NCT06997744

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable stroke

Timeline
30mo left

Started Oct 2025

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Oct 2025Sep 2028

First Submitted

Initial submission to the registry

May 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

May 21, 2025

Last Update Submit

August 22, 2025

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Manual Muscle Testing (MMT) for Wrist Flexion and Extension

    Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up

  • Modified Ashworth Scale (MAS) for Wrist Flexor Spasticity

    Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up

  • Lindmark Motor Score - Grasp Function Subscale

    Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up

  • Barthel Index

    Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up

Study Arms (4)

2Hz TENS Group

EXPERIMENTAL
Device: Low-frequency(2HZ) TENS

100Hz TENS Group

EXPERIMENTAL
Device: High-frequency(100HZ) TENS

Placebo TENS Group

PLACEBO COMPARATOR
Device: Placebo TENS

No-treatment Control Group

NO INTERVENTION

Interventions

Low-frequency(2HZ) TENSDEVICE

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.

2Hz TENS Group
High-frequency(100HZ) TENSDEVICE

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.

100Hz TENS Group
Placebo TENSDEVICE

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.

Placebo TENS Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 85 years
  • Clinical diagnosis of stroke (ischemic or hemorrhagic) within the past 10 days to 2 months
  • Presence of voluntary movement in the non-paretic arm and at least minimal antigravity movement in the paretic shoulder
  • At least 5 degrees of active wrist extension on the paretic side
  • Able to provide informed consent

You may not qualify if:

  • Uncontrolled medical, cardiovascular, or orthopedic conditions
  • Contraindications to TENS (e.g., implanted cardiac pacemaker, skin allergies)
  • Receptive aphasia preventing informed consent or cooperation
  • Significant peripheral neuropathy affecting upper limbs
  • Current participation in another clinical trial or drug study
  • Severe contractures in the shoulder, elbow, wrist, or fingers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuyong People's Hospital, Bao'an District, Shenzhen

Shenzhen, Guangdong, 529000, China

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Central Study Contacts

Bo Lei

CONTACT

+86 151 0755 0352szleidoctor@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 30, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2028

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

CN(1)