Injury, Brain
Conditions
Keywords
physical therapy, gait, pediatric rehabilitation, gross motor function, participation
Brief summary
After an acquired brain injury (ABI), children often require extensive physiotherapy (PT) to help them relearn to walk. There is promising evidence in pediatric neuro-motor conditions of the possibility for brain activation pattern changes in response to repetitive, task-oriented functional gait training. Robotic-assisted gait training devices such as the Lokomat (LOK) allow this type of intensive walking retraining. The aim of this study is to assess the safety, feasibility and outcome possibilities linked to a LOK intervention given as 2 of the child's 4 PT weekly sessions over 8-weeks in the early stages of rehabilitation after an ABI.
Detailed description
This is Phase 3 of our three- year ABI Lokomat study . Phase 1 was conducted in 2016-2017 and was a single-group pre- and post-test feasibility study of the Lokomat in pediatric ABI inpatients and daypatients in which we enrolled 9 patient participants. The co-primary outcome measures for this first phase were the Gross Motor Function Measure (GMFM), Canadian Occupational Performance Measure (COPM) . Other measures of function (PEDI-CAT), gait (6 minute walk test and Timed up and GO) and individualized goals (Goal Attainment Scaling) were included. Study feasibility was evaluated via indicators such as enrollment, number of sessions completed, drop out rate, and adverse events. Phase 2 was conducted in 2017-2018 using the same core outcome set, and added a qualitative study component with child and parent and physiotherapist interviews for their perspective on the Lokomat experience and associated outcomes. The investigators enrolled 6 patient participants (quantitative and qualitative) and their caregivers (qualitative). Phase 3 will aim to enroll 6 to 8 more children to strengthen effect size estimates for the GMFM and COPM in particular (proposed co-primary outcome measures for future randomized controlled trial). The investigators will also add in a 10 metre fast walk test to allow children with lower walking tolerance to have a gait measure, and pilot a measure of children's self-efficacy that the investigators will design for this study. Finally, the investigators will take a close look at motor learning strategies (MLS) used by the PTs in both LOK and PT sessions using the validated Motor Learning Strategies Rating Instrument (MLSRI) to begin to get a profile of comparative MLS use in gym-based PT and LOK sessions. The investigators will continue to study feasibility and add to the data from the first 2 phases the ABI LOK project.
Interventions
DEVICELokomat
16 sessions total. Provided by study PT twice weekly for a period of 8 weeks
Sponsors
Holland Bloorview Kids Rehabilitation Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Be an inpatient or daypatient in the Brain Injury Rehabilitation program at Holland Bloorview Kids Rehabilitation Hospital with moderate or severe ABI * Be Gross Motor Function Classification System-equivalent III or IV with primary gait goals * Have any limb distribution of involvement (spasticity or hypotonicity). The physiotherapist (PT) and Lokomat (LOK) sessions (both about 45-minutes in length) will employ a motor learning strategies approach. * Have a femur length at least 21 cm (to fit robotic legs) and height no greater than 6' 3 to fit LOK frame * Be no more than 12 months post-ABI (i.e., still active rehab stage), and * Be expected by clinical team (confirmed by child's physician) to have at least 8 more weeks of inpatient or daypatient rehab * Be able to follow Gross Motor Function Measure instructions and participate in \> 45 minutes of active PT (as judged by the child's PT) * Be able to reliably signal pain and discomfort using verbal or nonverbal signals (as assessed at the screening assessment) for LOK operation safety reasons.
Exclusion criteria
* A seizure in the last 12 months, * Inability to tolerate full weightbearing * A knee flexion contracture \> 20 degrees, knee valgus \>40 degrees, hip subluxation \> 40% migration percentage * Excessive tone or ataxic or dyskinetic movements may be an exclusion (would be determined at LOK set-up confirmation visit).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Measure (GMFM-66) | Baseline, 8 weeks | Change from baseline in motor function on Gross Motor Function Measure (GMFM-66) at week 8 |
| Canadian Occupational Performance Measure (COPM) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait speed (10 minute fastest walk test ) | Baseline, 8 weeks | Change from baseline in Gait Speed (10 minute fastest walk test) at week 8 |
| Goal Attainment Scale (GAS) | 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. |
| The Pediatric Evaluation of Disability Inventory (PEDI-CAT) | Baseline, 8 weeks | Change from baseline in PEDI-CAT at week 8. |
| Movement Ability Self-efficacy Questionnaire (MASQ) | Baseline, week 8 | Change from baseline in MASQ at week 8 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility indicator: Protocol Adherence | 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) | 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. |
| Feasibility indicator: Retention Rate | 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: Recruitment Rate | Monthly over 12 months through study completion | Recruitment rate (%) as measured by: # of participants enrolled / # of participants screened and eligible |
Countries
Canada
Outcome results
None listed