Robotic Assisted Balance and Exoskeleton Training (REACTION) in Neurorehabilitation: a Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-01-31

Brief Summary

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The goal of this clinical trial is to explore the effect on walking speed of a new robotic assisted balance and gait trainer (REACTION) and their subsystems in individuals with neurological disorders. The study will provide insight in the feasibility of REACTION.

Participants will:

* Participate in two sessions in which every session contains a walking task and balance tasks
* end the study with a semi-structured interview

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Detailed Description

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The first day will be focusing on 4 conditions: tasks without aid, tasks with regular aid, task with the ABLE Regain and tasks with REACTION. The first and third condition consist of a walking task and balance tasks, The second and fourth condition is only focusing on the walking task with the aim of getting familiar to the device and the walking task.

The second day will also be focusing on four conditions: tasks without aid, tasks with aid, tasks with the GABLE Core and task with REACTION (Fig 3.2). The conditions 'tasks without aid', 'tasks with the GABLE Core' and 'tasks with REACTION' consist of a walking task and balance tasks (similar to day 1). The condition 'tasks with aid' only consists of a walking task.

A semi-structured interview with the corresponding physiotherapist and patient will be held to gather more information about usability and feasibility of REACTION from a therapist's and patient's perspective.

Conditions

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Stroke Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Multicentred feasibility study

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Experimental arm

Group Type EXPERIMENTAL

REACTION

Intervention Type DEVICE

Combination of a exoskeleton and gait trainer

ABLE Regain

Intervention Type DEVICE

Exoskeleton

GABLE Core

Intervention Type DEVICE

Gait trainer

Interventions

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REACTION

Combination of a exoskeleton and gait trainer

Intervention Type DEVICE

ABLE Regain

Exoskeleton

Intervention Type DEVICE

GABLE Core

Gait trainer

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 16 years
* Able to give informed consent

Stroke patients:

* first-ever ischemic or haemorrhagic stroke
* FAC score between 3 and 4
* (Sub)acute or chronic phase

SCI patients:

* Neurological injury levels ranging from C5 to T9
* Motor incomplete spinal cord injury (ASIA impairment score of C or D)
* Able to walk independently (without physical support)

Exclusion Criteria

A potential participant who meets any of the following criteria will be excluded from participation in this study:

* Premorbid disability of lower extremity
* Progressive neurological diseases like dementia or Parkinson
* Skin lesions or severely impaired sensation at the hemiparetic leg
* Contraindication for mobilization, like lower limb fracture
* Insufficient knowledge of the Dutch language to understand the purpose or meth-ods of the study
* Pregnancy

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No