Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke "ARTHE"

Not yet recruiting

Phase N/A Results N/A

Trial Description

The purpose of this pilot study is to investigate the clinical effects of a new upper limb robot assisted therapy device that is linked to a virtual therapy environment in patients with stroke.

Detailed Description

The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.
In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.

Conditions

Interventions

  • Training with new upper limb robot assisted therapy device Device
    Other Names: active orthosis; exoskeleton
    Intervention Desc: During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
    ARM 1: Kind: Experimental
    Label: Training with the device
    Description: Training with new upper limb robot assisted therapy device

Trial Design

  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Supportive Care
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer test upper limb section Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks No
Primary Medical research council score Change from baseline Medical research council score at 8 weeks and 12 weeks No
Primary Active range of motion of the elbow joint Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks No
Primary Passive range of motion of the elbow joint Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks No
Primary Modified Ashworth Scale Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks No
Secondary ABILHAND questionnaire Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks No
Secondary Functional independence measure Change from baseline Functional independence measure score at 8 weeks and 12 weeks No
Secondary Stroke impact scale Change from baseline Stroke impact scale score at 8 weeks and 12 weeks No
Secondary Intrinsic motivation inventory Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks No

Sponsors