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
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
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Bangkok, Thailand, 10400
- Physical Medicine and Rehabilitation
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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.
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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.
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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).
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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.
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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
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baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
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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.
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measures upper extremity (UE) motor abilities
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baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
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Box and block test (BBT)
Time Frame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
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measures unilateral gross manual dexterity
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baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
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Modified functional reach test (FRT)
Time Frame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
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a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position.
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baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
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