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

Not Applicable
Completed
Conditions
Stroke
Registration Number
NCT02152813
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Muscle strength of lower limb4 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
NameTimeMethod
Dynamic standing balance4 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.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University

🇭🇰

Hong Kong, Hong Kong

The Hong Kong Polytechnic University
🇭🇰Hong Kong, Hong Kong

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