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Efficacy of Bilateral Stimulation With Task-oriented Training in Improving Lower Limb Motor Functions in Patients With Stroke (RCT)

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ClinicalTrials.gov Identifier: NCT02152813
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Shamay Ng, The Hong Kong Polytechnic University

Brief Summary:

This proposed study aims to compare the effects of unilateral and bilateral transcutaneous electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS + task-oriented training (TOT) with unilateral TENS+TOTin improving muscle strength, co-ordination, dynamic standing balance, walking performance, and functional mobility in patients with chronic stroke.

The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not significantly different in promoting the recovery of these functions.


Condition or disease Intervention/treatment Phase
Stroke Behavioral: TENS and Task-orientated training Not Applicable

Detailed Description:

This proposed study aims to compare the effects of unilateral and bilateral transcutaneous electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS + task-oriented training (TOT) with unilateral TENS+TOTin improving muscle strength, co-ordination, dynamic standing balance, walking performance, and functional mobility in patients with chronic stroke.

The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not significantly different in promoting the recovery of these functions.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Bilateral Stimulation With Task-oriented Training in Improving Lower Limb Motor Functions in Patients With Stroke: a Randomized, Placebo-controlled Clinical Trial
Actual Study Start Date : May 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Arm Intervention/treatment
Active Comparator: 1. Bilateral TENS (Bi-TENS) group
Subjects having bilateral electrical stimulation and task-orientated exercises
Behavioral: TENS and Task-orientated training
All subjects will undergo 16 sessions of their assigned intervention (60 minutes, twice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented lower limb training (TOT) with electrical stimulation protocol assigned concurrently:

Placebo Comparator: Unilateral TENS (Uni-TENS) group
Subjects having unilateral TENS over their affected lower limb only, and task-oriented exercises
Behavioral: TENS and Task-orientated training
All subjects will undergo 16 sessions of their assigned intervention (60 minutes, twice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented lower limb training (TOT) with electrical stimulation protocol assigned concurrently:




Primary Outcome Measures :
  1. Muscle strength of lower limb [ Time Frame: 4 years ]
    The strength of maximum isometric voluntary contraction of the subject's knee extensors and flexors, ankle dorsiflexors, and plantarflexors (in kilograms) will be measured bilaterally using a Nicholas handheld dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN) with standardized testing positions and dynamometer placement. Good to excellent reliability (ICC range, 0.84 -0.99) has been reported for lower-limb hand-held dynamometer strength measurements of subjects with neurologic conditions [49]. Each subject will complete three trials in which maximal force is generated for 2 to 3 seconds ffrom each muscle. The average of the three readings will be used for data analysis.


Secondary Outcome Measures :
  1. Dynamic standing balance [ Time Frame: 4 years ]
    The step test (ST) will be used to measure dynamic standing balance of both the paretic and normal limbs. It measures the number of times a subject is able to place one foot on a step 7.5cm high and back to the ground, as fast as possible, within 15 seconds. Three trials will be performed with each leg, with 1 minute of rest between trials to minimize fatigue. ST scores show excellent intra-rater and inter-rater reliability with subjects with chronic stroke.


Other Outcome Measures:
  1. Lower-extremity motor coordination [ Time Frame: 4 years ]
    The lower-extremity motor coordination test (LEMOCOT) will be used to measure the coordination of both the paretic and normal legs [50]. The LEMOCOT has been demonstrated as having good reliability (ICC=0.83-0.88) for subjects with subacute stroke [50]. Two red flat targets will be secured on the floor 30cm apart. The test will be performed while the subject is seated on a chair without armrests, with the knees flexed at close to 90o, the feet resting flat on the floor, and the heels on one of the targets. The subject will be instructed to touch the 2 targets alternately with the big toe, as quickly and as accurately as possible, for 20 seconds. The number of times each target is touched will be counted. The first trial will be a practice trial, with the average of the second and third trials used for analysis.



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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects will be recruited from local self-help groups through poster advertising. \
  • Subjects will be included if they (1) are between 55 and 85 years of age
  • Have been diagnosed with ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography within the previous 1 to 10 years
  • Are able to walk 3 metres independently with or without a walking aid
  • Are able to score > 6 out of 10 on the abbreviated mental test
  • Are able to follow instructions and give informed consent
  • Have no skin allergy which would prevent electrical stimulation.

Exclusion Criteria:

  • Subjects will be excluded if they have any additional medical, cardiovascular or orthopedic condition that would hinder proper treatment or assessment
  • Use a cardiac pacemaker
  • Have receptive dysphasia
  • Have significant lower limb peripheral neuropathy (e.g. diabetic polyneuropathy)
  • Are involved in drug studies or other clinical trials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152813


Locations
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Hong Kong
The Hong Kong Polytechnic University
Hong Kong, Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shamay Ng, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02152813     History of Changes
Other Study ID Numbers: 2014_GRF_NG
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shamay Ng, The Hong Kong Polytechnic University:
Electrical stimulation, exercise, stroke , rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases