Robotic Assisted Balance and Exoskeleton Training (REACTION) in Neurorehabilitation: a Feasibility Study (REACTION)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Enschede, Netherlands
- Roessingh Research and Development
-
Ubbergen, Netherlands
- Sint Maartenskliniek
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental arm
|
Combination of a exoskeleton and gait trainer
Exoskeleton
Gait trainer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DON/DOFF
Time Frame: 1 week
|
The time to put the device on (DON) and the device off (DOFF)
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking speed
Time Frame: 1 week
|
The walking speed of the participants during a 6.5 meter walk.
|
1 week
|
|
Kinematic data
Time Frame: 1 week
|
Kinematic data, such as the joint angles, will be measured with IMUs
|
1 week
|
|
Level of Assistance
Time Frame: 1 week
|
The level of assistance will be assessed based on the settings of the device
|
1 week
|
|
Short Form Berg Balance Scale (SFBBS)
Time Frame: 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).
|
1 week
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL 2025-17884
- 1789 (Other Grant/Funding Number: EUREKA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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