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

Not Applicable

Completed

• Conditions: Upper Limb Function in Subacute Hemiparetic Stroke Patients

• Registration Number: NCT06641518
• Lead Sponsor: Mahidol University

Brief Summary

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

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 Timeline

• Study Start: 2021-10-04
• Primary Completion: 2022-08-03
• Study Completion: 2022-10-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-12
• Study First Submitted QC: 2024-10-12
• Last Update Submitted: 2024-10-12
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment of upper extremity scores (FMA-UE)	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

Secondary Outcome Measures

Name	Time	Method
Wolf motor function test (WMFT)	baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.	measures upper extremity (UE) motor abilities
Box and block test (BBT)	baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.	measures unilateral gross manual dexterity
Modified functional reach test (FRT)	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.

Trial Locations

Locations (1)

Physical medicine and rehabilitation; 🇹🇭 Bangkok, Thailand