Ataxia - Other
Conditions
Keywords
Ataxia, Robot-Assisted Rehabilitation, Neurorehabilitation, Motor Function, Balance, Coordination, Functional Mobility
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.
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.
Interventions
OTHERRobot-Assisted Neurorehabilitation
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.
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.
Sponsors
Somogy Megyei Kaposi Mór Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will receive robot-assisted neurorehabilitation treatment. Outcomes will be assessed before and after the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARA (Scale for the Assessment and Rating of Ataxia) | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-Minute Walk Test (6MWT) | 6 months | 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). |
| Posturography | 6 months | 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. |
| Functional Independence Measure (FIM) | 6 months | 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 |
Countries
Hungary
Outcome results
None listed