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

NCT03304340 | Completed

• 1 other identifier: 201409010RINC
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Stroke Intervention

Keywords

acute stroke,TENS ,posture stability, function

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 2-week, 4-week after stroke

Secondary Outcomes (7)

• Modified Ashworth scale for affected ankle plantar-flexors spasticity measurement

  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

  baseline and 2-week, 4-week after stroke

• the Timed Up & Go (TUG) test for functional mobility ability

  baseline and 2-week, 4-week after stroke

• the 10-meters walking test (10MWT) for walking speed evaluation

  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)

  within 4 weeks from stroke onset

Study Arms (3)

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.

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.

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 .

Other: standard rehabilitation (SR)

Interventions

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.

FES + SR

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.

TENS+SR

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.

FES + SR; SR-only; TENS+SR

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Test2, test3, Taiwan

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jer-Junn Lun, PhD

  School institute of Physical Therapy, National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2017
• First Posted: October 9, 2017
• Study Start: March 25, 2015
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: October 9, 2017

Record last verified: 2017-09

Locations

TW (1)