Ataxia - OtherNCT07733687
Robotic Neurorehabilitation in Patients With Ataxia
A study testing Robot-Assisted Neurorehabilitation and Conventional Neurorehabilitation in people with Ataxia - Other, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial summary
This interventional study evaluates the effectiveness of robot-assisted neurorehabilitation in patients with ataxia. Participants will receive a structured robotic neurorehabilitation treatment program, and changes in motor function, coordination, balance, gait, and functional performance will be assessed using… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ataxia - Other
- What is being tested?
- Robot-Assisted Neurorehabilitation and Conventional Neurorehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 2 Jun 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults diagnosed with ataxia
- Age 18 years or older
- Ability to participate in a robot-assisted neurorehabilitation program
- Stable clinical condition allowing participation in rehabilitation treatment
- Ability to understand and follow study instructions
- Ability to complete the planned clinical and functional assessments
- Written informed consent provided by the participant
Who cannot join
- Severe cognitive impairment preventing cooperation with the intervention or assessments
- Severe musculoskeletal or neurological condition that prevents safe participation in robot-assisted rehabilitation
- Unstable cardiovascular, respiratory, or other medical condition contraindicating rehabilitation treatment
- Severe pain or orthopedic limitation preventing participation in the rehabilitation program
- Severe visual or vestibular impairment that would interfere with study assessments
- Acute medical condition or acute neurological deterioration at the time of enrollment
Show all 9Show fewer
- Participation in another interventional clinical study that could affect the study outcomes
- Pregnancy, if participation is considered unsafe by the investigator
- Any condition judged by the investigator to make participation unsafe or unsuitable
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: Assessment of the Effectiveness of Robotic Neurorehabilitation Treatment in Patients With Ataxia
This interventional study evaluates the effectiveness of robot-assisted neurorehabilitation in patients with ataxia. Participants will receive a structured robotic neurorehabilitation treatment program, and changes in motor function, coordination, balance, gait, and functional performance will be assessed using clinical outcome measures before and after the intervention.
Read the detailed description
Ataxia is a neurological condition characterized by impaired coordination, balance, gait, and motor control, which can significantly affect functional mobility and activities of daily living. Robot-assisted neurorehabilitation may provide intensive, repetitive, and task-specific training to support motor learning and functional improvement.
The purpose of this interventional study is to evaluate the effectiveness of robot-assisted neurorehabilitation treatment in patients with ataxia. Participants will undergo a structured neurorehabilitation program using robotic technology as part of their rehabilitation treatment. Clinical and functional assessments will be performed before and after the intervention to evaluate changes in motor function, coordination, balance, gait performance, and functional mobility.
- Conditions
- Ataxia - Other
- Being tested
- Robot-Assisted Neurorehabilitation, Conventional Neurorehabilitation
- Keywords
- Ataxia, Robot-Assisted Rehabilitation, Neurorehabilitation, Motor Function, Balance, Coordination, Functional Mobility
- Medical subject headings
- Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted NeurorehabilitationOther
Participants will receive robot-assisted neurorehabilitation as part of a structured rehabilitation program. The intervention will include repetitive, task-specific motor training using robotic technology, with the aim of improving coordination, balance, gait, motor function, and functional mobility in patients with ataxia.
Conventional NeurorehabilitationOther
Participants will receive conventional neurorehabilitation according to standard clinical practice. The intervention may include physiotherapy, balance training, coordination exercises, gait training, and functional mobility training.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Neurorehabilitation | Experimental | Participants in this arm will receive robot-assisted neurorehabilitation treatment aimed at improving motor function, coordination, balance, gait, and functional mobility in patients with ataxia. Receives: Other: Robot-Assisted Neurorehabilitation |
| Conventional Neurorehabilitation | Active comparator | Participants in this arm will receive conventional neurorehabilitation according to standard clinical practice. Outcomes will be assessed using the same clinical and functional measures as in the robot-assisted neurorehabilitation arm. Receives: Other: Conventional Neurorehabilitation |
| Control Group | No intervention | Participants in this arm will not receive robot-assisted neurorehabilitation as part of the study. They will undergo the planned clinical and functional assessments for comparison with the intervention arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARA (Scale for the Assessment and Rating of Ataxia)
The SARA (Scale for the Assessment and Rating of Ataxia) is a clinically validated tool used to quantify the severity of ataxia (coordination disorders) and to track the progression of patients over time.The scale consists of 8 tasks with a maximum total score of 40 points. A score of 0 indicates no ataxia, while 40 represents the most severe stage of ataxia.The 8 Items of the SARA Scale1. Gait (0-8 points): Assesses walking forward, turning, and tandem walking.2. Stance (0-6 points): Measures stability with feet apart, feet together, and in tandem stance.3. Sitting (0-4 points): Evaluates balance on a solid surface with eyes open and arms hanging loosely.4. Speech disturbance / Dysarthria (0-4 points): Rates the clarity and rhythm of speech during standard conversation.5. Finger-to-nose test (0-4 points): Measures movement accuracy and tremor for each arm separately.6. Finger-to-finger test (0-4 points): Assesses coordination as the patient repeatedly touches the clinician's finger.7
Measured: 6 months
Modified Rankin Scale
The Modified Rankin Scale (mRS) is a standard clinical tool used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological conditions.The Scale Grades (0-6 Points)0 - No symptoms at all: The patient feels completely normal with no residual effects.1 - No significant disability despite symptoms: Able to carry out all usual duties and activities.2 - Slight disability: Unable to carry out all previous activities, but able to look after own affairs without assistance.3 - Moderate disability: Requiring some help, but able to walk without assistance from another person.4 - Moderately severe disability: Unable to walk without assistance and unable to attend to own bodily needs without assistance.5 - Severe disability: Bedridden, incontinent, and requiring constant nursing care and attention.6 - Dead: The patient has passed away.
Measured: 6 month
Barthel Index
The Barthel Index (BI) is a widely used clinical scale that measures a patient's functional independence in performing 10 basic Activities of Daily Living (ADL). It is commonly used in stroke rehabilitation, geriatrics, and chronic care to assess self-care abilities and mobility.The total score ranges from 0 to 100 points (in increments of 5), where 0 represents complete dependence and 100 represents complete independence.The 10 Items of the Barthel Index1. Feeding (0, 5, 10 points): Ability to eat food when served (cutting, using utensils).2. Bathing (0, 5 points): Ability to wash oneself in a tub, shower, or sponge bath.3. Grooming (0, 5 points): Ability to wash hands/face, comb hair, shave, and clean teeth.4. Dressing (0, 5, 10 points): Ability to put on, fasten, and take off all clothing and shoes.5. Bowels (0, 5, 10 points): Control over bowel movements (no accidents, or requires assistance/enema).6. Bladder (0, 5, 10 points): Control over bladder function (dry day and night, or
Measured: 6 months
Secondary outcomes (3)
6-Minute Walk Test (6MWT)
The 6-Minute Walk Test (6MWT) is a simple, safe, and clinically standardized submaximal exercise test used to assess functional endurance and exercise capacity. Rather than testing maximum physical fitness, it measures the distance a patient can walk at a self-selected pace, reflecting their ability to perform everyday activities.It is widely used in patients with cardiovascular conditions (e.g., heart failure) and respiratory diseases (e.g., COPD, pulmonary fibrosis) to evaluate clinical status and therapeutic response.Test Protocol and ExecutionThe Core Task: The patient walks back and forth along a flat, hard, straight corridor (ideally 30 meters long with clear markings) for exactly 6 minutes.The Pace: The patient walks at their own quickest comfortable pace. They are allowed to slow down or stop to rest if needed, but the timer continues to run.Measured Parameters:Total distance walked in meters (the primary outcome).Pre-test and post-test heart rate and oxygen saturation (SpO2).
Measured: 6 months
Posturography
The Posturography exam (or simply Posturography) is an objective clinical assessment used to quantify a patient's balance, postural stability, and equilibrium. It is highly effective in evaluating disorders of the vestibular system (inner ear), neurological pathways, and musculoskeletal control.While static posturography uses a fixed platform, Computerized Dynamic Posturography (CDP) is the gold standard, testing how well a patient uses visual, somatosensory (touch/pressure), and vestibular cues to maintain balance.
Measured: 6 months
Functional Independence Measure (FIM)
The Functional Independence Measure (FIM) is an assessment tool used to measure a patient's level of disability and the amount of assistance they require to perform basic daily activities. It is widely utilized in inpatient rehabilitation settings to track progress from admission to discharge.The FIM evaluates 18 items divided into two main domains: Motor (13 items) and Cognitive (5 items). Each item is scored on a 7-point scale, making the total score range from 18 to 126 points.The 7-Point Scoring System7 - Complete Independence: Safe, timely, no assistive devices.6 - Modified Independence: Uses assistive devices, takes extra time, or has safety considerations.5 - Supervision or Setup: Requires standby assistance, cueing, or setup without physical contact.4 - Minimal Assistance: Patient performs 75% or more of the task.3 - Moderate Assistance: Patient performs 50% to 74% of the task.2 - Maximal Assistance: Patient performs 25% to 49% of the task.1 - Total Assistance: Patient perform
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start2 Jun 2026
- Primary completion2 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ataxia - OtherStudies 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
- Single group
- Model description
- All participants will receive robot-assisted neurorehabilitation treatment. Outcomes will be assessed before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733687
- Sponsor's protocol ID
- IKEB/2025/011
- Other IDs
- IKEB/2025/011
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Robotic Neurorehabilitation Treatment in Patients With Ataxia
- ClinicalTrials.gov ID
- NCT07733687
- Acronym / sponsor ID
- IKEB/2025/011
- Conditions
- Ataxia - Other
- Keywords
- Ataxia, Robot-Assisted Rehabilitation, Neurorehabilitation, Motor Function, Balance, Coordination, Functional Mobility
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 2 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 Jul 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.
This interventional study evaluates the effectiveness of robot-assisted neurorehabilitation in patients with ataxia. Participants will receive a structured robotic neurorehabilitation treatment program, and changes in motor function, coordination, balance, gait, and functional performance will be assessed using clinical outcome measures before and after the intervention.
Detailed description
Ataxia is a neurological condition characterized by impaired coordination, balance, gait, and motor control, which can significantly affect functional mobility and activities of daily living. Robot-assisted neurorehabilitation may provide intensive, repetitive, and task-specific training to support motor learning and functional improvement.
The purpose of this interventional study is to evaluate the effectiveness of robot-assisted neurorehabilitation treatment in patients with ataxia. Participants will undergo a structured neurorehabilitation program using robotic technology as part of their rehabilitation treatment. Clinical and functional assessments will be performed before and after the intervention to evaluate changes in motor function, coordination, balance, gait performance, and functional mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants will receive robot-assisted neurorehabilitation treatment. Outcomes will be assessed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Neurorehabilitation | Experimental | Other: Robot-Assisted NeurorehabilitationParticipants in this arm will receive robot-assisted neurorehabilitation treatment aimed at improving motor function, coordination, balance, gait, and functional mobility in patients with ataxia. |
| Conventional Neurorehabilitation | Active comparator | Other: Conventional NeurorehabilitationParticipants in this arm will receive conventional neurorehabilitation according to standard clinical practice. Outcomes will be assessed using the same clinical and functional measures as in the robot-assisted neurorehabilitation arm. |
| Control Group | No intervention | –Participants in this arm will not receive robot-assisted neurorehabilitation as part of the study. They will undergo the planned clinical and functional assessments for comparison with the intervention arm. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults diagnosed with ataxia
- Age 18 years or older
- Ability to participate in a robot-assisted neurorehabilitation program
- Stable clinical condition allowing participation in rehabilitation treatment
- Ability to understand and follow study instructions
Key exclusion criteria (9 listed)
- Severe cognitive impairment preventing cooperation with the intervention or assessments
- Severe musculoskeletal or neurological condition that prevents safe participation in robot-assisted rehabilitation
- Unstable cardiovascular, respiratory, or other medical condition contraindicating rehabilitation treatment
- Severe pain or orthopedic limitation preventing participation in the rehabilitation program
- Severe visual or vestibular impairment that would interfere with study assessments
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 |
|---|---|---|
| Robot-Assisted NeurorehabilitationParticipants will receive robot-assisted neurorehabilitation as part of a structured rehabilitation program. The intervention will include repetitive, task-specific motor training using robotic technology, with the aim of improving coordination, balance, gait, motor function, and functional mobility in patients with ataxia. | Other | Robot-Assisted Neurorehabilitation |
| Conventional NeurorehabilitationParticipants will receive conventional neurorehabilitation according to standard clinical practice. The intervention may include physiotherapy, balance training, coordination exercises, gait training, and functional mobility training. | Other | Conventional Neurorehabilitation |
Primary outcome
SARA (Scale for the Assessment and Rating of Ataxia)
Time frame: 6 months
The SARA (Scale for the Assessment and Rating of Ataxia) is a clinically validated tool used to quantify the severity of ataxia (coordination disorders) and to track the progression of patients over time.The scale consists of 8 tasks with a maximum total score of 40 points. A score of 0 indicates no ataxia, while 40 represents the most severe stage of ataxia.The 8 Items of the SARA Scale1. Gait (0-8 points): Assesses walking forward, turning, and tandem walking.2. Stance (0-6 points): Measures stability with feet apart, feet together, and in tandem stance.3. Sitting (0-4 points): Evaluates balance on a solid surface with eyes open and arms hanging loosely.4. Speech disturbance / Dysarthria (0-4 points): Rates the clarity and rhythm of speech during standard conversation.5. Finger-to-nose test (0-4 points): Measures movement accuracy and tremor for each arm separately.6. Finger-to-finger test (0-4 points): Assesses coordination as the patient repeatedly touches the clinician's finger.7
Modified Rankin Scale
Time frame: 6 month
The Modified Rankin Scale (mRS) is a standard clinical tool used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological conditions.The Scale Grades (0-6 Points)0 - No symptoms at all: The patient feels completely normal with no residual effects.1 - No significant disability despite symptoms: Able to carry out all usual duties and activities.2 - Slight disability: Unable to carry out all previous activities, but able to look after own affairs without assistance.3 - Moderate disability: Requiring some help, but able to walk without assistance from another person.4 - Moderately severe disability: Unable to walk without assistance and unable to attend to own bodily needs without assistance.5 - Severe disability: Bedridden, incontinent, and requiring constant nursing care and attention.6 - Dead: The patient has passed away.
Barthel Index
Time frame: 6 months
The Barthel Index (BI) is a widely used clinical scale that measures a patient's functional independence in performing 10 basic Activities of Daily Living (ADL). It is commonly used in stroke rehabilitation, geriatrics, and chronic care to assess self-care abilities and mobility.The total score ranges from 0 to 100 points (in increments of 5), where 0 represents complete dependence and 100 represents complete independence.The 10 Items of the Barthel Index1. Feeding (0, 5, 10 points): Ability to eat food when served (cutting, using utensils).2. Bathing (0, 5 points): Ability to wash oneself in a tub, shower, or sponge bath.3. Grooming (0, 5 points): Ability to wash hands/face, comb hair, shave, and clean teeth.4. Dressing (0, 5, 10 points): Ability to put on, fasten, and take off all clothing and shoes.5. Bowels (0, 5, 10 points): Control over bowel movements (no accidents, or requires assistance/enema).6. Bladder (0, 5, 10 points): Control over bladder function (dry day and night, or
3 secondary outcomes
6-Minute Walk Test (6MWT)
Time frame: 6 months
Posturography
Time frame: 6 months
Functional Independence Measure (FIM)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Ataxia - Other
RecruitingEarly Phase 1
Aprepitant for the Treatment of CLIFAHDD
CLIFAHDD, Congenital Contractures of the Limbs and Face, Hypotonia, and Developmental Delay
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
At Home Use of Stimulation Suits for Managing MS Symptoms
Multiple Sclerosis, MS (Multiple Sclerosis)
Recruiting
Vibrotactile Balance Belt Effect on Improving Gait
Vestibular Hypofunction, Ataxia - Other
Not yet recruitingObservational study
Structural Validity and Inter-rater Reliabitiliy of the Ataxia Trunk, Lower And Upper Extremity Scale (ATLAS)
Ataxia, Cerebellar, Ataxia, Gait
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Neurorehabilitation and Conventional Neurorehabilitation in people with Ataxia - Other, 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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
SARA (Scale for the Assessment and Rating of Ataxia) (time frame: 6 months). The study lists 3 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 29 Jul 2026.