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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05134324
Other study ID # 22
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 25, 2021
Est. completion date May 25, 2022

Study information

Verified date November 2021
Source Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effect of rTMS and tDCS coupled with robotic therapy on upper extremity functional recovery


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 information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date May 25, 2022
Est. primary completion date February 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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


Related Conditions & MeSH terms


Intervention

Other:
active rTMS
Participants recevied 1 Hz low frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. Motor threshold was defined as the minimum stimulus intensity eliciting 5 responses of about 50 µV out of 10 consecutive trials (50% successful MEPS) in the relaxed contralateral abductor pollicis brevis (APB).The patient received robotic therapy for upper extremity just after each active TMS sessions.
sham rTMS
Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil employed was identical in shape and size to the real stimulation coil and produced no magnetic field. The patient received robotic therapy for upper extremity just after each sham TMS sessions.
active tDCS
Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions.The electrodes will be placed anodal to the C3/C4 (International 10/20 Electroencephalogram System) area, corresponding to the location of the affected hemisphere primary motor cortex (M1), and cathodal to the contralateral supraorbital region. The patient received robotic therapy for upper extremity just after each active tDCS sessions.
sham tDCS
Participants recevied sham stimulation were applied current was ramped up either over 10 seconds, with an equal amount of time for tapering off. The patient received robotic therapy for upper extremity just after each sham tDCS sessions

Locations

Country Name City State
Turkey Gaziler Physical Medicine and Rehabilitation Education and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Upper Extremity Fugl-Meyer Motor Function Scale Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome. initial, 3th week 9th week changes
Secondary Motor Activity Log-28 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. initial, 3th week 9th week changes
Secondary Barthel Index 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. initial, 3th week 9th week changes
Secondary Stroke Impact Scale version 3.0 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. initial, 3th week 9th week changes
Secondary Box and Block Test The Box and Block Test (BBT) measures unilateral gross manual dexterity. Higher values represent a better outcome. initial, 3th week 9th week changes
Secondary Modified Ashworth Scale Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome initial, 3th week 9th week changes
Secondary The amplitude of motor evoked potentials (MEPs) The amplitude of MEP is a common yet highly variable measure of corticospinal excitability. initial, 3th week 9th week changes
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