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

Roessingh Research and Development

Status

Not yet enrolling

Conditions

Stroke

Spinal Cord Injury

Treatments

Device: REACTION

Device: GABLE Core

Device: ABLE Regain

Study type

Interventional

Funder types

Other

Identifiers

NCT06805500

NL 2025-17884

1789

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

In order to be eligible to participate in this study, a participant must meet all of the following 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