Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke "MyoReArm"

Completed

Phase 1 Results N/A

Trial Description

The aim of this study is to assess the clinical effectiveness of the RehaARM-robot and to determine the feasibility of including robotic therapy in daily rehabilitation programmes, after stroke. Additionally, we aim to investigate the acceptance of this intervention from patients and therapists. A total of 10 patients will be recruited in this study, all the patients will receive 1 hour of standard therapy together with 45 min of robot therapy every day. The robot therapy will last 45 minutes, for 15 consecutive days within a maximum period of four weeks. Additional 15 minutes are required for placing surface electrodes on the shoulder and patient preparation. The study will include passive and active shoulder training of four movements: Horizontal abduction/adduction, abduction/adduction, internal/external rotation and flexion/extension. The passive part lasts 10 minutes and the active part 35 minutes.

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: The RehaARM-Robot
    Description: Receive 45 min of robot-assisted therapy for the shoulder and 1 hour of daily standard rehabilitation therapy.
  • The RehaARM-Robot Device
    Other Names: Robot-assisted therapy for the shoulder
    Intervention Desc: Robot therapy by using a 3-Degrees-Of-Freedom (3DOFs) robot to train the shoulder.
    ARM 1: Kind: Experimental
    Label: The RehaARM-Robot
    Description: Receive 45 min of robot-assisted therapy for the shoulder and 1 hour of daily standard rehabilitation therapy.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment scale - Upper Extremity (FMA-UE) 3 weeks (15 sessions) No
Secondary Functional Independence Measure (FIM) 3 weeks (15 sessions) Yes
Secondary Reaching Performance Scale (RPS) 3 weeks (15 sessions) No
Secondary Modified Ashworth Scale (MAS) of five muscles 3 weeks (15 sessions) No
Secondary Nine Hole Pegboard Test (NHPT) 3 weeks (15 sessions) No

Sponsors