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Injury, BrainNCT03678064

Use of the LOK® Robotic Gait Trainer in the Early Rehabilitation of Children After an Acquired Brain Injury (ABI)

A study testing Lokomat in people with Injury, Brain, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Injury, Brain
What is being tested?
Lokomat
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteCanada
Study dates
5 Jun 2018to 15 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Holland Bloorview Kids Rehabilitation Hospital

    Toronto, Ontario, M4G2X3

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Injury, Brain
Being tested
Lokomat
Keywords
physical therapy, gait, pediatric rehabilitation, gross motor function, participation
Medical subject headings
Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LokomatDevice

    16 sessions total. Provided by study PT twice weekly for a period of 8 weeks

Study groups in NCT03678064
Study groupRoleWhat they receive
LokomatExperimental16 sessions total. Provided by study PT twice weekly for 8 weeks.
Receives: Device: Lokomat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gross Motor Function Measure (GMFM-66)

    Change from baseline in motor function on Gross Motor Function Measure (GMFM-66) at week 8

    Measured: Baseline, 8 weeks

  2. 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

    Measured: Baseline, 8 weeks

Secondary outcomes (4)

  1. 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.

    Measured: Baseline, 8 weeks

  2. Gait speed (10 minute fastest walk test )

    Change from baseline in Gait Speed (10 minute fastest walk test) at week 8

    Measured: Baseline, 8 weeks

  3. The Pediatric Evaluation of Disability Inventory (PEDI-CAT)

    Change from baseline in PEDI-CAT at week 8.

    Measured: Baseline, 8 weeks

  4. Movement Ability Self-efficacy Questionnaire (MASQ)

    Change from baseline in MASQ at week 8

    Measured: Baseline, week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2018
  2. Study start5 Jun 2018
  3. Primary completion15 Mar 2020
  4. Study completion15 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03678064
Sponsor's protocol ID
18-771
Status last verified
Sep 2024
First submitted
3 May 2018
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25915458

  • 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.

    PubMed 21415229

  • 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.

    PubMed 22574628

Questions about this trial

What is this clinical trial studying?

A study testing Lokomat in people with Injury, Brain, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gross Motor Function Measure (GMFM-66) (time frame: Baseline, 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03678064, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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