REACTION
DeviceCombination of a exoskeleton and gait trainer
NCT Number: NCT06805500
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
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Notify Me16 year and older
All sexes
Interventional
Not applicable
Roessingh Research and Development, Enschede, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
Combination of a exoskeleton and gait trainer
Exoskeleton
Gait trainer
Time frame: 1 week
The time to put the device on (DON) and the device off (DOFF)
Time frame: 1 week
The walking speed of the participants during a 6.5 meter walk.
Time frame: 1 week
Kinematic data, such as the joint angles, will be measured with IMUs
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).
Time frame: 1 week
The level of assistance will be assessed based on the settings of the device
Roessingh Research and Development
Other
Acronym: REACTION
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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