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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
TENS and Task-orientated training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Electrical stimulation, exercise, stroke , rehabilitation

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1. Bilateral TENS (Bi-TENS) group

Unilateral TENS (Uni-TENS) group

Arm Description

Subjects having bilateral electrical stimulation and task-orientated exercises

Subjects having unilateral TENS over their affected lower limb only, and task-oriented exercises

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 29, 2014
Last Updated
March 7, 2019
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02152813
Brief Title
Efficacy of Bilateral Stimulation With Task-oriented Training in Improving Lower Limb Motor Functions in Patients With Stroke
Acronym
RCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Electrical stimulation, exercise, stroke , rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Bilateral TENS (Bi-TENS) group
Arm Type
Active Comparator
Arm Description
Subjects having bilateral electrical stimulation and task-orientated exercises
Arm Title
Unilateral TENS (Uni-TENS) group
Arm Type
Placebo Comparator
Arm Description
Subjects having unilateral TENS over their affected lower limb only, and task-oriented exercises
Intervention Type
Behavioral
Intervention Name(s)
TENS and Task-orientated training
Intervention Description
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 Measure Information:
Title
Muscle strength of lower limb
Description
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.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Dynamic standing balance
Description
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.
Time Frame
4 years
Other Pre-specified Outcome Measures:
Title
Lower-extremity motor coordination
Description
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.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
ZIP/Postal Code
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29437598
Citation
Kwong PWH, Ng GYF, Chung RCK, Ng SSM. Bilateral Transcutaneous Electrical Nerve Stimulation Improves Lower-Limb Motor Function in Subjects With Chronic Stroke: A Randomized Controlled Trial. J Am Heart Assoc. 2018 Feb 8;7(4):e007341. doi: 10.1161/JAHA.117.007341.
Results Reference
derived

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

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