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

Not Applicable

Not yet recruiting

• Conditions: Stroke; Spinal Cord Injury

• Registration Number: NCT06805500
• Lead Sponsor: Roessingh Research and Development

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-27
• Status Verified: 2025-02
• Study First Posted: 2025-02-03
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Study Start: 2025-04
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Walking speed	1 week	The walking speed of the participants during a 6.5 meter walk.

Secondary Outcome Measures

Name	Time	Method
Kinematic data	1 week	Kinematic data, such as the joint angles, will be measured with IMUs
Short Form Berg Balance Scale (SFBBS)	1 week	The balance will be assessed with the Short Form Berg Balance Scale (SFBBS). SFBBS consists of a 7-items scale that measures static and dynamic balance. Each item has a 3-point score (0, 2 and 4 from original Berg Balance Scale). Total score ranges from 0 (poor balance) to 28 (good balance).
Level of Assistance	1 week	The level of assistance will be assessed based on the settings of the device
DON/DOFF	1 week	The time to put the device on (DON) and the device off (DOFF)

Trial Locations

Locations (2)

Roessingh Research and Development; 🇳🇱 Enschede, Netherlands

Sint Maartenskliniek; 🇳🇱 Ubbergen, Netherlands