StrokeNCT06497309
Advanced Technology-Based Rehabilitation for Gait Relearning After Stroke
A study testing Treadmill training, Overground training and DIERS in people with Stroke and Gait Disorders, Neurologic, run by National Institute for Medical Rehabilitation, Hungary at 1 site in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Stroke, Gait Disorders, Neurologic
- What is being tested?
- Treadmill training, Overground training and DIERS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2024to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
National Institute for Medical Rehabilitation
Budapest, Pest County, 1121
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Gait Disorders, Neurologic
- Being tested
- Treadmill training, Overground training, DIERS, Traditional physiotherapy assessments
- Keywords
- Rehabilitation, Physical Therapy, High-tech devices, Stroke, Gait re-learning
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill trainingDevice
Therapy with treadmill-based advanced technology device.
Overground trainingDevice
Therapy using an advanced technological device enables exercise on the ground.
DIERSDevice
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.
Traditional physiotherapy assessmentsOther
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 group | Role | What they receive |
|---|---|---|
| Treadmill group | Experimental | 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. Receives: Device: Treadmill training; Device: DIERS; Other: Traditional physiotherapy assessments |
| Overground group | Experimental | 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. Receives: Device: Overground training; Device: DIERS; Other: Traditional physiotherapy assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balancing skills
Berg Balance Test (values between 0-56, higher score means better outcome).
Measured: Baseline and immediately after the 4-week intervention
Balancing skills
Timed Up and Go Test (how many seconds it takes the patient to complete the task).
Measured: Baseline and immediately after the 4-week intervention
Balancing skills
Weight distribution (%) using the DIERS medical device.
Measured: Baseline and immediately after the 4-week intervention
Balancing skills
COP movement (mm) using the DIERS medical device.
Measured: Baseline and immediately after the 4-week intervention
Balancing skills
Sway area (mm2) using the DIERS medical device.
Measured: Baseline and immediately after the 4-week intervention
Balancing skills
Romberg opened eyes, closed eyes (mm) using the DIERS medical device.
Measured: Baseline and immediately after the 4-week intervention
Balancing skills
Strength of the lower limbs (hip extension, flexion, adduction and abduction) and the trunk (flexion, extension, rotation, lateroflexion) (N) using the DIERS medical device.
Measured: Baseline and immediately after the 4-week intervention
Gait parameters
6-minute gait test (m).
Measured: Baseline and immediately after the 4-week intervention
Gait parameters
10-meter gait test (min).
Measured: Baseline and immediately after the 4-week intervention
Gait parameters
step length (mm), using the DIERS medical device.
Measured: Baseline and immediately after the 4-week intervention
Gait parameters
Step width (mm), using the DIERS medical device.
Measured: Baseline and immediately after the 4-week intervention
Gait parameters
Heel strike (N), using the DIERS medical device.
Measured: Baseline and immediately after the 4-week intervention
Gait parameters
COP movement (mm), using the DIERS medical device.
Measured: Baseline and immediately after the 4-week intervention
Functional independence
Based on FIM (maximum 126 points, higher score means better outcome).
Measured: Baseline and immediately after the 4-week intervention
Functional independence
Based on Barthel (values between 0-99, higher score means better outcome).
Measured: Baseline and immediately after the 4-week intervention
Change in Fugl-Meyer Assessment - Lower Extremity (FMA-LE) Score
The Fugl-Meyer Assessment-Lower Extremity (FMA-LE) evaluates lower-extremity motor impairment after stroke. The total motor score ranges from 0 to 34 points, with higher scores indicating better lower-extremity motor function.
Measured: Baseline and immediately after the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Jan 2024
- Primary completion11 Feb 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Rehabilitation, Hungary
- Sponsor type
- Other government
- Collaborators
- Semmelweis University
- Responsible party
- Sponsor
- Investigators
- Gábor Fazekas, MD, PhD, Principal investigator, National Institute for Medical Rehabilitation, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497309
- Sponsor's protocol ID
- OMINT-58-1/2023
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Technology-based Rehabilitation Programmes to Support Gait Re-learning After Stroke
- ClinicalTrials.gov ID
- NCT06497309
- Acronym / sponsor ID
- OMINT-58-1/2023
- Conditions
- Stroke, Gait Disorders, Neurologic
- Keywords
- Rehabilitation, Physical Therapy, High-tech devices, Stroke, Gait re-learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Institute for Medical Rehabilitation, HungaryOther government
- Collaborators
- Semmelweis University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill group | Experimental | Device: Treadmill training, Device: DIERS, Other: Traditional physiotherapy assessmentsIn 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. |
| Overground group | Experimental | Device: Overground training, Device: DIERS, Other: Traditional physiotherapy assessmentsIn 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill trainingTherapy with treadmill-based advanced technology device. | Device | Treadmill group |
| Overground trainingTherapy using an advanced technological device enables exercise on the ground. | Device | Overground group |
| DIERSThe 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. | Device | Overground group, Treadmill group |
| Traditional physiotherapy assessmentsTraditional 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. | Other | Overground group, Treadmill group |
Primary outcome
Balancing skills
Time frame: Baseline and immediately after the 4-week intervention
Berg Balance Test (values between 0-56, higher score means better outcome).
Balancing skills
Time frame: Baseline and immediately after the 4-week intervention
Timed Up and Go Test (how many seconds it takes the patient to complete the task).
Balancing skills
Time frame: Baseline and immediately after the 4-week intervention
Weight distribution (%) using the DIERS medical device.
Balancing skills
Time frame: Baseline and immediately after the 4-week intervention
COP movement (mm) using the DIERS medical device.
Balancing skills
Time frame: Baseline and immediately after the 4-week intervention
Sway area (mm2) using the DIERS medical device.
Balancing skills
Time frame: Baseline and immediately after the 4-week intervention
Romberg opened eyes, closed eyes (mm) using the DIERS medical device.
Balancing skills
Time frame: Baseline and immediately after the 4-week intervention
Strength of the lower limbs (hip extension, flexion, adduction and abduction) and the trunk (flexion, extension, rotation, lateroflexion) (N) using the DIERS medical device.
Gait parameters
Time frame: Baseline and immediately after the 4-week intervention
6-minute gait test (m).
Gait parameters
Time frame: Baseline and immediately after the 4-week intervention
10-meter gait test (min).
Gait parameters
Time frame: Baseline and immediately after the 4-week intervention
step length (mm), using the DIERS medical device.
Gait parameters
Time frame: Baseline and immediately after the 4-week intervention
Step width (mm), using the DIERS medical device.
Gait parameters
Time frame: Baseline and immediately after the 4-week intervention
Heel strike (N), using the DIERS medical device.
Gait parameters
Time frame: Baseline and immediately after the 4-week intervention
COP movement (mm), using the DIERS medical device.
Functional independence
Time frame: Baseline and immediately after the 4-week intervention
Based on FIM (maximum 126 points, higher score means better outcome).
Functional independence
Time frame: Baseline and immediately after the 4-week intervention
Based on Barthel (values between 0-99, higher score means better outcome).
Change in Fugl-Meyer Assessment - Lower Extremity (FMA-LE) Score
Time frame: Baseline and immediately after the 4-week intervention
The Fugl-Meyer Assessment-Lower Extremity (FMA-LE) evaluates lower-extremity motor impairment after stroke. The total motor score ranges from 0 to 34 points, with higher scores indicating better lower-extremity motor function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gábor Fazekas, MD, PhD principal investigator
National Institute for Medical Rehabilitation, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill training, Overground training and DIERS in people with Stroke and Gait Disorders, Neurologic, run by National Institute for Medical Rehabilitation, Hungary at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balancing skills (time frame: Baseline and immediately after the 4-week intervention). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.