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

NCT03678064 | Completed DMC

• 1 other identifier: 18-771
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Injury, Brain

Keywords

physical therapy; gait; pediatric rehabilitation; gross motor function; participation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Goal Attainment Scale (GAS)

  Baseline, 8 weeks

• Gait speed (10 minute fastest walk test )

  Baseline, 8 weeks

• The Pediatric Evaluation of Disability Inventory (PEDI-CAT)

  Baseline, 8 weeks

• Movement Ability Self-efficacy Questionnaire (MASQ)

  Baseline, week 8

Other Outcomes (4)

• Feasibility indicator: Recruitment Rate

  Monthly over 12 months through study completion

• Feasibility indicator: Retention Rate

  Monthly over 12 months through study completion

• Feasibility indicator: Protocol Adherence

  Monthly over 12 months through study completion

Study Arms (1)

Lokomat

EXPERIMENTAL

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

Device: Lokomat

Interventions

Lokomat DEVICE

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

Lokomat

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G2X3, Canada

Location

Related Publications (3)

• 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.

  PMID: 25915458 BACKGROUND

• 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.

  PMID: 21415229 BACKGROUND

• 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.

  PMID: 22574628 BACKGROUND

Related Links

• Beretta E, Storm FA, Strazzer S, Frascarelli F, Petrarca M, Colazza A, Cordone G, Biffi E, Morganti R, Maghini C, Piccinini L, Reni G, Castelli E. Effect of Robot-Assisted Gait Training in a Large Population of Children With Motor Impairment Due to Cereb

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ryan Hung, MD, MSc

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

• Virginia Wright, PT, PhD

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: September 19, 2018
• Study Start: June 5, 2018
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)