Robotic Assisted Balance and Exoskeleton Training (REACTION) in Neurorehabilitation: a Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- DON/DOFF
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Experimental arm
Intervention: REACTION (Device)
Experimental arm
Intervention: ABLE Regain (Device)
Experimental arm
Intervention: GABLE Core (Device)
Outcomes
Primary Outcomes
DON/DOFF
Time Frame: 1 week
The time to put the device on (DON) and the device off (DOFF)
Secondary Outcomes
- Kinematic data(1 week)
- Short Form Berg Balance Scale (SFBBS)(1 week)
- Level of Assistance(1 week)
- Walking speed(1 week)