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This study tests whether slow or fast electrical nerve stimulation (TENS) works better to improve arm movement in people recovering from a stroke. Participants will receive TENS on their weak arm three times a week for eight weeks. The results will help find the best TENS setting to support stroke recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2Hz TENS Group | Experimental |
| |
| 100Hz TENS Group | Experimental |
| |
| Placebo TENS Group | Placebo Comparator |
| |
| No-treatment Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-frequency(2HZ) TENS | Device | Participants receive transcutaneous electrical nerve stimulation (TENS) at a frequency of 2Hz. The stimulation is delivered using surface electrodes placed on the affected upper limb. Each session lasts 30 minutes and is conducted three times per week for a total of 8 weeks. Intensity is gradually increased from 1 mA to 3 mA during each session. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | Assesses upper limb motor function in stroke patients, including shoulder, elbow, wrist, and hand movements. Scores range from 0 to 66, with higher scores indicating better motor function. | Baseline, Week 4, Week 8, 1-month follow-up, and 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Manual Muscle Testing (MMT) for Wrist Flexion and Extension | Evaluates muscle strength on a 0-5 scale, where 0 indicates no muscle activity and 5 indicates normal strength. | Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up |
| Modified Ashworth Scale (MAS) for Wrist Flexor Spasticity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Lei | Contact | +86 151 0755 0352 | szleidoctor@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuyong People's Hospital, Bao'an District, Shenzhen | Shenzhen | Guangdong | 529000 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| High-frequency(100HZ) TENS | Device | Participants receive TENS at a frequency of 100Hz using the same electrode placement and schedule as the 2Hz group. Sessions last 30 minutes, three times weekly for 8 weeks, with intensity increasing from 1 mA to 3 mA across the session. This group represents high-frequency stimulation. |
|
| Placebo TENS | Device | Participants use a TENS device identical in appearance to the active treatment units. The power light is on, but no electrical stimulation is delivered due to internal circuit disconnection. Sessions follow the same schedule and duration as the active groups. |
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Measures resistance during passive muscle movement on a 0-4 scale to assess spasticity. |
| Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up |
| Lindmark Motor Score - Grasp Function Subscale | Assesses hand grasp function on a 0-3 scale based on ability to grip and hold a tennis ball. | Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up |
| Barthel Index | Evaluates independence in basic activities of daily living. Scores range from 0 to 100, with higher scores indicating greater independence. | Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |