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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
Sponsor:
Information provided by (Responsible Party):
Holland Bloorview Kids Rehabilitation Hospital

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.

Condition or disease Intervention/treatment Phase
Injury, Brain Device: Lokomat Not Applicable

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 an observational gait scale to measure potential changes in gait pattern/quality which investigators have noted in the first 2 years of the study, 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.

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Lokomat
16 sessions total. Provided by study PT twice weekly for 8 weeks.
Device: Lokomat
16 sessions total. Provided by study PT twice weekly for a period of 8 weeks




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


  4. The Pediatric Evaluation of Disability Inventory (PEDI-CAT) [ Time Frame: Baseline, 8 weeks ]
    Change from baseline in PEDI-CAT at week 8.

  5. Movement Ability Self-efficacy Questionnaire (MASQ) [ Time Frame: Baseline, week 8 ]
    Change from baseline in MASQ at week 8

  6. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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.



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Contacts
Contact: Ryan Hung, MD, MSc 4167536019 rhung@hollandbloorview.ca
Contact: Virginia Wright, PT, PhD 4164256220 ext 3824 vwright@hollandbloorview.ca

Locations
Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital Recruiting
Toronto, Ontario, Canada, M4G2X3
Contact: Ryan Hung, MD    4167536019    rhung@hollandbloorview.ca   
Contact: Virginia Wright, PhD    4164256220 ext 3824    vwright@hollandbloorview.ca   
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Investigators
Principal Investigator: Ryan Hung, MD, MSc Holland Bloorview Kids Rehabilitation Hospital
Principal Investigator: Virginia Wright, PT, PhD Holland Bloorview Kids Rehabilitation Hospital

Publications:
Responsible Party: Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03678064     History of Changes
Other Study ID Numbers: 18-771
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Holland Bloorview Kids Rehabilitation Hospital:
physical therapy
gait
pediatric rehabilitation
gross motor function
participation

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System