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Clinical Trials/NCT06641518
NCT06641518
Completed
N/A

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

Mahidol University1 site in 1 country18 target enrollmentOctober 4, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Upper Limb Function in Subacute Hemiparetic Stroke Patients
Sponsor
Mahidol University
Enrollment
18
Locations
1
Primary Endpoint
Fugl-Meyer Assessment of upper extremity scores (FMA-UE)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 4, 2021
End Date
October 1, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Songsuda Roongsaiwatana

Principal Investigator

Mahidol University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Wolf motor function test (WMFT)(baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.)
  • Box and block test (BBT)(baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.)
  • Modified functional reach test (FRT)(baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.)

Study Sites (1)

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