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Completed

NCT Number: NCT06805500

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

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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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roessingh Research and Development, Enschede, Netherlands

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About this study

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.

Who can participate

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:

  • 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

Treatment and study plan

REACTION

Device

Combination of a exoskeleton and gait trainer

ABLE Regain

Device

Exoskeleton

GABLE Core

Device

Gait trainer

Primary outcomes

  1. DON/DOFF

    Time frame: 1 week

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

Secondary outcomes

  1. Walking speed

    Time frame: 1 week

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

  2. Kinematic data

    Time frame: 1 week

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

  3. Short Form Berg Balance Scale (SFBBS)

    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).

  4. Level of Assistance

    Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

Roessingh Research and Development

Other

Collaborators

  • Sint Maartenskliniek

Registry information

Acronym: REACTION

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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