Robotic Assisted Balance and Exoskeleton Training (REACTION) in Neurorehabilitation: a Feasibility Study

N/ANot Yet RecruitingNCT06805500

Roessingh Research and Development20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Stroke Spinal Cord Injury

Interventions

REACTIONDEVICE

Combination of a exoskeleton and gait trainer

ABLE RegainDEVICE

Exoskeleton

GABLE CoreDEVICE

Gait trainer

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (2)

Roessingh Research and Development

Enschede, Netherlands

Sint Maartenskliniek

Ubbergen, Netherlands

Outcomes

Primary Outcomes

Walking speed

The walking speed of the participants during a 6.5 meter walk.

Time frame: 1 week

Secondary Outcomes

Kinematic data

Kinematic data, such as the joint angles, will be measured with IMUs

Time frame: 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).

Time frame: 1 week

DON/DOFF

The time to put the device on (DON) and the device off (DOFF)

Time frame: 1 week

Level of Assistance

The level of assistance will be assessed based on the settings of the device

Time frame: 1 week

Central Contacts

Celine Bouwmeester, MSc

CONTACT

+31 (0)88 0875 711 c.bouwmeester@rrd.nl

Data from ClinicalTrials.gov

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