Advanced Technology-based Rehabilitation Post-stroke Gait Re-learning

May 12, 2026 updated by: National Institute for Medical Rehabilitation, Hungary

Advanced Technology-based Rehabilitation Programmes to Support Gait Re-learning After Stroke

High-tech therapy, an innovative field of neurorehabilitation, has expanded rapidly in recent years. Advances in technology have enabled the use of devices that can assist with movement development from simple movements to more complex tasks.

This research investigates the effectiveness of rehabilitation programmes that complement robot-assisted therapy to help people relearn to walk in post-stroke rehabilitation. This would be measured in two variations, with the patient (in addition to a complex rehabilitation programme of conventional physiotherapy, occupational therapy, hydrotherapy, etc.) receiving either treadmill or no treadmill treatment. In both cases, the therapies will be carried out with advanced technology-based equipment (both treatments are part of the daily routine of the Institute's treatments, and the equipment will be used according to the instructions in the user manual), the C-Mill interactive robot-assisted device will be used for treadmill therapy, and the Andago robot-assisted device for non- treadmill therapy. There is no sharp distinction between the two systems. The inclusion and exclusion criteria are set so patients' conditions meet the indications for both devices, and patients eligible for treatment with one device are included in the other.

In our study, 80 patients will be selected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of this research is to investigate the effectiveness of rehabilitation programmes in post-stroke rehabilitation using advanced technology-based therapy to assist in relearning walking. This will be measured in two variations: the patient will be randomly assigned (in addition to a complex rehabilitation programme of traditional physiotherapy, occupational therapy, hydrotherapy, etc.) to receive either treadmill treatment or no treadmill treatment. In both cases, the therapies are carried out using advanced technological equipment.

The investigators will enrol 80 people in our study. The comparison will be between 40 and 40 people, the main groups differing in terms of the type of advanced technology device used in the rehabilitation programme and whether they received treadmill or non-treadmill treatment. In total, they will participate in 20 sessions of therapy.

Furthermore, the investigators observe whether a greater change in condition can be measured in the early post-stroke period (0-3 months) or the late period (3 months-1 year) in specific parameters of the patient's gait. The time since the stroke provides an opportunity for subgroup analysis, but the number of cases limits this. This is significant because it is still an open question in the international literature regarding advanced technology-based therapy.

In all cases, the examination starts and ends with the DIERS motion analysis system, a light-optical scanning method based on VRS (Video Raster Stereography) and a sensor-equipped treadmill that allows the measurement of several parameters of gait and balancing ability. In addition, traditional physiotherapy assessment methods (Timed Up and Go, Berg Balance Test, 6-minute gait test, 10-metre gait test, Functional Independence Measure, Barthel) are used to assess gait pattern and self-sufficiency.

Study Type

Observational

Enrollment (Actual)

80

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
    • Pest County
      • Budapest, Pest County, Hungary, 1121
        • National Institute for Medical Rehabilitation

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

Sampling Method

Probability Sample

Study Population

Patients of the National Institute for Medical Rehabilitation, Budapest, Hungary

Description

Inclusion Criteria:

  • Hemiparetic patient who has had a stroke;
  • ischaemic or haemorrhagic stroke confirmed by CT or MRI;
  • female or male between 40 and 75 years of age;
  • subgroup 1: less than 3 months since stroke,
  • subgroup 2: more than 3 months but less than 1 year since stroke;
  • physical fitness adequate for the exertion of the treatment;
  • right or left lower limb involvement;
  • score 3 on the Functional Ambulation Categories (FAC) scale, i.e. Indicates a patient who can ambulate on a level surface without manual contact of another person but requires standby guarding of one person either for safety or verbal cueing;
  • or score 4 on the Functional Ambulation Categories (FAC) scale, i.e. Indicates a patient who can ambulate independently on a level surface but requires supervision to negotiate (e.g. stairs, inclines, non-flat surfaces);
  • be able to participate in therapy and cooperate based on cognitive function;
  • signed informed consent.

Exclusion Criteria:

  • More than 1 year has passed since the stroke;
  • scores less than or equal to 3 on the Functional Ambulation Categories (FAC) scale;
  • patients who were unable to walk independently before the stroke;
  • patients treated with botulinum toxin in the lower limb in the last 3 months;
  • use of other lower limb advanced technology treatments during the study;
  • a person with limited capacity;
  • not physically able to bear weight;
  • severe aphasia (impairment of understanding or expression that severely impedes communication);

  • other condition that precludes the use of C-Mill or Andago:

    • severe emotional disturbance;
    • mentally incapacitated patient;
    • severe contracture or spasticity preventing the patient from being placed in the machine;
    • pregnancy;
    • skin disease in the area of contact with the straps;
    • fever;
    • unhealed fracture fracture;
    • inability to use the device due to weight and height limitations of the device;
    • epilepsy if you have had a seizure within a year;
    • severe visual impairment.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treadmill group
In both groups, using advanced technology-based tools (both treatments are part of the daily routine of the Institute's treatments and are used according to the instructions in the user manual), for the treadmill therapy, we use the C-Mill interactive high-tech device.
Device: Treadmill training
Therapy with treadmill-based advanced technology device.
Device: DIERS
The examination starts and ends with the DIERS motion analysis system, a light-optical scanning method based on VRS (Video Raster Stereography) and a sensor-equipped treadmill that allows the measurement of several parameters of gait and balancing ability.
Other: Traditional physiotherapy assessments
Traditional physiotherapy assessment methods (Timed Up and Go, Berg Balance Test, 6-minute gait test, 10-metre gait test, Functional Independence Measure, Barthel) are used to assess gait pattern and self-sufficiency.
Overground group
In both groups, we use an advanced technology-based device (both treatments are part of the daily routine of the Institute's treatments and are used according to the instructions in the user manual), and the Andago high-tech device for non-runner therapy.
Device: DIERS
The examination starts and ends with the DIERS motion analysis system, a light-optical scanning method based on VRS (Video Raster Stereography) and a sensor-equipped treadmill that allows the measurement of several parameters of gait and balancing ability.
Other: Traditional physiotherapy assessments
Traditional physiotherapy assessment methods (Timed Up and Go, Berg Balance Test, 6-minute gait test, 10-metre gait test, Functional Independence Measure, Barthel) are used to assess gait pattern and self-sufficiency.
Device: Overground training
Therapy using an advanced technological device enables exercise on the ground.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balancing skills
Time Frame: Through study completion, an average of 2 years.
Berg Balance Test (values between 0-56, higher score means better outcome).
Through study completion, an average of 2 years.
Balancing skills
Time Frame: Through study completion, an average of 2 years.
Timed Up and Go Test (how many seconds it takes the patient to complete the task).
Through study completion, an average of 2 years.
Balancing skills
Time Frame: Through study completion, an average of 2 years.
Weight distribution (%) using the DIERS medical device.
Through study completion, an average of 2 years.
Balancing skills
Time Frame: Through study completion, an average of 2 years.
COP movement (mm) using the DIERS medical device.
Through study completion, an average of 2 years.
Balancing skills
Time Frame: Through study completion, an average of 2 years.
Sway area (mm2) using the DIERS medical device.
Through study completion, an average of 2 years.
Balancing skills
Time Frame: Through study completion, an average of 2 years.
Romberg opened eyes, closed eyes (mm) using the DIERS medical device.
Through study completion, an average of 2 years.
Balancing skills
Time Frame: Through study completion, an average of 2 years.
Strength of the lower limbs (hip extension, flexion, adduction and abduction) and the trunk (flexion, extension, rotation, lateroflexion) (N) using the DIERS medical device.
Through study completion, an average of 2 years.
Gait parameters
Time Frame: Through study completion, an average of 2 years.
6-minute gait test (m).
Through study completion, an average of 2 years.
Gait parameters
Time Frame: Through study completion, an average of 2 years.
10-meter gait test (min).
Through study completion, an average of 2 years.
Gait parameters
Time Frame: Through study completion, an average of 2 years.
step length (mm), using the DIERS medical device.
Through study completion, an average of 2 years.
Gait parameters
Time Frame: Through study completion, an average of 2 years.
Step width (mm), using the DIERS medical device.
Through study completion, an average of 2 years.
Gait parameters
Time Frame: Through study completion, an average of 2 years.
Heel strike (N), using the DIERS medical device.
Through study completion, an average of 2 years.
Gait parameters
Time Frame: Through study completion, an average of 2 years.
COP movement (mm), using the DIERS medical device.
Through study completion, an average of 2 years.
Functional independence
Time Frame: Through study completion, an average of 2 years.
Based on FIM (maximum 126 points, higher score means better outcome).
Through study completion, an average of 2 years.
Functional independence
Time Frame: Through study completion, an average of 2 years.
Based on Barthel (values between 0-99, higher score means better outcome).
Through study completion, an average of 2 years.

Collaborators and Investigators

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

Sponsor

National Institute for Medical Rehabilitation, Hungary

Collaborators

Semmelweis University

Investigators

  • Principal Investigator: Gábor Fazekas, MD, PhD, National Institute for Medical Rehabilitation, Hungary

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)

January 1, 2024

Primary Completion (Actual)

February 11, 2026

Study Completion (Actual)

February 12, 2026

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMINT-58-1/2023

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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