Robotic Neurorehabilitation in Patients With Ataxia

NCT07733687 | Active Not Recruiting

• 1 other identifier: IKEB/2025/011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 clinical outcome measures before and after the intervention.

Conditions

Ataxia - Other

Keywords

Ataxia; Robot-Assisted Rehabilitation; Neurorehabilitation; Motor Function; Balance; Coordination; Functional Mobility

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  6 months

Secondary Outcomes (3)

• 6-Minute Walk Test (6MWT)

  6 months

• Posturography

  6 months

• Functional Independence Measure (FIM)

  6 months

Study Arms (3)

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.

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.

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.

Interventions

Robot-Assisted Neurorehabilitation OTHER

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.

Robot-Assisted Neurorehabilitation

Conventional Neurorehabilitation OTHER

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.

Conventional Neurorehabilitation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Somogy Megyei Kaposi Mór Teaching Hospital: lead

Study Sites (1)

Somogy County Kaposi Mór Teaching Hospital

Kaposvár, Somogy County, 7400, Hungary

Location

MeSH Terms

Conditions

Ataxia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Model Details: All participants will receive robot-assisted neurorehabilitation treatment. Outcomes will be assessed before and after the intervention.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 29, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): November 2, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-06

Locations

HU (1)