StrokeREACTIONNCT06805500
Robotic Assisted Balance and Exoskeleton Training (REACTION) in Neurorehabilitation: a Feasibility Study
A study testing REACTION, ABLE Regain and GABLE Core in people with Stroke and Spinal Cord Injury, run by Roessingh Research and Development at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Stroke, Spinal Cord Injury
- What is being tested?
- REACTION, ABLE Regain and GABLE Core
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesNetherlands
- Study dates
- 7 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Roessingh Research and Development
Enschede
Sint Maartenskliniek
Ubbergen
About this study
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
Read the 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.
- Conditions
- Stroke, Spinal Cord Injury
- Being tested
- REACTION, ABLE Regain, GABLE Core
- Keywords
- exoskeleton, gait trainer, neurological disease, rehabilitation
- Medical subject headings
- Stroke, Spinal Cord Injuries, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REACTIONDevice
Combination of a exoskeleton and gait trainer
ABLE RegainDevice
Exoskeleton
GABLE CoreDevice
Gait trainer
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Not described Receives: Device: REACTION; Device: ABLE Regain; Device: GABLE Core |
What is being measured
The primary outcome is the main question the study is designed to answer.
DON/DOFF
The time to put the device on (DON) and the device off (DOFF)
Measured: 1 week
Secondary outcomes (4)
Walking speed
The walking speed of the participants during a 6.5 meter walk.
Measured: 1 week
Kinematic data
Kinematic data, such as the joint angles, will be measured with IMUs
Measured: 1 week
Short Form Berg Balance Scale (SFBBS)
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).
Measured: 1 week
Level of Assistance
The level of assistance will be assessed based on the settings of the device
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start7 May 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicentred feasibility study
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roessingh Research and Development
- Sponsor type
- University, hospital or other
- Collaborators
- Sint Maartenskliniek
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805500
- Sponsor's protocol ID
- NL 2025-17884
- Other IDs
- 1789
- Acronym
- REACTION
- Status last verified
- May 2026
- First submitted
- 16 Jan 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Assisted Balance and Exoskeleton Training (REACTION) in Neurorehabilitation: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06805500
- Acronym / sponsor ID
- REACTION / NL 2025-17884
- Conditions
- Stroke, Spinal Cord Injury
- Keywords
- exoskeleton, gait trainer, neurological disease, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Roessingh Research and DevelopmentUniversity, hospital or other
- Collaborators
- Sint Maartenskliniek
- Study start
- 7 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicentred feasibility study
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: REACTION, Device: ABLE Regain, Device: GABLE Core |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REACTIONCombination of a exoskeleton and gait trainer | Device | Experimental arm |
| ABLE RegainExoskeleton | Device | Experimental arm |
| GABLE CoreGait trainer | Device | Experimental arm |
Primary outcome
DON/DOFF
Time frame: 1 week
The time to put the device on (DON) and the device off (DOFF)
4 secondary outcomes
Walking speed
Time frame: 1 week
Kinematic data
Time frame: 1 week
Short Form Berg Balance Scale (SFBBS)
Time frame: 1 week
Level of Assistance
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided. Upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REACTION, ABLE Regain and GABLE Core in people with Stroke and Spinal Cord Injury, run by Roessingh Research and Development at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DON/DOFF (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.