StrokeNCT07352085
Exoskeleton-assisted Neurorehabilitation
A study testing Gait training with exoskeleton in people with Stroke and Spinal Cord Injuries (Complete and Incomplete), run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Spinal Cord Injuries (Complete and Incomplete), Cerebellar Ataxia
- What is being tested?
- Gait training with exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jun 2024to 28 Feb 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed diagnosis of spinal cord injury (at or below the C4 level)
- having cerebellar ataxia diagnosis
- confirmed spastic paraparesis
- ischemic stroke
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Somogy County Kaposi Mór Teaching Hospital
Kaposvár, Somogy County, 7400
About this study
Official title: 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
- Conditions
- Stroke, Spinal Cord Injuries (Complete and Incomplete), Cerebellar Ataxia, Spastic Paraplegia
- Being tested
- Gait training with exoskeleton
- Keywords
- Spinal cord injury, Ataxia, Stroke, Spastic paraplegia, Altered gait pattern, Eksobionics, Robotic therapy
- Medical subject headings
- Stroke, Spinal Cord Injuries, Cerebellar Ataxia, Paraplegia, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait training with exoskeletonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Ekso Group | Active comparator | Improving gait with the help of the Eksobionics EksoNR device Receives: Device: Gait training with exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM)
Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is.
Measured: 4 weeks
Barthel Index (BI)
Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency.
Measured: 4 weeks
Secondary outcomes (7)
Timed Up and Go (TUG)
Measures functional mobility and fall risk, scaling 0-180 seconds. The less time, the lower the risk of falling.
Measured: 4 weeks
Berg Balance Scale (BBS)
Measures balance, scaling 0-56 points, with lower scores suggesting good balance/indipandance.
Measured: 4 weeks
Tinetti
Balance and walking, scaling 0-28 points, with lower scores indicating higher fall risk.
Measured: 4 weeks
Walking Index for Spinal Cord Injury II. (WISCI II.)
21 - level ordinal scale scoring walking ability after SCI, from total depenence (0) to independent walking (20).
Measured: 4 weeks
6 minute walk test (6MWT)
Functional exercise capacity, scaling 0-800 meters. The more meters a patient achieves, the better their cardiopulmonary function.
Measured: 4 weeks
EG-5D-5L
Health-related quality of life, having 5 dimensions and 5 levels, plus a Visual Analogue Scale (EQ-VAS)
Measured: 4 weeks
WHO Quality of Life (WHOQOL)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jun 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
- Investigators
- József Dr. habil. Tollár, Principal investigator, Somogy County Kaposi Mór Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352085
- Sponsor's protocol ID
- IKEB2023/10
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exoskeleton-assisted Neurorehabilitation: Current Perspectives and Future Directions - A Pilot Study
- ClinicalTrials.gov ID
- NCT07352085
- Acronym / sponsor ID
- IKEB2023/10
- Conditions
- Stroke, Spinal Cord Injuries (Complete and Incomplete), Cerebellar Ataxia, Spastic Paraplegia
- Keywords
- Spinal cord injury, Ataxia, Stroke, Spastic paraplegia, Altered gait pattern, Eksobionics, Robotic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 20 Jan 2026 (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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ekso Group | Active comparator | Device: Gait training with exoskeletonImproving gait with the help of the Eksobionics EksoNR device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- confirmed diagnosis of spinal cord injury (at or below the C4 level)
- having cerebellar ataxia diagnosis
- confirmed spastic paraparesis
- ischemic stroke
Key exclusion criteria (26 listed)
- 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
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 |
|---|---|---|
| Gait training with exoskeletonEksoNR 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. | Device | Ekso Group |
Primary outcome
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.
Barthel Index (BI)
Time frame: 4 weeks
Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency.
7 secondary outcomes
Timed Up and Go (TUG)
Time frame: 4 weeks
Berg Balance Scale (BBS)
Time frame: 4 weeks
Tinetti
Time frame: 4 weeks
Walking Index for Spinal Cord Injury II. (WISCI II.)
Time frame: 4 weeks
6 minute walk test (6MWT)
Time frame: 4 weeks
EG-5D-5L
Time frame: 4 weeks
WHO Quality of Life (WHOQOL)
Time frame: 4 weeks
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 20 Jan 2026.
- Individual participant dataSharing planned: No
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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.
József Dr. habil. Tollár principal investigator
Somogy County Kaposi Mór Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training with exoskeleton in people with Stroke and Spinal Cord Injuries (Complete and Incomplete), run by Somogy Megyei Kaposi Mór Teaching Hospital 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 4 inclusion and 26 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 20 Jan 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?
Functional Independence Measure (FIM) (time frame: 4 weeks). The study lists 2 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 20 Jan 2026.