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

NCT ID: NCT03304340

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-25

Study Completion Date

2015-12-31

Brief Summary

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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. Such persons were compared with others who received SR alone in order to determine if the addition of TENS or FES resulted in earlier or more effective recovery.

Detailed Description

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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

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Acute Stroke Intervention

Keywords

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acute stroke,TENS ,posture stability, function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TENS+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.

Group Type EXPERIMENTAL

transcutaneous nerve stimulation (TENS)

Intervention Type 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)

Intervention Type 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.

FES + 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.

Group Type EXPERIMENTAL

functional electrical stimulation (FES)

Intervention Type 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.

standard rehabilitation (SR)

Intervention Type 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.

SR-only

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 .

Group Type ACTIVE_COMPARATOR

standard rehabilitation (SR)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jer-Junn Lun, PhD

Role: PRINCIPAL_INVESTIGATOR

School institute of Physical Therapy, National Taiwan University

Locations

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National Taiwan University Hospital

Taipei, Test2, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201409010RINC

Identifier Type: -

Identifier Source: org_study_id