Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke

Recruiting

Phase N/A 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 upper limb function 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 upper limb 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 upper limb function 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 upper limb functions.

Conditions

Interventions

  • Task-orientated training Behavioral
    Intervention Desc: Bi/Uni/Placebo TENS and Task-orientated training on upper limb
    ARM 1: Kind: Experimental
    Label: Bilateral TENS (Bi-TENS) group
    Description: All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral electrical stimulation
    ARM 2: Kind: Experimental
    Label: Unilateral TENS (uni-TENS) group
    Description: All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side
    ARM 3: Kind: Experimental
    Label: Placebo group
    Description: All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation
  • Transcutaneous electrical nerve stimulation (TENS) Device
    ARM 1: Kind: Experimental
    Label: Bilateral TENS (Bi-TENS) group
    Description: All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral electrical stimulation
    ARM 2: Kind: Experimental
    Label: Unilateral TENS (uni-TENS) group
    Description: All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side
  • Sham electrical nerve stimulation Device
    ARM 1: Kind: Experimental
    Label: Placebo group
    Description: All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl Meyer Assessment on Upper Extremity (FMA-UE) 2 years
Primary Action Research Arm Test (ARAT) 2 years
Primary Maximal Voluntary Contraction (MVC) 2 years
Primary Jacket Test (JT) 2 years
Secondary The range of motion (ROM) of upper limb joints 2 years
Secondary Motor Activity Log (MAL) 2 years
Secondary Chinese version of Community Integration Measure (CIM) 2 years

Sponsors