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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06641518
Enrollment
18
Registered
2024-10-15
Start date
2021-10-04
Completion date
2022-10-01
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Limb Function in Subacute Hemiparetic Stroke Patients

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.

Interventions

DEVICETranscutaneous 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.

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026