Exoskeleton-assisted Neurorehabilitation

January 10, 2026 updated by: Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital

Exoskeleton-assisted Neurorehabilitation: Current Perspectives and Future Directions - A Pilot Study

  • Objective assesment of the feasibility of integrating the Ekso Bionics - Ekso NR device into outpatient care
  • Objective assesment of quality of life, functionality and clinical symptomps of patients with stroke, cerebellar ataxia, spinal cord injury, and spastic paraparesis
  • Comparison of measured data and follow-up of changes in relation to themselves and each other
  • Analyzing the effects of the exoskeleton among the patients
  • Assessing the safety, possible side effects and tolerability of the EksoNR

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy County Kaposi Mor Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • confirmed diagnosis of spinal cord injury (at or below the C4 level)
  • having cerebellar ataxia diagnosis
  • confirmed spastic paraparesis
  • ischemic stroke

Exclusion Criteria:

  • height below 150 cm or above 190 cm
  • body weight exceeded 100 kg
  • multiple strokes in medical history
  • systolic blood pressure less than 120 or higher than 160 mmHg
  • orthostatic hypotension
  • arotid artery stenosis
  • severe heart disease
  • hemophilia
  • traumatic brain injury
  • seizure disorder
  • untreated diabetes
  • abnormal electroencephalography
  • abnormal blood panel
  • use of sedatives
  • irregular medication use
  • severe aphasia (Western Aphasia Battery ≤ 25)
  • severe visual or hearing impairment
  • severe sensory dysfunction
  • severe orthopedic problems
  • alcoholism
  • drug use
  • smoking after diagnosis of stroke
  • unable to walk at least 10 m with or without assistance in 6 minutes
  • BBS score ≤ 32
  • BI score ≤ 70
  • current participation in individual or group exercise program outside of standard physical therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ekso Group
Improving gait with the help of the Eksobionics EksoNR device
Device: Gait training with exoskeleton
EksoNR is a wearable, battery-powered bionic exoskeleton that enables individuals with neurological or muscular injuries, lower limb weakness, paralysis, or gait disorders to stand and walk on flat surfaces. The hip and knee joints are powered by motors, and all movements are performed either by the patient's specific movements or by using an external controller. The robot's functions can be adjusted to determine the level of assistance the device provides to the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Independence Measure (FIM)
Time Frame: 4 weeks
Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is.
4 weeks
Barthel Index (BI)
Time Frame: 4 weeks
Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS)
Time Frame: 4 weeks
Measures balance, scaling 0-56 points, with lower scores suggesting good balance/indipandance.
4 weeks
Tinetti
Time Frame: 4 weeks
Balance and walking, scaling 0-28 points, with lower scores indicating higher fall risk.
4 weeks
Timed Up and Go (TUG)
Time Frame: 4 weeks
Measures functional mobility and fall risk, scaling 0-180 seconds. The less time, the lower the risk of falling.
4 weeks
Walking Index for Spinal Cord Injury II. (WISCI II.)
Time Frame: 4 weeks
21 - level ordinal scale scoring walking ability after SCI, from total depenence (0) to independent walking (20).
4 weeks
6 minute walk test (6MWT)
Time Frame: 4 weeks
Functional exercise capacity, scaling 0-800 meters. The more meters a patient achieves, the better their cardiopulmonary function.
4 weeks
EG-5D-5L
Time Frame: 4 weeks
Health-related quality of life, having 5 dimensions and 5 levels, plus a Visual Analogue Scale (EQ-VAS)
4 weeks
WHO Quality of Life (WHOQOL)
Time Frame: 4 weeks
Measuring quality of life, scoring involves rating items on a 1-5 Likert scale, then tranforming these raw scores into a 0-100 scale for four main domains (Physical Health, Psychological, Social Relationships, Environment). The higher the score, the better the quality of life is.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Somogy Megyei Kaposi Mór Teaching Hospital

Investigators

  • Principal Investigator: József Dr. habil. Tollár, Somogy County Kaposi Mor Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

January 10, 2026

First Submitted That Met QC Criteria

January 10, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKEB2023/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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