Effectiveness of TENs Combined With Task-Related Training on Upper Limb Function in Subacute Hemiparetic Stroke Patients

October 12, 2024 updated by: Songsuda Roongsaiwatana, Mahidol University

Effectiveness of Transcutaneous Electrical Nerve Stimulation Combined With Task-Related Training on Upper Limb Function in Subacute Hemiparetic Stroke Patients

To study the effectiveness of transcutaneous electrical nerve stimulation (TENS) combined with occupational therapy on restoring the function of the weakened limb in subacute stroke patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To study the effectiveness of transcutaneous electrical nerve stimulation (TENS) combined with occupational therapy on restoring the function of the weakened limb in subacute stroke patients.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Physical Medicine and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with a first-ever stroke, presenting with unilateral weakness and accompanying arm weakness, in the subacute phase (2 weeks - 6 months).
  • Able to follow commands and cooperate in an active training program.
  • Patients must consent to participate in the research project by signing a consent form.
  • Aged between 18 and 80 years.
  • Exhibiting mild to moderate muscle spasticity (Modified Ashworth Scale < 3).

Exclusion Criteria:

  • Patients with other neurological disorders, such as traumatic brain injury or spinal cord injury, or those experiencing severe complications from treatment.
  • Unable to tolerate the use of TENS.
  • Contraindications for using TENS, such as having a pacemaker or infected skin lesions.
  • Unstable or uncontrolled vital signs or other comorbidities.
  • Communication difficulties that prevent following commands or cooperating in training.
  • Participants who refuse or withdraw from the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TENS
Transcutaneous Electrical Nerve Stimulation (TENS) was applied to the brachial plexus at the supraclavicular fossa (Erb's point) and to the radial nerve between the biceps and triceps in the spiral groove. The frequency was set at 10 Hz, and the intensity was adjusted to a level that elicited sensation without causing pain or muscle twitching, for a duration of 45 minutes, five days a week, totaling 20 sessions over four weeks, combined with standard upper extremity conservative occupational therapy training.
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
a therapeutic modality employing electric current to relieve pain by activating peripheral nerves. The evolution of TENS units alongside technological advancements has led to user-friendly interfaces and enhanced portability, with units now small enough to be carried in a pocket.
Sham Comparator: Sham TENS
Transcutaneous Electrical Nerve Stimulation (TENS) on the affected arm according to the same treatment protocol as above; however, the device was not turned on, and no electrical current was delivered (Placebo).
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
a therapeutic modality employing electric current to relieve pain by activating peripheral nerves. The evolution of TENS units alongside technological advancements has led to user-friendly interfaces and enhanced portability, with units now small enough to be carried in a pocket.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment of upper extremity scores (FMA-UE)
Time Frame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wolf motor function test (WMFT)
Time Frame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
measures upper extremity (UE) motor abilities
baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
Box and block test (BBT)
Time Frame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
measures unilateral gross manual dexterity
baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
Modified functional reach test (FRT)
Time Frame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position.
baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Actual)

August 3, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

October 12, 2024

First Submitted That Met QC Criteria

October 12, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 12, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA.MURA2021/831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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