Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training

Completed

Phase N/A Results N/A

Trial Description

The purpose of this study is to compare the training effects of robot-assisted therapy focus on proximal part, distal part, or total segment of upper extremity, respectively.

Conditions

Interventions

  • Proximal robot-assisted therapy Device
    ARM 1: Kind: Experimental
    Label: proximal robot-assisted therapy
    Description: treatment programs will target to shoulder and elbow portions of upper extremity via the InMotion2 robotic system
  • Distal robot-assisted therapy Device
    ARM 1: Kind: Experimental
    Label: distal robot-assisted therapy
    Description: the InMotion3 robot system will be used to execute treatment programs focus on wrist movements. It includes three degrees of freedom to allow wrist flexion/extension, abduction/adduction, and pronation/supination.
  • Combined robot-assisted therapy Device
    ARM 1: Kind: Experimental
    Label: combined robot-assisted therapy
    Description: the InMotion2 and InMotion3 robotic system will be provided simultaneously to provide the whole arm movements without distinguish proximal or distal upper limb training.
  • Individualized intensive therapy Behavioral
    ARM 1: Kind: Experimental
    Label: individualized intensive therapy
    Description: individualized occupational therapy which is dose-match to robot-assisted therapy, based on task-oriented principle.

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, 2 weeks, 4 weeks No
Secondary Change scores of Box and block test (BBT) baseline, 2 weeks, 4 weeks No
Secondary Change scores of Action research arm test (ARAT) baseline, 2 weeks, 4 weeks No
Secondary Change scores of Medical Research Council scale (MRC) baseline, 2 weeks, 4 weeks No
Secondary Change scores of Modified Ashworth scale (MAS) baseline, 2 weeks, 4 weeks No
Secondary Change scores of Myoton baseline, 2 weeks, 4 weeks No
Secondary Change scores of Wolf Motor Function Test (WMFT) baseline, 2 weeks, 4 weeks No
Secondary Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI) baseline, 2 weeks, 4 weeks No
Secondary Change scores of Functional independent measure (FIM) baseline, 2 weeks, 4 weeks No
Secondary Change scores of Stroke Impact Scale (SIS 3.0 version) baseline, 2 weeks, 4 weeks No
Secondary Change scores of EuroQol Quality of Life Scale (EQ-5D) baseline, 2 weeks, 4 weeks No
Secondary Change scores of kinematic analysis baseline, 2 weeks, 4 weeks No
Secondary Change scores of Adverse effects baseline, 2 weeks, 4 weeks Yes
Secondary Change scores of Hand strength baseline, 2 weeks, 4 weeks No
Secondary Change scores of Motor activity log (MAL) baseline, 4 weeks No
Secondary Change scores of ABILHAND Questionnaire baseline, 4 weeks No
Secondary Change scores of 10-meter walking test baseline, 4 weeks No
Secondary Change scores of Nottingham Extended ADL Questionnaire (NEADL) baseline, 4 weeks No
Secondary Change scores of Adelaide Activities Profile (AAP) baseline, 4 weeks No
Secondary Change scores of Montreal Cognitive Assessment (MoCA) baseline, 4 weeks No
Secondary Change scores of Number stroop test baseline, 4 weeks No
Secondary Change scores of Accelerometer baseline, 4 weeks No
Secondary Change scores of Revised Nottingham Sensory Assessment (rNSA) baseline, 4 weeks No
Secondary Change scores of Algometer baseline, 4 weeks No

Sponsors