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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
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The purpose of this study is to determine the associations between changes in neural activity and structure, advanced gross motor skills, gait characteristics, and physical activity participation following a gait-related intervention that is based on motor learning principles for ambulatory children and youth with hemiplegic and diplegic cerebral palsy. The investigators' hypothesis is that in conjunction with a program of motor learning based training, functional neuroplastic changes in the involved motor areas will be strongly associated with changes in gait and advanced gross motor skills, moderately associated with physical activity based participation changes, and will have a fair association with structural neuroplastic change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional gait-related training | Experimental | 16 session, 6-week intensive functional gait-related training intervention based on motor learning principles that includes a motor imagery practice component. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional gait-related training | Behavioral | The motor learning (ML)-based functional gait-related training program is designed to improve advanced gross motor skills and athleticism. It will involve 45-min sessions twice to three times weekly over 6 weeks for a total of 16 active sessions. A maximum of 7 weeks will be permitted. Each session will consist of 35-min of active training along with a 10-min active warm-up/cool-down that incorporates ML. Scheduling flexibility will promote adherence, with a minimum one day between sessions to provide opportunity for rest. Children will be given a 3- to 5-min mental motor imagery script to practice on days when they do not have active training sessions. The total number of sessions (combined active/imagery) will be five per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in functional activity in lower-limb related cortical areas, assessed using functional MRI (fMRI) | 7 days pre/7 days post training intervention | |
| Change from baseline in advanced motor skills on the Challenge Module | The Challenge Module is a new published measure of advanced motor skills. | 7 days pre/7 days post/4-months post training intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in resting state activity, assessed using resting state fMRI | 7 days pre/7 days post training intervention | |
| Change from baseline in microstructure of brain, assessed using diffusion tensor imaging (DTI) | 7 days pre/7 days post training intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Body Pain | Use of FACES pain scale and body diagrams to show areas of pain (musculoskeletal and other) | Completed 2 minutes before and 2 minutes after each intervention session |
| Intervention enjoyment, assessed using a modified version of the Physical Activity Enjoyment Scale (PACES) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holland Bloorview Kids Rehabilitation Hospital | Toronto | Ontario | M4G 1R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36524254 | Derived | Hilderley AJ, Wright FV, Taylor MJ, Chen JL, Fehlings D. Functional Neuroplasticity and Motor Skill Change Following Gross Motor Interventions for Children With Diplegic Cerebral Palsy. Neurorehabil Neural Repair. 2023 Jan;37(1):16-26. doi: 10.1177/15459683221143503. Epub 2022 Dec 15. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Change from baseline in Physical Activity self-efficacy | Participant-report measure of Task efficacy and Barrier efficacy for physical activity. | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in walking activity, assessed using a StepWatch accelerometer | Participants will wear the StepWatch for 5 days. | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in gait kinematics as measured using an electronic walkway | Time/distance parameters of footsteps via GAITRite system. | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in gait kinetics/kinematics as measured using 3D motion capture system | Whole body gait analysis via Vicon motion capture and Bertec force plates. | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in physical activity participation, as measured using the Participation and Environment Measure for Children/Youth (PEM-CY) | Parent-report measure of participation in the home, school and community, as well as environmental factors within each setting. | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in walk speed on the Six-minute walk test | Standardized 6 minute walk test (with shoes, orthoses, walking devices as required) to determine distance covered (capability measure). Well-validated in pediatric CP. | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure | Three to five individualized walking-based activity/participation set at baseline with assessor and child/parent, and re-evaluated by child/parent at post-intervention assessments | 7 days pre/7days post/4-months post training intervention |
| Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS) | Three to five individualized walking-based activity/participation set at baseline with assessor and child/parent, and re-evaluated by child/parent at post-intervention assessments | 7 days pre/7days post/4-months post training intervention |
| Motor learning content of interventions, as assessed using the Motor Learning Strategy Rating Instrument (MLSRI) | The MLSRI is used to assess the extent to which motor learning strategies are used within an intervention session | Week 2, 4, 6 |
| Motor learning as evaluated using retention and transfer tests | Individualized skills will be identified to practice at every session (retention) and only at sessions 5/10/15 (transfer) to evaluate motor learning | Week 2, 4, 6 |
| Change from baseline in lower-limb proprioception | Lower limb joint-sense position and kinesthesia will be assessed using a semi-goniometer (protocol modified from Wingert et al, 2009) | 7 days pre/7days post/4-months post intervention |
| Mental chronometry: walking | Participants will be timed while walking a 10-meter distance, and then timed while imagining walking the same distance. | 7 days pre/7days post/4-months post intervention |
Participants' enjoyment of the intervention sessions will be assessed every 2 weeks, with the questionnaire administered by a research team member not involved in intervention delivery. |
| Week 2, 4, 6 |
| Rating of exertion, assessed using Pictoral Children's Effort Rating Table (PCERT) | Children will be asked to complete PCERT at mid-point of each session, and 2 minutes before session completion | Completed at 22 minutes (mid-point) and at 43-minutes (2-minutes before end) of each intervention session |
| Heart Rate | Heart rate will be monitored by treating kinesiologist. | Assessed at 4 time points per session: 1 min before start of session, at 22 minutes (mid-point), at 43-minutes (2-min before end), and at 45-minutes (end) of each session. |