Upper Limb Function in Subacute Hemiparetic Stroke PatientsNCT06641518
Effectiveness of TENs Combined With Task-Related Training on Upper Limb Function in Subacute Hemiparetic Stroke Patients
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Upper Limb Function in Subacute Hemiparetic Stroke Patients, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Function in Subacute Hemiparetic Stroke Patients
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteThailand
- Study dates
- 4 Oct 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Transcutaneous Electrical Nerve Stimulation 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.
Read the 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.
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
Secondary outcomes (3)
Wolf motor function test (WMFT)
measures upper extremity (UE) motor abilities
Measured: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
Box and block test (BBT)
measures unilateral gross manual dexterity
Measured: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
Modified functional reach test (FRT)
a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position.
Measured: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start4 Oct 2021
- Primary completion3 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Limb Function in Subacute Hemiparetic Stroke PatientsStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songsuda Roongsaiwatana, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641518
- Sponsor's protocol ID
- COA.MURA2021/831
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29794530
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcutaneous Electrical Nerve Stimulation Combined With Task-Related Training on Upper Limb Function in Subacute Hemiparetic Stroke Patients
- ClinicalTrials.gov ID
- NCT06641518
- Acronym / sponsor ID
- COA.MURA2021/831
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)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. |
| Sham TENS | Sham comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous 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. | Device | Sham TENS, TENS |
Primary outcome
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
3 secondary outcomes
Wolf motor function test (WMFT)
Time frame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
Box and block test (BBT)
Time frame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
Modified functional reach test (FRT)
Time frame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 29794530Carrico 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Upper Limb Function in Subacute Hemiparetic Stroke Patients, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment of upper extremity scores (FMA-UE) (time frame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06641518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.