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Robotic-assisted gait training device

Lokomat for Traumatic Brain Injury

N/A
Waitlist Available
Led By Virginia Wright, PT, PhD
Research Sponsored by Holland Bloorview Kids Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly over 12 months through study completion
Awards & highlights

Study 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.

Eligible Conditions
  • Traumatic Brain Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly over 12 months through study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly over 12 months through study completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Canadian Occupational Performance Measure (COPM)
Gross Motor Function Measure (GMFM-66)
Secondary outcome measures
Gait Kinematics (measured on the GaitRite evaluation system)
Gait speed (10 minute fastest walk test )
Goal Attainment Scale (GAS)
+3 more
Other outcome measures
Feasibility indicator: Protocol Adherence
Feasibility indicator: Recruitment Rate
Feasibility indicator: Retention Rate
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: LokomatExperimental Treatment1 Intervention
16 sessions total. Provided by study PT twice weekly for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lokomat
2012
Completed Phase 2
~280

Find a Location

Who is running the clinical trial?

Holland Bloorview Kids Rehabilitation HospitalLead Sponsor
67 Previous Clinical Trials
14,067 Total Patients Enrolled
Virginia Wright, PT, PhDPrincipal InvestigatorHolland Bloorview Kids Rehabilitation Hospital
1 Previous Clinical Trials
32 Total Patients Enrolled
Ryan Hung, MD, MScPrincipal InvestigatorHolland Bloorview Kids Rehabilitation Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Use of the LOK® Robotic Gait Trainer in the Early Rehabilitation of Children After an Acquired Brain Injury (ABI)
2018. "Use of the LOK® Robotic Gait Trainer in the Early Rehabilitation of Children After an Acquired Brain Injury (ABI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03678064.
All > Brain Injury
~1 spots leftby Apr 2025
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