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

NCT ID: NCT06641518

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2022-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Upper Limb Function in Subacute Hemiparetic Stroke Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type DEVICE

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 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).

Group Type SHAM_COMPARATOR

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Songsuda Roongsaiwatana

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Physical medicine and rehabilitation

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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Carrico C, Westgate PM, Salmon Powell E, Chelette KC, Nichols L, Pettigrew LC, Sawaki L. Nerve Stimulation Enhances Task-Oriented Training for Moderate-to-Severe Hemiparesis 3-12 Months After Stroke: A Randomized Trial. Am J Phys Med Rehabil. 2018 Nov;97(11):808-815. doi: 10.1097/PHM.0000000000000971.

Reference Type BACKGROUND
PMID: 29794530 (View on PubMed)

Other Identifiers

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COA.MURA2021/831

Identifier Type: -

Identifier Source: org_study_id

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