Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1789 | Other Grant/Funding Number | EUREKA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sint Maartenskliniek | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REACTION | Device | Combination of a exoskeleton and gait trainer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| DON/DOFF | The time to put the device on (DON) and the device off (DOFF) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Walking speed | The walking speed of the participants during a 6.5 meter walk. | 1 week |
| Kinematic data | Kinematic data, such as the joint angles, will be measured with IMUs |
Not provided
In order to be eligible to participate in this study, a participant must meet all of the following criteria:
Stroke patients:
SCI patients:
Exclusion Criteria:
A potential participant who meets any of the following criteria will be excluded from participation in this study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roessingh Research and Development | Enschede | Netherlands | ||||
| Sint Maartenskliniek |
Upon reasonable request
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D013119 | Spinal Cord Injuries |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Multicentred feasibility study
Not provided
Not provided
Not provided
Not provided
| ABLE Regain |
| Device |
Exoskeleton |
|
| GABLE Core | Device | Gait trainer |
|
| 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). | 1 week |
| Level of Assistance | The level of assistance will be assessed based on the settings of the device | 1 week |
| Ubbergen |
| Netherlands |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |