Clinical trial NCT03678064: Use of the LOK® Robotic Gait Trainer in the Early Rehabilitation of Children After an Acquired Brain Injury (ABI)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury, Brain
Keywords: physical therapy
gait
pediatric rehabilitation
gross motor function
participation
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 7
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Gross Motor Function Measure (GMFM-66)
timeFrame: Baseline, 8 weeks
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Goal Attainment Scale (GAS)
timeFrame: Baseline, 8 weeks
measure: Gait speed (10 minute fastest walk test )
timeFrame: Baseline, 8 weeks
measure: The Pediatric Evaluation of Disability Inventory (PEDI-CAT)
timeFrame: Baseline, 8 weeks
measure: Movement Ability Self-efficacy Questionnaire (MASQ)
timeFrame: Baseline, week 8
Other outcomes:
measure: Feasibility indicator: Recruitment Rate
timeFrame: Monthly over 12 months through study completion
measure: Feasibility indicator: Retention Rate
timeFrame: Monthly over 12 months through study completion
measure: Feasibility indicator: Protocol Adherence
timeFrame: Monthly over 12 months through study completion
measure: Motor Learning Strategies Rating Instrument (MLSRI)
timeFrame: Week 2-3, Week 6-7
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Holland Bloorview Kids Rehabilitation Hospital
name: Ryan Hung, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Holland Bloorview Kids Rehabilitation Hospital
name: Virginia Wright, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.