Cerebral PalsyMOBILENCT06454656
A Motor Learning Intervention to Target Walking Performance in Ambulant Children With Cerebral Palsy
A study testing MOBILE in people with Cerebral Palsy and Walking, Difficulty, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cerebral Palsy, Walking, Difficulty, Spastic Diplegia
- What is being tested?
- MOBILE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIreland
- Study dates
- 12 Aug 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Enable Ireland Bangla Therapy Centre
Balrath, Meath, C15K0FV
Caitriona M O'Shaughnessy, BSc, 0833128927, caitrionaoshaug22@rcsi.com
Lorna Gough, BA Hons, 01 8240696, lgough@enableireland.ie
About this study
Official title: 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:
Read more
- Do the children/teens tolerate the therapy and feel that it is helpful?
- Do the parents/ families feel the therapy helps and is easy to commit to?
- 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.
Read the 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.
- Being tested
- MOBILE
- Keywords
- Motor Learning Theory, Neuroplasticity, Neurological Rehabilitation
- Medical subject headings
- Cerebral Palsy, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOBILEOther
Also called MOtor learning Based Intervention for Lower Extremities
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MOBILE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Percentage of eligible numbers recruited
Measured: rolling recruitment over 1.5 years
Adherence to Intervention
Percentage of total hours practiced/ planned dose (30 hours)
Measured: Duration of study 2 years
Retention
Percentage of recruited participants at final follow up
Measured: Duration of study 2 years
Adverse Events
Measured as Yes or No with description
Measured: Duration of study 2 years
Fidelity to Intervention Protocol
Checklist to measure extent of motor learning principles included in sessions
Measured: Duration of study 2 years
Feasibility of Outcome Measures (Participant)
Participant experience of outcomes captured by semi-structured interviews.
Measured: Duration of study 2 years
Feasibility of Outcome Measures (Assessor)
Assessor experience of outcomes captured by semi-structured interview.
Measured: Duration of study 2 years
Acceptability of Intervention
Semi-structured interviews of participants and parents to capture acceptability of intervention using Framework of acceptability
Measured: Duration of study 2 years
Time taken to complete Outcome Measures
Measured in Minutes
Measured: Duration of study 2 years
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
habitual walking speed selected as it correlates well with habitual physical activities.
Measured: 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
Measured: 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
Measured: 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.
Measured: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start12 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility Study
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catriona O'Shaughnessy, Royal College of Surgeons, Ireland
- Investigators
- Ailish Malone, PHD, Principal investigator, Royal College of Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454656
- Sponsor's protocol ID
- 23-163
- Acronym
- MOBILE
- Status last verified
- Oct 2025
- First submitted
- 24 May 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A "MOtor Learning Based Intervention for Lower Extremities (MOBILE)" to Target Walking Performance in Ambulant Children With Cerebral Palsy: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06454656
- Acronym / sponsor ID
- MOBILE / 23-163
- Keywords
- Motor Learning Theory, Neuroplasticity, Neurological Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do the children/teens tolerate the therapy and feel that it is helpful?
- Do the parents/ families feel the therapy helps and is easy to commit to?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility Study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: MOBILEParticipants 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOBILEAlso: MOtor learning Based Intervention for Lower ExtremitiesIntensive 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 | Intervention |
Primary outcome
Recruitment Rate
Time frame: rolling recruitment over 1.5 years
Percentage of eligible numbers recruited
Adherence to Intervention
Time frame: Duration of study 2 years
Percentage of total hours practiced/ planned dose (30 hours)
Retention
Time frame: Duration of study 2 years
Percentage of recruited participants at final follow up
Adverse Events
Time frame: Duration of study 2 years
Measured as Yes or No with description
Fidelity to Intervention Protocol
Time frame: Duration of study 2 years
Checklist to measure extent of motor learning principles included in sessions
Feasibility of Outcome Measures (Participant)
Time frame: Duration of study 2 years
Participant experience of outcomes captured by semi-structured interviews.
Feasibility of Outcome Measures (Assessor)
Time frame: Duration of study 2 years
Assessor experience of outcomes captured by semi-structured interview.
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
Time taken to complete Outcome Measures
Time frame: Duration of study 2 years
Measured in Minutes
6 secondary outcomes
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ailish Malone, PHD principal investigator
Royal College of Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOBILE in people with Cerebral Palsy and Walking, Difficulty, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caitriona M O'Shaughnessy (0833128927, caitrionaoshaug22@rcsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: rolling recruitment over 1.5 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.