONTACT

[email protected]

0833128927

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Registry information

Official study title

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

Acronym: MOBILE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 12, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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