The Effects of rTMS and tDCS Copuled With Robotic Therapy In Patients With Stroke
- Conditions
- Chronic Stroke
- Interventions
- Other: active tDCSOther: sham rTMSOther: active rTMSOther: sham tDCS
- Registration Number
- NCT05134324
- Lead Sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Brief Summary
The purpose of this study is to assess the effect of rTMS and tDCS coupled with robotic therapy on upper extremity functional recovery
- Detailed Description
After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility requirements will be randomized into four groups in a 1:1 ratio to active rTMS, sham rTMS, active tDCS and sham tDCS.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- ischemic stroke with a disease interval of 6 months to 2 years
- aged based 18 years
- first stroke
- Mini mental test score ≥ 22
- upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS)≤2
- Shoulder, elbow and wrist muscle strength ≥ 2 according to Medical Research Council- MRC
- hemorrhagic stroke
- history of epilepsy
- a cardiac pacemaker
- pregnancy
- Fugl Meyer upper extremity assessment score ≥44
- history of previous stroke or ischemic attack
- neurological diseases other than stroke
- metallic implant in brain or scalp (including cochlear implant)
- previous brain surgery
- orthopedic disease that prevents upper extremity movements
- diagnosis of malignancy
- receiving robotic /TMS/tDCS treatments in the last 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description active tDCS active tDCS Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions. The patient received robotic therapy for upper extremity just after each active tDCS sessions sham rTMS sham rTMS Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil. The patient received robotic therapy for upper extremity just after each sham TMS sessions active rTMS active rTMS Participants recevied 1 Hz low frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. The patient received robotic therapy for upper extremity just after each active TMS sessions sham tDCS sham tDCS Participants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions
- Primary Outcome Measures
Name Time Method Upper Extremity Fugl-Meyer Motor Function Scale initial, 3th week 9th week changes Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome.
- Secondary Outcome Measures
Name Time Method Motor Activity Log-28 initial, 3th week 9th week changes Scale measures frequency of use and functionality level of the affected upper limb during daily activities (min-max: 0-5 points). Higher values represent a better outcome.
Stroke Impact Scale version 3.0 initial, 3th week 9th week changes Scale has 8 domains: strength, hand function, mobility, physical and instrumental activities of daily living, memory and thinking, communication, emotion, and social participation. Scores for each domain range from 0 to 100, and higher scores indicate a better Scores for each domain range from 0 to 100, and higher scores indicate a better. The scale also includes a question (item 50) to assess the patient's global perception of recovery. The respondent is asked to rate his or her percentage of recovery on a visual analog scale of 0 to 100, with 0 meaning no recovery and 100 meaning full recovery.
The amplitude of motor evoked potentials (MEPs) initial, 3th week 9th week changes The amplitude of MEP is a common yet highly variable measure of corticospinal excitability.
Box and Block Test initial, 3th week 9th week changes The Box and Block Test (BBT) measures unilateral gross manual dexterity. Higher values represent a better outcome.
Barthel Index initial, 3th week 9th week changes Scale measures performance in activities of daily living. The Index yields a total score out of 100 - the higher the score, the greater the degree of functional independence.
Modified Ashworth Scale initial, 3th week 9th week changes Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome
Trial Locations
- Locations (1)
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
🇹🇷Ankara, Turkey