Exoskeleton-assisted Training to Accelerate Walking Recovery Early After Stroke: the TARGET Phase II Study

NCT03727919 | Completed

• 2 other identifiers: JS-21S64819N
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief Summary

Phase II: Investigating the effects of additional robot-assisted gait training either initiated early (2 weeks post-stroke) or delayed (8 weeks post-stroke) after stroke onset.

Conditions

Stroke; Paresis; Gait, Hemiplegic

Keywords

stroke; rehabilitation; robotics

Outcome Measures

Primary Outcomes (1)

• Change on the Fugl Meyer motor assessment - subscale lower extremity (FM-LE)

  This scale measures the level of of volitional, selective control of muscles of the paretic lower limb. Scoring: This scale is scored from 0 (no reflex activity) to 34 (volitional movement out of synergies).

  Longitudinal change is determined between the following time points: Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

Secondary Outcomes (7)

• Trunk Control Test - item sitting balance

  Baseline (0-1 week post-stroke)

• Motricity Index - subscale lower extremity (MI-LE)

  Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

• Berg Balance Scale - item standing unsupported

  Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

• Functional Ambulation Categories (FAC)

  Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

• Kinetic analyses of standing balance & gait

  3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

Study Arms (2)

Early Experimental Group

EXPERIMENTAL

N = 20 Intervention = 1-hour sessions of exoskeleton-assisted gait training, using the Ekso GT (Ekso Bionics, CA, USA) in addition to standard care Frequency = 4 times per week for 4 weeks, provided within the first 6 weeks post-stroke

Behavioral: Exoskeleton-assisted gait training

Delayed Experimental Group

EXPERIMENTAL

N = 20 Intervention = 1-hour sessions of exoskeleton-assisted gait training, using the Ekso GT (Ekso Bionics, CA, USA) in addition to standard care Frequency = 4 times per week for 4 weeks, provided between week 8 and week 12 post-stroke

Behavioral: Exoskeleton-assisted gait training

Interventions

Exoskeleton-assisted gait training BEHAVIORAL

In the experimental groups, participants are provided with 1-hour sessions of gait training with robot assistance, 4 times per week for 4 weeks. Assistance is provided by the Ekso GT (Ekso Bionics, Richmond, CA, USA), an exoskeleton consisting of fitted metal braces that supports the legs, feet, and trunk of the patient. Powered motors drive knee and hip joints in the sagittal plane to assist during standing up and walking over level surfaces. Steps are initiated if an active weight-shift towards the stance leg is performed by the patient. The provided assistance in stance and swing is adaptable to the patient's ability and can be adjusted for each leg separately.

Delayed Experimental Group; Early Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic, anterior circulation stroke
• Age: 18 - 90 years
• Baseline assessments within the first 14 days after stroke onset
• Unable to walk independently at baseline (FAC \<3)
• Moderate to severe weakness of the lower limb at baseline (MI \</=75)
• Pre-morbid independence in activities of daily living (mRS \</=2) and gait (FAC \>3)
• Able to communicate and comprehend
• Sufficient motivation to participate
• Provided a written informed consent

You may not qualify if:

• No other neurological condition affecting motor functions of the lower limbs
• Pre-existing musculoskeletal impairment severely affecting the gait pattern
• Body weight \> 100 kg
• Severe spasticity or contractures that prevent safe use of the exoskeleton
• Medically unstable to participate in additional therapy sessions

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Antwerp: collaborator

Study Sites (3)

GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius

Wilrijk, Antwerp, 2610, Belgium

Location

Antwerp University Hospital

Antwerp, Belgium

Location

RevArte Rehabilitation Hospital

Antwerp, Belgium

Location

Related Publications (1)

• Schroder J, Yperzeele L, Embrechts E, Loureiro-Chaves R, Hallemans A, Lafosse C, Truijen S, Kwakkel G, Saeys W. Exoskeleton-assisted training to enhance lower limb motor recovery in subacute stroke: does timing matter? A pilot randomized trial. Front Stroke. 2024 May 14;3:1379083. doi: 10.3389/fstro.2024.1379083. eCollection 2024.

  PMID: 41542275 DERIVED

MeSH Terms

Conditions

Stroke; Paresis; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonas Schröder, PhD Student

  Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

• Wim Saeys, Prof. Dr.

  Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium

  STUDY CHAIR

• Steven Truijen, Prof. Dr.

  Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded assessor will be allocated to a certain participant when she/he was succesfully enrolled. This means that the same assessor will perform the clinical assessments (i.e., FAC, 10-m Walk Test, FM, MI) at the different measurement occasions for this participant to avoid inter-assessor variability effects on longitudinal recovery trajectories.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, PhD researcher

Model Details: Participants will be randomly assigned to either the "early group" or "delayed group". Both groups will be provided a dose- and content-controlled intervention in addition to usual care. The early group will receive this intervention at approximately 2 weeks post-stroke and the delayed group at 8 weeks post-stroke. As such, this study is explicitly designed to investigate the effects of time to initiate rehabilitation on recovery outcomes.

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 1, 2018
• Study Start: November 1, 2018
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)