Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

Recruiting

Phase N/A Results N/A

Trial Description

The aim of the project is to compare the effects of unilateral hybrid therapy [unilateral robot-assisted therapy (RT)] + unilateral arm training (UAT)] and bilateral hybrid therapy [bilateral RT + bilateral arm training (BAT)] on motor function, daily function, mobility, life quality, and motor control strategy in stroke patients.

Conditions

Interventions

  • Unilateral Hybrid Intervention Procedure
    Intervention Desc: For the unilateral RT training, participants will practice with their affected arms following a unilateral training protocol of BMT for 45 minutes (Yang, et al., 2012). For the UAT training, participants will receive training of the affected UL in functional tasks with behavioral shaping for 45 minutes (Lin, Wu, et al., 2009).
    ARM 1: Kind: Experimental
    Label: Unilateral Hybrid Intervention Group
    Description: Participants will receive 6 weeks of bilateral RT training using the BMT and UAT training in each session.
  • Bilateral Hybrid Intervention Procedure
    Intervention Desc: For the bilateral RT training, patients will focus on training involving both arms using the BMT robot for 45 minutes. During the 45 minutes BAT training, participants will receive training in tasks focusing on bilateral symmetric or alternating movements of both ULs.
    ARM 1: Kind: Experimental
    Label: Bilateral Hybrid Intervention Group
    Description: Participants will receive 6 weeks of bilateral RT training using the BMT and BAT training in each session.
  • BMT robot Device
    ARM 1: Kind: Experimental
    Label: Unilateral Hybrid Intervention Group
    Description: Participants will receive 6 weeks of bilateral RT training using the BMT and UAT training in each session.
    ARM 2: Kind: Experimental
    Label: Bilateral Hybrid Intervention Group
    Description: Participants will receive 6 weeks of bilateral RT training using the BMT and BAT training in each session.
    ARM 3: Kind: Experimental
    Label: Robot-Assisted Training Group
    Description: Participants will receive 6 weeks of RT training using the BMT in each session.
  • Training Other
    ARM 1: Kind: Experimental
    Label: Unilateral Hybrid Intervention Group
    Description: Participants will receive 6 weeks of bilateral RT training using the BMT and UAT training in each session.
    ARM 2: Kind: Experimental
    Label: Bilateral Hybrid Intervention Group
    Description: Participants will receive 6 weeks of bilateral RT training using the BMT and BAT training in each session.
  • Robot-Assisted Training Procedure
    Intervention Desc: The RT intervention will be matched in duration and intensity with the hybrid interventions. Participants in the RT group will practice on the BMT with bilateral protocols for 90 minutes. The tasks will be tailored according to the level
    ARM 1: Kind: Experimental
    Label: Robot-Assisted Training Group
    Description: Participants will receive 6 weeks of RT training using the BMT in each session.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change scores of Fugl-Meyer assessment(FMA) baseline, 3 weeks, 6 weeks, 18 weeks No
Secondary Wolf Motor Function Test (WMFT) baseline, 6 weeks No
Secondary Change scores of Box and block test (BBT) baseline, 3 weeks, 6 weeks, 18 weeks No
Secondary Change scores of Action research arm test (ARAT) baseline, 3 weeks, 6 weeks No
Secondary Change scores of Medical Research Council scale (MRC) baseline, 3 weeks, 6 weeks No
Secondary Change scores of Modified Ashworth scale (MAS) baseline, 3 weeks, 6 weeks No
Secondary Change scores of Myoton baseline, 6 weeks No
Secondary Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI) baseline, 6 weeks No
Secondary Change scores of Functional independent measure (FIM) baseline, 3 weeks, 6 weeks No
Secondary Change scores of Stroke Impact Scale (SIS 3.0 version) baseline, 3 weeks, 6 weeks, 18 weeks No
Secondary Change scores of EuroQol Quality of Life Scale (EQ-5D) baseline, 6 weeks No
Secondary Change scores of Hand strength baseline, 3 weeks, 6 weeks No
Secondary Change scores of Motor activity log (MAL) baseline, 6 weeks, 18 weeks No
Secondary Change scores of ABILHAND Questionnaire baseline, 6 weeks, 18 weeks No
Secondary Change scores of 10-meter walking test baseline, 6 weeks No
Secondary Change scores of Nottingham Extended ADL Questionnaire (NEADL) baseline, 6 weeks, 18 weeks No
Secondary Change scores of Adelaide Activities Profile (AAP) baseline, 6 weeks No
Secondary Change scores of Accelerometer baseline, 6 weeks No
Secondary Change scores of kinematic analysis baseline, 6 weeks No
Secondary Change scores of Adverse effects baseline, 3 weeks, 6 weeks No
Secondary Change scores of Algometer baseline, 6 weeks No
Secondary Change scores of Revised Nottingham Sensory Assessment (rNSA) baseline, 6 weeks No

Sponsors