Robot-Assisted Training Versus Standard Training in Ischemic Stroke

Summary

The aim of this randomised controlled trial (RCT) nested in a prospective cohort, is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation.

The main hypothesis of the study is:

Robot-assisted training has a superior effect on motor function (Fugl-Meyer Lower Extremity Assessment; primary outcome), physical function, fatigue, and quality of life in moderately-to-severely impaired chronic stroke-affected individuals in comparison to standard training.

Conditions

• Stroke
• Ischemic Stroke

Interventions

OTHER

Robot-assisted Training

Gait training and functional strength training facilitated by body weight unloading robotic technology yielding a dynamic unloading force applied to the body centre of mass. Gait training will be conducted both on treadmill and overground. Functional strength training exercises include sit-to-stand, stair-walking, step-ups etc. The goal is to gradually reduce body weight unloading as participants progress through the intervention period.

OTHER

Standard Training

Gait training and functional strength training facilitated without the use of body weight unloading robotic technology, thereby only allowing manual assistance from physiotherapists. The goal of training is the same as in the intervention group, however no body weight unloading device will be implemented in the active control group.

Sponsors & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Herlev and Gentofte Hospital

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Sygehus Lillebaelt

  collaborator OTHER

• Danish Association of the Physically Disabled

  collaborator UNKNOWN

• Odense University Hospital

  lead OTHER

Principal Investigators

• Jon Skovgaard Jensen, Ph.d.-student · Department of Clinical Research, University of Southern Denmark

• Anders Holsgaard-Larsen, Professor · Odense University Hospital and Department of Clinical Research, University of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2026-03-01

Completion

2027-02-01

Countries

• Denmark

Study Locations