TENS for Limb Function in Stroke: Design and Rationale for a Randomized Trial

Not Applicable

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT06997744
• Lead Sponsor: CHENGNING Song

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Study Start: 2025-10-01
• Primary Completion: 2027-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fuyong People's Hospital, Bao'an District, Shenzhen; 🇨🇳 Shenzhen, Guangdong, China