Stroke, Spinal Cord Injury
Conditions
Keywords
exoskeleton, gait trainer, neurological disease, rehabilitation
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.
Interventions
DEVICEREACTION
Combination of a exoskeleton and gait trainer
DEVICEABLE Regain
Exoskeleton
DEVICEGABLE Core
Gait trainer
Sponsors
Sint Maartenskliniek
Roessingh Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Multicentred feasibility study
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking speed | 1 week | The walking speed of the participants during a 6.5 meter walk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kinematic data | 1 week | Kinematic data, such as the joint angles, will be measured with IMUs |
| Short Form Berg Balance Scale (SFBBS) | 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). |
| DON/DOFF | 1 week | The time to put the device on (DON) and the device off (DOFF) |
| Level of Assistance | 1 week | The level of assistance will be assessed based on the settings of the device |
Countries
Netherlands
Contacts
Primary ContactCeline Bouwmeester, MSc
Outcome results
None listed