Physical medicine and rehabilitation
Bangkok, 10400, Thailand
Completed
NCT Number: NCT06641518
Effectiveness of TENs Combined With Task-Related Training on Upper Limb Function in Subacute Hemiparetic Stroke Patients
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.
Completed
Looking for future studies?
Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Transcutaneous Electrical Nerve Stimulation (TENS)
Devicea 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.
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)
Time frame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
measures upper extremity (UE) motor abilities
-
Box and block test (BBT)
Time frame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
measures unilateral gross manual dexterity
-
Modified functional reach test (FRT)
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Mahidol University
Other
Registry information
Official study title
Effectiveness of Transcutaneous Electrical Nerve Stimulation Combined With Task-Related Training on Upper Limb Function in Subacute Hemiparetic Stroke Patients
Important dates
- Study start
- 2021
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Oct 15, 2024
- Registry last updated
- Oct 15, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.