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

NCT06641518 | Completed

• 1 other identifier: COA.MURA2021/831
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Limb Function in Subacute Hemiparetic Stroke Patients

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment of upper extremity scores (FMA-UE)

  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

  baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.

Secondary Outcomes (3)

• 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 Arms (2)

TENS

EXPERIMENTAL

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.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Sham TENS

SHAM COMPARATOR

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).

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) 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; TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Physical medicine and rehabilitation

Bangkok, 10400, Thailand

Location

Related Publications (1)

• 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.

  PMID: 29794530 BACKGROUND

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 15, 2024
• Study Start: October 4, 2021
• Primary Completion: August 3, 2022
• Study Completion: October 1, 2022
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)