A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training

Completed

Phase 1 Results

Trial Description

A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program.

Detailed Description

The objective of this study is to clinically assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program, and investigate the acceptance from patients and therapists. Total of 7 patients will be recruited in this study, all the patients will receive 1.5 hours of standard therapy together with 0.5 hour of robot therapy every day. The robot therapy will be a 30 mins long session for 3 to 5 days per week over a period of six weeks. The study will include forearm pronation-supination and wrist flexion-extension training.

Conditions

Interventions

  • Standard rehabilitation therapy Behavioral
    Intervention Desc: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
    ARM 1: Kind: Experimental
    Label: Robot group
    Description: Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
    ARM 2: Kind: Experimental
    Label: Control group
    Description: Receive 2 hours of daily standard rehabilitation therapy
  • Robot-assisted therapy for wrist and forearm Device
    Other Names: CR2-Haptic Rehabilitation Robot
    Intervention Desc: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
    ARM 1: Kind: Experimental
    Label: Robot group
    Description: Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy

Trial Design

  • Allocation: Non-Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Motor impairment of wrist and forearm Change from Baseline in motor impairment of wrist and forearm at week 6 and 12 No
Secondary Motor function assessment of hand movement Change from Baseline in motor function of hand function related to wrist and forearm at week 6 and 12 No
Secondary Wrist and forearm active range of movement (AROM) Change from Baseline in AROM of wrist and forearm at weeks 6 and 12 No
Secondary Wrist and forearm passive range of movement (PROM) Change from Baseline in PROM of wrist and forearm at weeks 6 and 12 No
Secondary Spasticity level of wrist and forearm Change from Baseline in spasticity level of wrist and forearm at week 6 and 12 No
Secondary Spasticity Level of Wrist Spasticity level of wrist at week 6 No
Secondary Forearm's Active Range of Movement Active range of motion of forearm at week 6 No
Secondary Forearm's Passive Range of Motion Passive range of motion of forearm at week 6 No
Secondary Wrist's Passive Range of Motion Passive range of motion of wrist at week 6 No
Secondary Wrist's Active Range of Motion Active range of motion of wrist at week 6 No

Sponsors