NCT06805500

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 7, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

January 16, 2025

Last Update Submit

May 1, 2026

Conditions

StrokeSpinal Cord Injury

Keywords

exoskeletongait trainerneurological diseaserehabilitation

Outcome Measures

Primary Outcomes (1)

  • DON/DOFF

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

    1 week

Secondary Outcomes (4)

  • Walking speed

    1 week

  • Kinematic data

    1 week

  • Short Form Berg Balance Scale (SFBBS)

    1 week

  • Level of Assistance

    1 week

Study Arms (1)

Experimental arm

EXPERIMENTAL
Device: REACTIONDevice: ABLE RegainDevice: GABLE Core

Interventions

REACTIONDEVICE

Combination of a exoskeleton and gait trainer

Experimental arm
ABLE RegainDEVICE

Exoskeleton

Experimental arm
GABLE CoreDEVICE

Gait trainer

Experimental arm

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Roessingh Research and Development

Enschede, Netherlands

Location

Sint Maartenskliniek

Ubbergen, Netherlands

Location

MeSH Terms

Conditions

StrokeSpinal Cord InjuriesNervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Multicentred feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2025

First Posted

February 3, 2025

Study Start

May 7, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 7, 2026

Record last verified: 2026-05

Locations

NL(2)