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

NCT ID: NCT03727919

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2022-02-07

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.

Detailed Description

GENERAL:

Pre-clinical research has pointed towards a time window of enhanced responsiveness to therapy early after stroke. For example, training has led to substantial recovery if initiated 5 or 14, but not 30 days post-stroke in a rodent model (Biernaski 2004). It is suggested that this early period is characterized by heightened levels of plasticity and that training can exploit this leading to improved outcome. The typically observed non-linear recovery pattern in stroke survivors (Kwakkel 2004) might suggest that similar mechanisms are induced in the human brain, however clinical research on this is disappointingly sparse.

In two closely inter-related phases, we aim to examine the biomechanical changes related to walking recovery in general (Phase I) and the specific effects of robot-assisted training (Phase II). By that, we aim to detect a time window in stroke survivors which resembles the same characteristics as observed in animal models. To initiate gait training at an early stage, when patients usually present severe weakness and balance deficits, a mobile exoskeleton is used which is developed to provide intensive walking practice.

OBJECTIVES:

(II.a) Are stroke survivors who train with the assistance of a robot at an early stage more likely to achieve independent walking?

(II.b) Does additional robot-assisted training modulate the recovery of standing and walking ability by enhancing behavioral restitution?

Conditions

Stroke; Paresis; Gait, Hemiplegic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Experimental Group

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

Group Type: EXPERIMENTAL

Exoskeleton-assisted gait training

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Exoskeleton-assisted gait training

Intervention Type: 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.

Interventions

Exoskeleton-assisted gait training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Jonas Schröder

Principle investigator, PhD researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonas Schröder, PhD Student

Role: PRINCIPAL_INVESTIGATOR

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

Wim Saeys, Prof. Dr.

Role: STUDY_CHAIR

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

Steven Truijen, Prof. Dr.

Role: STUDY_DIRECTOR

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

Locations

GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius

Wilrijk, Antwerp, Belgium

Antwerp University Hospital

Antwerp, , Belgium

RevArte Rehabilitation Hospital

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

1S64819N

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

JS-2

Identifier Type: -

Identifier Source: org_study_id