Cerebral Palsy, Hemiplegic Cerebral Palsy, Spastic Diplegia, Walking, Difficulty
Conditions
Keywords
Motor Learning Theory, Neuroplasticity, Neurological Rehabilitation
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.
Interventions
OTHERMOBILE
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
Sponsors
Royal College of Surgeons, Ireland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Feasibility Study
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | rolling recruitment over 1.5 years | Percentage of eligible numbers recruited |
| Adherence to Intervention | Duration of study 2 years | Percentage of total hours practiced/ planned dose (30 hours) |
| Retention | Duration of study 2 years | Percentage of recruited participants at final follow up |
| Adverse Events | Duration of study 2 years | Measured as Yes or No with description |
| Fidelity to Intervention Protocol | Duration of study 2 years | Checklist to measure extent of motor learning principles included in sessions |
| Feasibility of Outcome Measures (Participant) | Duration of study 2 years | Participant experience of outcomes captured by semi-structured interviews. |
| Feasibility of Outcome Measures (Assessor) | Duration of study 2 years | Assessor experience of outcomes captured by semi-structured interview. |
| Acceptability of Intervention | 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 | Duration of study 2 years | Measured in Minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Outcome Assessment List | 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. |
| 6 minute walk test | 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. |
| 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 | habitual walking speed selected as it correlates well with habitual physical activities. |
| 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 | tests balance and basic mobility in children with physical disabilities and has been validated for use in CP |
| 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 | CPIP measures of ankle DF and popliteal angle |
| Child Health Utilities Index CHU-9D | 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. |
Countries
Ireland
Contacts
CONTACTCaitriona M O'Shaughnessy
CONTACTAilish Malone, PHD
PRINCIPAL_INVESTIGATORAilish Malone, PHD
Royal College of Surgeons
Outcome results
None listed