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

The Hong Kong Polytechnic University

Status: Completed

Conditions: Stroke

Treatments: Behavioral: TENS and Task-orientated training

Study type: Interventional

Funder types: Other

Identifiers

NCT02152813

2014_GRF_NG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

1. Bilateral TENS (Bi-TENS) group

Active Comparator group

Description:

Subjects having bilateral electrical stimulation and task-orientated exercises

Treatment:

Behavioral: TENS and Task-orientated training

Unilateral TENS (Uni-TENS) group

Placebo Comparator group

Description:

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

Treatment:

Behavioral: TENS and Task-orientated training