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

Mahidol University

Status: Completed

Conditions: Upper Limb Function in Subacute Hemiparetic Stroke Patients

Treatments: Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06641518

COA.MURA2021/831

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups

TENS

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Sham TENS

Sham Comparator group

Description:

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).

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)