NCT02152813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

3.7 years

First QC Date

May 29, 2014

Last Update Submit

March 7, 2019

Conditions

Stroke

Keywords

Electrical stimulation, exercise, stroke , rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Dynamic standing balance

    4 years

Other Outcomes (1)

  • Lower-extremity motor coordination

    4 years

Study Arms (2)

1. Bilateral TENS (Bi-TENS) group

ACTIVE COMPARATOR

Subjects having bilateral electrical stimulation and task-orientated exercises

Behavioral: TENS and Task-orientated training

Unilateral TENS (Uni-TENS) group

PLACEBO COMPARATOR

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

Behavioral: TENS and Task-orientated training

Interventions

TENS and Task-orientated trainingBEHAVIORAL

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:

1. Bilateral TENS (Bi-TENS) groupUnilateral TENS (Uni-TENS) group

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 29437598DERIVED

MeSH Terms

Conditions

StrokeMotor Activity

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 2, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 8, 2019

Record last verified: 2019-03

Locations

HK(1)