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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lokomat | Experimental | 16 sessions total. Provided by study PT twice weekly for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lokomat | Device | 16 sessions total. Provided by study PT twice weekly for a period of 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gross Motor Function Measure (GMFM-66) | Change from baseline in motor function on Gross Motor Function Measure (GMFM-66) at week 8 | Baseline, 8 weeks |
| Canadian Occupational Performance Measure (COPM) | Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure at week 8 | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Goal Attainment Scale (GAS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility indicator: Recruitment Rate | Recruitment rate (%) as measured by: # of participants enrolled / # of participants screened and eligible | Monthly over 12 months through study completion |
| Feasibility indicator: Retention Rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Hung, MD, MSc | Holland Bloorview Kids Rehabilitation Hospital | Principal Investigator |
| Virginia Wright, PT, PhD | Holland Bloorview Kids Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holland Bloorview Kids Rehabilitation Hospital | Toronto | Ontario | M4G2X3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25915458 | Background | Beretta E, Romei M, Molteni E, Avantaggiato P, Strazzer S. Combined robotic-aided gait training and physical therapy improve functional abilities and hip kinematics during gait in children and adolescents with acquired brain injury. Brain Inj. 2015;29(7-8):955-62. doi: 10.3109/02699052.2015.1005130. Epub 2015 Apr 27. | |
| 21415229 |
| Label | URL |
|---|---|
| Beretta E, Storm FA, Strazzer S, Frascarelli F, Petrarca M, Colazza A, Cordone G, Biffi E, Morganti R, Maghini C, Piccinini L, Reni G, Castelli E. Effect of Robot-Assisted Gait Training in a Large Population of Children With Motor Impairment Due to Cereb | View source |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| Baseline, 8 weeks |
| Gait speed (10 minute fastest walk test ) | Change from baseline in Gait Speed (10 minute fastest walk test) at week 8 | Baseline, 8 weeks |
| The Pediatric Evaluation of Disability Inventory (PEDI-CAT) | Change from baseline in PEDI-CAT at week 8. | Baseline, 8 weeks |
| Movement Ability Self-efficacy Questionnaire (MASQ) | Change from baseline in MASQ at week 8 | Baseline, week 8 |
Retention rate (%) as measured by: # of participants completing both baseline and follow-up assessment / total # of participants
| Monthly over 12 months through study completion |
| Feasibility indicator: Protocol Adherence | Protocol adherence (%) as measured by: Number of sessions completed / 16 possible sessions | Monthly over 12 months through study completion |
| Motor Learning Strategies Rating Instrument (MLSRI) | Compare motor learning strategy (MLS) use in LOK and PT to explore how LOK use may affect motor skill acquisition post-ABI. | Week 2-3, Week 6-7 |
| Levac D, Missiuna C, Wishart L, Dematteo C, Wright V. Documenting the content of physical therapy for children with acquired brain injury: development and validation of the motor learning strategy rating instrument. Phys Ther. 2011 May;91(5):689-99. doi: 10.2522/ptj.20100415. Epub 2011 Mar 17. |
| 22574628 | Background | Kamath T, Pfeifer M, Banerjee-Guenette P, Hunter T, Ito J, Salbach NM, Wright V, Levac D. Reliability of the motor learning strategy rating instrument for children and youth with acquired brain injury. Phys Occup Ther Pediatr. 2012 Aug;32(3):288-305. doi: 10.3109/01942638.2012.672551. Epub 2012 May 11. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |