Stroke
Conditions
Brief summary
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.
Interventions
DEVICELow-frequency(2HZ) TENS
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.
DEVICEHigh-frequency(100HZ) TENS
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.
DEVICEPlacebo TENS
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.
Sponsors
CHENGNING Song
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 85 years 2. Clinical diagnosis of stroke (ischemic or hemorrhagic) within the past 10 days to 2 months 3. Presence of voluntary movement in the non-paretic arm and at least minimal antigravity movement in the paretic shoulder 4. At least 5 degrees of active wrist extension on the paretic side 5. Able to provide informed consent
Exclusion criteria
1. Uncontrolled medical, cardiovascular, or orthopedic conditions 2. Contraindications to TENS (e.g., implanted cardiac pacemaker, skin allergies) 3. Receptive aphasia preventing informed consent or cooperation 4. Significant peripheral neuropathy affecting upper limbs 5. Current participation in another clinical trial or drug study 6. Severe contractures in the shoulder, elbow, wrist, or fingers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | Baseline, Week 4, Week 8, 1-month follow-up, and 3-month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Manual Muscle Testing (MMT) for Wrist Flexion and Extension | Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up | Evaluates muscle strength on a 0-5 scale, where 0 indicates no muscle activity and 5 indicates normal strength. |
| Modified Ashworth Scale (MAS) for Wrist Flexor Spasticity | Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up | Measures resistance during passive muscle movement on a 0-4 scale to assess spasticity. |
| Lindmark Motor Score - Grasp Function Subscale | Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up | Assesses hand grasp function on a 0-3 scale based on ability to grip and hold a tennis ball. |
| Barthel Index | Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up | Evaluates independence in basic activities of daily living. Scores range from 0 to 100, with higher scores indicating greater independence. |
Countries
China
Contacts
Primary ContactBo Lei
Outcome results
None listed