Injury, Brain Clinical Trial
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
| NCT number | NCT03678064 |
| Other study ID # | 18-771 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 5, 2018 |
| Est. completion date | March 2019 |
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.
| Status | Recruiting |
| Enrollment | 7 |
| Est. completion date | March 2019 |
| Est. primary completion date | March 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 18 Years |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Holland Bloorview Kids Rehabilitation Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Holland Bloorview Kids Rehabilitation Hospital |
Canada,
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Feasibility indicator: Recruitment Rate | Recruitment rate (%) as measured by: # of participants enrolled / # of participants screened and eligible | Monthly over 12 months through study completion | |
| Other | Feasibility indicator: Retention Rate | Retention rate (%) as measured by: # of participants completing both baseline and follow-up assessment / total # of participants | Monthly over 12 months through study completion | |
| Other | Feasibility indicator: Protocol Adherence | Protocol adherence (%) as measured by: Number of sessions completed / 16 possible sessions | Monthly over 12 months through study completion | |
| Other | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Secondary | 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. | Baseline, 8 weeks | |
| Secondary | Gait speed (10 minute fastest walk test ) | Change from baseline in Gait Speed (10 minute fastest walk test) at week 8 | Baseline, 8 weeks | |
| Secondary | Observational Gait Scale | 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. |
Baseline, 8 weeks | |
| Secondary | The Pediatric Evaluation of Disability Inventory (PEDI-CAT) | Change from baseline in PEDI-CAT at week 8. | Baseline, 8 weeks | |
| Secondary | Movement Ability Self-efficacy Questionnaire (MASQ) | Change from baseline in MASQ at week 8 | Baseline, week 8 | |
| Secondary | Gait Kinematics (measured on the GaitRite evaluation system) | Change from baseline in gait kinematics as measured on the GaitRite evaluation system at week 8 | Baseline, week 8 |