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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Bilateral Stimulation With Task-oriented Training in Improving Lower Limb Motor Functions in Patients With Stroke: a Randomized, Placebo-controlled Clinical Trial

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: TENS and Task-orientated training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Bilateral TENS (Bi-TENS) group<br>Subjects having bilateral electrical stimulation and task-orientated exercises | Behavioral: TENS and Task-orientated training<br>* 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:<br>|
| Placebo Comparator: Unilateral TENS (Uni-TENS) group<br>Subjects having unilateral TENS over their affected lower limb only, and task-oriented exercises | Behavioral: TENS and Task-orientated training<br>* 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:<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength of lower limb | 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. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic standing balance | 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. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical stimulation, exercise, stroke , rehabilitation