Use of the LOK® Robotic Gait Trainer in the Early Rehabilitation of Children After an Acquired Brain Injury (ABI)
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|ClinicalTrials.gov Identifier: NCT03678064|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Injury, Brain||Device: Lokomat||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Use of the LOK® Robotic Gait Trainer in the Early Rehabilitation of Children After an Acquired Brain Injury (ABI): A Feasibility Study - Part III|
|Actual Study Start Date :||June 5, 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
16 sessions total. Provided by study PT twice weekly for 8 weeks.
16 sessions total. Provided by study PT twice weekly for a period of 8 weeks
- Gross Motor Function Measure (GMFM-66) [ Time Frame: Baseline, 8 weeks ]Change from baseline in motor function on Gross Motor Function Measure (GMFM-66) at week 8
- Canadian Occupational Performance Measure (COPM) [ Time Frame: Baseline, 8 weeks ]Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure at week 8
- Goal Attainment Scale (GAS) [ Time Frame: Baseline, 8 weeks ]Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS) at week 8. Three to five individualized walking-based activity/participation goals are set with child/parent/treating PT at baseline. Goal achievement level (score of -2 to+2) evaluated by treating PT with child/parent input at post-intervention assessment. GAS outcome (achievement) is measured by a standardized T-score that is a summary score(calculated from individual goal -2 to +2 scores) for the child's set of goals . Goal accomplishment at the targeted level (averaged across the goal set) is reflected by a T score = 50.0 + 5 with range of scores from ~ 25 to 85.
- Gait speed (10 minute fastest walk test ) [ Time Frame: Baseline, 8 weeks ]Change from baseline in Gait Speed (10 minute fastest walk test) at week 8
- Observational Gait Scale [ Time Frame: Baseline, 8 weeks ]
Change from baseline in Gait quality as measured on an observational gait scale at week 8.
Gait pattern evaluated via an observational 25-item scale (Total score /100 with higher scores indicating better pattern) that was constructed and validated in cerebral palsy by CoPI Wright at the research facility. Rating is from video of child's walking along a 7 metre distance.
- The Pediatric Evaluation of Disability Inventory (PEDI-CAT) [ Time Frame: Baseline, 8 weeks ]Change from baseline in PEDI-CAT at week 8.
- Movement Ability Self-efficacy Questionnaire (MASQ) [ Time Frame: Baseline, week 8 ]Change from baseline in MASQ at week 8
- Gait Kinematics (measured on the GaitRite evaluation system) [ Time Frame: Baseline, week 8 ]Change from baseline in gait kinematics as measured on the GaitRite evaluation system at week 8
- Feasibility indicator: Recruitment Rate [ Time Frame: Monthly over 12 months through study completion ]Recruitment rate (%) as measured by: # of participants enrolled / # of participants screened and eligible
- Feasibility indicator: Retention Rate [ Time Frame: Monthly over 12 months through study completion ]Retention rate (%) as measured by: # of participants completing both baseline and follow-up assessment / total # of participants
- Feasibility indicator: Protocol Adherence [ Time Frame: Monthly over 12 months through study completion ]Protocol adherence (%) as measured by: Number of sessions completed / 16 possible sessions
- Motor Learning Strategies Rating Instrument (MLSRI) [ Time Frame: Week 2-3, Week 6-7 ]Compare motor learning strategy (MLS) use in LOK and PT to explore how LOK use may affect motor skill acquisition post-ABI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678064
|Contact: Ryan Hung, MD, MScemail@example.com|
|Contact: Virginia Wright, PT, PhD||4164256220 ext firstname.lastname@example.org|
|Holland Bloorview Kids Rehabilitation Hospital||Recruiting|
|Toronto, Ontario, Canada, M4G2X3|
|Contact: Ryan Hung, MD 4167536019 email@example.com|
|Contact: Virginia Wright, PhD 4164256220 ext 3824 firstname.lastname@example.org|
|Principal Investigator:||Ryan Hung, MD, MSc||Holland Bloorview Kids Rehabilitation Hospital|
|Principal Investigator:||Virginia Wright, PT, PhD||Holland Bloorview Kids Rehabilitation Hospital|