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Completed

NCT Number: NCT02152813

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

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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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Vascular Diseases

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TENS and Task-orientated training

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Acronym: RCT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 2, 2014
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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