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Clinical Trials/NCT02584491
NCT02584491
Completed
N/A

Linking Neuroplasticity With the Outcomes of Motor Learning Based Interventions: Multi-modal Evaluation of Walking-based Training in Children and Youth With Cerebral Palsy

Holland Bloorview Kids Rehabilitation Hospital1 site in 1 country9 target enrollmentJuly 2015
ConditionsCerebral Palsy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Enrollment
9
Locations
1
Primary Endpoint
Change from baseline in functional activity in lower-limb related cortical areas, assessed using functional MRI (fMRI)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
December 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 7 to17 years inclusive;
  • GMFCS Level I or II;
  • Able to follow testing and motor imagery instructions;
  • Able to actively participate in a minimum of 45 minutes of physical activity;
  • Able to independently dorsiflex both ankles;
  • Able to commit to attendance of sessions two to three times weekly for six weeks.

Exclusion Criteria

  • Orthopaedic surgery within the last 9 months (muscle) or 12 months (bone);
  • Botulinum toxin-A (BTX-A) injections to lower limb in the last 4 months;
  • Inability to discontinue BTX-A for period of 12 weeks (during trial) due to concerns about ROM or pain;
  • Severe spasticity (may be a contraindication for neuroimaging procedures);
  • Seizure disorder (if not fully controlled by medication for the 12 months);
  • Not prepared or unable to discontinue a regular lower limb therapy intervention during the course of the trial;
  • Involved in another intervention study;
  • Standard MRI contraindications (e.g., metal implants such as cochlear implant, claustrophobia).

Outcomes

Primary Outcomes

Change from baseline in functional activity in lower-limb related cortical areas, assessed using functional MRI (fMRI)

Time Frame: 7 days pre/7 days post training intervention

Change from baseline in advanced motor skills on the Challenge Module

Time Frame: 7 days pre/7 days post/4-months post training intervention

The Challenge Module is a new published measure of advanced motor skills.

Secondary Outcomes

  • Change from baseline in resting state activity, assessed using resting state fMRI(7 days pre/7 days post training intervention)
  • Mental chronometry: walking(7 days pre/7days post/4-months post intervention)
  • Change from baseline in walking activity, assessed using a StepWatch accelerometer(7 days pre/7days post/4-months post training intervention)
  • Change from baseline in walk speed on the Six-minute walk test(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(7 days pre/7days post/4-months post training intervention)
  • Motor learning as evaluated using retention and transfer tests(Week 2, 4, 6)
  • Change from baseline in microstructure of brain, assessed using diffusion tensor imaging (DTI)(7 days pre/7 days post training intervention)
  • Change from baseline in Physical Activity self-efficacy(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)(Week 2, 4, 6)
  • Change from baseline in lower-limb proprioception(7 days pre/7days post/4-months post intervention)
  • Change from baseline in gait kinematics as measured using an electronic walkway(7 days pre/7days post/4-months post training intervention)
  • Change from baseline in gait kinetics/kinematics as measured using 3D motion capture system(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)(7 days pre/7days post/4-months post training intervention)
  • Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS)(7 days pre/7days post/4-months post training intervention)

Study Sites (1)

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