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

Active, not recruiting

Phase 1 Results N/A

Trial 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.

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.

Conditions

Interventions

  • TENS and Task-orientated training Behavioral
    Intervention Desc: 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:
    ARM 1: Kind: Experimental
    Label: 1. Bilateral TENS (Bi-TENS) group
    Description: Subjects having bilateral electrical stimulation and task-orientated exercises
    ARM 2: Kind: Experimental
    Label: Unilateral TENS (Uni-TENS) group
    Description: Subjects having unilateral TENS over their affected lower limb only, and task-oriented exercises

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Muscle strength of lower limb 4 years Yes
Secondary Dynamic standing balance 4 years Yes

Sponsors