Acute Stroke InterventionNCT03304340

Comparison the Effects of Early Functional Electrical Stimulation and Transcutaneous Electrical Nerves Stimulation in Functional and Motor Recovery for Acute Stroke Patients

A study testing functional electrical stimulation (FES), transcutaneous nerve stimulation (TENS) and standard rehabilitation (SR) in people with Acute Stroke Intervention, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to examine the outcomes of postural stability, activities of daily living function, and motor capacity of persons after stroke who received transcutaneous electrical nerves stimulation (TENS) or functional electrical stimulation (FES), in addition to SR, in the post-stroke acute phase. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Acute Stroke Intervention
What is being tested?: functional electrical stimulation (FES), transcutaneous nerve stimulation (TENS) and standard rehabilitation (SR)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteTaiwan
Study dates: 25 Mar 2015to 31 Dec 2015
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 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

The inclusion criteria:

the patient who suffer from first stroke was admitted to the stroke center of National Taiwan University Hospital (NTUH) within 3 days of onset
National Institutes of Health Stroke Scale (NIHSS) scores ranging from 5 to 25
totally activity of daily living independent before stroke onset;
between 40-80 years old;
stroke with unilateral hemiparesis lesions confirmed by magnetic resonance imaging (MRI) or computed tomography (CT), with vascular lesions verified by magnetic resonance angiography (MRA);
a cortical or subcortical infarction or hemorrhage;
no other peripheral or central nervous system dysfunction;
no active inflammation or pathologic changes in the joints;
no active medical problems.

The exclusion criteria:

medical conditions unrelated to the cerebrovascular accident but which had affected walking performance
other cognitive, emotional, or behavioral impairments that result in insufficient comprehension, understanding, or collaboration
medical problems potentially adversely affected by electric stimulation
had skin conditions, or had allergies etc.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Taiwan University Hospital
Taipei, Test2, test3

Other trials in Taiwan

About this study

Official title: Adding the Transcutaneous Electrical Nerves Stimulation for Acute Stroke Rehabilitation

Read the detailed description

Based on modern knowledge about the neuro-plastic changes that occur immediately after brain injuries, rehabilitation should be more effective when started soon after brain damaged. Besides, knowledge about one of the factors that determine efficacy of rehabilitation is the commencement of treatment, as well as on the time interval from stroke to initiate voluntary movement. Therefore, many studies had reported that the effectiveness of functional electrical stimulation (FES) and transcutaneous electrical nerves stimulation (TENS), which induce stimulation and the excitability, were widely applied in rehabilitation for patients with stroke. However, many investigations about the effects of FES or TENS on motor recovery for the stroke patients mainly focus on the chronic stage as well as compared each of two different kinds of stimulation separately. Hence the investigators will study the impacts of TENS and FES on the motor recovery for the stroke patients from the acute stage. Bedsides, the investigators also study that whether patients after stroke in the acute stage who received adding TENS experienced similar impacts on motor recovery to those who received adding FES.

This was a single-blind randomized control trial study. The study recruited 40 subjects from stroke center of National Taiwan Hospital (NTUH) within 3 days after first stroke onset. All subjects were in stable medically control and assigned randomly to 1 of 3 groups including (1)Functional electrical stimulation (FES) + standard rehabilitation (SR) ,(2) Transcutaneous electrical nerves stimulation (TENS) + SR or (3)SR only (control group).The application of FES and TENS was used for 30 minutes per day, 5 days per week for 2 weeks. The surface electrodes of two dual channels were applied on tibialis anterior and quadriceps for FES and TENS group. All groups received SR including neuro-facilitation and functional task training etc.

Outcome measurements were analyzed with repeated measure analysis of variance using SPSS to compare the main effects before, during, and after treatment, followed by post-hoc tests with Bonferroni correction to compare treatment effects among the 3 groups. For categorical variables, a X2 test was used. The significance level was set at 5% (2-tailed).

Conditions: Acute Stroke Intervention
Being tested: functional electrical stimulation (FES), transcutaneous nerve stimulation (TENS), standard rehabilitation (SR)
Keywords: acute stroke,TENS ,posture stability, function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

functional electrical stimulation (FES)Device
Two dual-channel stimulators (MEDTRONIC Respond Select；Empi Inc) were connected with a program timer to form one stimulating unit for functional electrical stimulation (FES). FES was delivered with 0.3-ms pulses at 30 Hz, maximum tolerance intensity about 20 to 30 mA to cause visible muscle contraction.
transcutaneous nerve stimulation (TENS)Device
Transcutaneous nerve stimulation (TENS) stimulator (BioTENS, Skylark Device \& Systems Co., Ltd,) was applied with 0.2 ms pulses, at 100 Hz in the constant mode within the subject'sensory level without muscle contraction, via (5 × 3.5 cm) electrodes attached to the motor points of quadriceps and tibialis anterior (TA) on the affected lower extremity.
standard rehabilitation (SR)Other
The standard rehabilitation (SR) program was a part of a regular intervention in stroke center. The activities of SR performed including neurodevelopment facilitation techniques, range of motion exercises and movement re-learning exercises etc.

Study groups in NCT03304340
Study group	Role	What they receive
TENS+SR	Experimental	For each participant in the transcutaneous nerve stimulation (TENS) group, standard rehabilitation (SR) in addition a TENS stimulator (BioTENS, Skylark Device \& Systems Co., Ltd) was applied with 0.2-ms pulses at 100 Hz in the constant mode within the subject's sensory level without muscle contraction via (5 × 3.5 cm) electrodes attached to the motor points of the tibia anterior (TA) and quadriceps muscles on the affected lower extremity. For the TENS group, the given electric stimulation treatment lasted for 30 min per session, once per day, 5 days a week, for 2 weeks. Receives: Device: transcutaneous nerve stimulation (TENS); Other: standard rehabilitation (SR)
FES + SR	Experimental	For each participant in the functional electrical stimulation (FES) group, standard rehabilitation (SR) in addition two dual-channel FES stimulators (MEDTRONIC Respond Select; EmpiInc) were used. The FES was delivered with 0.3-ms pulses at 30 pps and the stimulation intensity was set to the movement threshold to induce visible muscle contractions. For the FES group, the given electric stimulation treatment lasted for 30 min per session, once per day, 5 days a week, for 2 weeks. Receives: Device: functional electrical stimulation (FES); Other: standard rehabilitation (SR)
SR-only	Active comparator	All the participants received functional training and motor relearning physiotherapy treatment as early standard rehabilitation (SR) for 30 minutes per day, 5 days a week throughout the study. Subjects in the SR group received only SR . Receives: Other: standard rehabilitation (SR)

What is being measured

The primary outcome is the main question the study is designed to answer.

The score-change of the Functional Independence Measure (FIM) for activity of daily living function
The FIM with a maximum score of 116 was used to assess each patient's capacities in terms of ADL, which comprises 18 seven-level items and assesses dependence in self-care, sphincter management, transfer, locomotion, communication, social interaction and cognition.
Measured: baseline and 2-week, 4-week after stroke

Secondary outcomes (7)

Modified Ashworth scale for affected ankle plantar-flexors spasticity measurement
The Modified Ashworth Scale (MAS) measures muscle hypertonia with 5-level grades including 1) no increase in muscle tone; 2) slight increase giving a catch when part is moved in flexion or extension; 3) more marked increase in tone but only after part is easily flexed; 4) considerable increase in tone; and 5) passive movement is difficult and affected part is rigid in flexion or extension.
Measured: baseline and 2-week, 4-week after stroke
Maximum isometric voluntary contraction (MIVC) of hip flexors, knee extensors and ankle dorsiflexors for measuring the improvement of affected muscle strength
Maximum isometric voluntary contraction (MIVC) of the ankle quadriceps, dorsiflexor, plantarflexor muscles was recorded by handheld dynamometer in supine position.
Measured: baseline and 2-week, 4-week after stroke
the Timed Up & Go (TUG) test for functional mobility ability
the Timed Up and Go Test was used to measure the walking time. Patients went from sitting to standing, walked three meters at a fast, comfortable speed, turned around, walked back, and sat down again. The patients were allowed to use his/her own walking aids, but no physical assistance was given by the researcher or therapist. The patients were also allowed to practice one or two trials in order to comprehend the whole test procedure. The mean time (in seconds) across three trials was used as the walking time.
Measured: baseline and 2-week, 4-week after stroke
the 10-meters walking test (10MWT) for walking speed evaluation
Individual walks without assistance 10 meters and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration.
Measured: baseline and 2-week, 4-week after stroke
The number of days required to achieve 5-mins sitting motor milestones from the Postural Assessment Scale for Stroke Patients (PASS)
The first milestone was the ability to sit on the edge of the bed with the feet touching the floor without support > 5 minutes (PASS subtest: maintaining posture, sitting without support, grade 3).
Measured: within 4 weeks from stroke onset
The number of days required to achieve 1-mins standing motor milestones from the Postural Assessment Scale for Stroke Patients (PASS)
The second milestone was the ability to stand without support for longer than 1 minute (PASS subtest: maintaining posture, standing without support, grade 3)
Measured: within 4 weeks from stroke onset
The number of days required to achieve 50-m walking motor milestones
The third milestone involved walking on a level surface for a minimum of 50 m with/without an assistive device under supervision for safety.
Measured: within 4 weeks from stroke onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Mar 201531 Dec 2015

First posted9 Oct 2017
Study start25 Mar 2015
Primary completion31 Dec 2015
Study completion31 Dec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Stroke InterventionStudies of the same condition, open and under way.
More trials run by National Taiwan University HospitalThe 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03304340
Sponsor's protocol ID: 201409010RINC
Status last verified: Sep 2017
First submitted: 1 Oct 2017
Last updated: 9 Oct 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Stroke Intervention trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adding the Transcutaneous Electrical Nerves Stimulation for Acute Stroke Rehabilitation
ClinicalTrials.gov ID: NCT03304340
Acronym / sponsor ID: 201409010RINC
Conditions: Acute Stroke Intervention
Keywords: acute stroke,TENS ,posture stability, function
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: National Taiwan University HospitalUniversity, hospital or other
Study start: 25 Mar 2015 (actual)
Primary completion: 31 Dec 2015 (actual)
Study completion: 31 Dec 2015 (actual)
First posted: 9 Oct 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
TENS+SR	Experimental	Device: transcutaneous nerve stimulation (TENS), Other: standard rehabilitation (SR)For each participant in the transcutaneous nerve stimulation (TENS) group, standard rehabilitation (SR) in addition a TENS stimulator (BioTENS, Skylark Device \& Systems Co., Ltd) was applied with 0.2-ms pulses at 100 Hz in the constant mode within the subject's sensory level without muscle contraction via (5 × 3.5 cm) electrodes attached to the motor points of the tibia anterior (TA) and quadriceps muscles on the affected lower extremity. For the TENS group, the given electric stimulation treatment lasted for 30 min per session, once per day, 5 days a week, for 2 weeks.
FES + SR	Experimental	Device: functional electrical stimulation (FES), Other: standard rehabilitation (SR)For each participant in the functional electrical stimulation (FES) group, standard rehabilitation (SR) in addition two dual-channel FES stimulators (MEDTRONIC Respond Select; EmpiInc) were used. The FES was delivered with 0.3-ms pulses at 30 pps and the stimulation intensity was set to the movement threshold to induce visible muscle contractions. For the FES group, the given electric stimulation treatment lasted for 30 min per session, once per day, 5 days a week, for 2 weeks.
SR-only	Active comparator	Other: standard rehabilitation (SR)All the participants received functional training and motor relearning physiotherapy treatment as early standard rehabilitation (SR) for 30 minutes per day, 5 days a week throughout the study. Subjects in the SR group received only SR .

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
functional electrical stimulation (FES)Two dual-channel stimulators (MEDTRONIC Respond Select；Empi Inc) were connected with a program timer to form one stimulating unit for functional electrical stimulation (FES). FES was delivered with 0.3-ms pulses at 30 Hz, maximum tolerance intensity about 20 to 30 mA to cause visible muscle contraction.	Device	FES + SR
transcutaneous nerve stimulation (TENS)Transcutaneous nerve stimulation (TENS) stimulator (BioTENS, Skylark Device \& Systems Co., Ltd,) was applied with 0.2 ms pulses, at 100 Hz in the constant mode within the subject'sensory level without muscle contraction, via (5 × 3.5 cm) electrodes attached to the motor points of quadriceps and tibialis anterior (TA) on the affected lower extremity.	Device	TENS+SR
standard rehabilitation (SR)The standard rehabilitation (SR) program was a part of a regular intervention in stroke center. The activities of SR performed including neurodevelopment facilitation techniques, range of motion exercises and movement re-learning exercises etc.	Other	FES + SR, SR-only, TENS+SR

Primary outcome

The score-change of the Functional Independence Measure (FIM) for activity of daily living function
Time frame: baseline and 2-week, 4-week after stroke
The FIM with a maximum score of 116 was used to assess each patient's capacities in terms of ADL, which comprises 18 seven-level items and assesses dependence in self-care, sphincter management, transfer, locomotion, communication, social interaction and cognition.

7 secondary outcomes

Modified Ashworth scale for affected ankle plantar-flexors spasticity measurement
Time frame: baseline and 2-week, 4-week after stroke
Maximum isometric voluntary contraction (MIVC) of hip flexors, knee extensors and ankle dorsiflexors for measuring the improvement of affected muscle strength
Time frame: baseline and 2-week, 4-week after stroke
the Timed Up & Go (TUG) test for functional mobility ability
Time frame: baseline and 2-week, 4-week after stroke
the 10-meters walking test (10MWT) for walking speed evaluation
Time frame: baseline and 2-week, 4-week after stroke
The number of days required to achieve 5-mins sitting motor milestones from the Postural Assessment Scale for Stroke Patients (PASS)
Time frame: within 4 weeks from stroke onset
The number of days required to achieve 1-mins standing motor milestones from the Postural Assessment Scale for Stroke Patients (PASS)
Time frame: within 4 weeks from stroke onset
The number of days required to achieve 50-m walking motor milestones
Time frame: within 4 weeks from stroke onset

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 9 Oct 2017.

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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.

Jer-Junn Lun, PhD principal investigator

School institute of Physical Therapy, National Taiwan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 9 Oct 2017. 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 Taiwan. 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. 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?

The score-change of the Functional Independence Measure (FIM) for activity of daily living function (time frame: baseline and 2-week, 4-week after stroke). 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 NCT03304340.

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 9 Oct 2017.