Clinical trial NCT06805500: Robotic Assisted Balance and Exoskeleton Training (REACTION) in Neurorehabilitation: a Feasibility Study
Official title: Robotic Assisted Balance and Exoskeleton Training (REACTION) in Neurorehabilitation: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Spinal Cord Injury
Keywords: exoskeleton
gait trainer
neurological disease
rehabilitation
Lead sponsor: Roessingh Research and Development
Sponsor class: OTHER
Collaborators: name: Sint Maartenskliniek
First posted: 2025-02-03
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicentred feasibility study
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility 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

Primary outcomes:
measure: Walking speed
timeFrame: 1 week
Secondary outcomes:
measure: Kinematic data
timeFrame: 1 week
measure: Short Form Berg Balance Scale (SFBBS)
timeFrame: 1 week
measure: DON/DOFF
timeFrame: 1 week
measure: Level of Assistance
timeFrame: 1 week
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Roessingh Research and Development
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek
Study officials:
References: