Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

Completed

Phase N/A Results N/A

Trial Description

The aim of this project is to clinically evaluate a novel robot-assisted therapeutic approach to train sensorimotor hand function after stroke. It combines the profound experience of the clinic Hildebrand in neurocognitive therapy - involving brain and mind in the task and training both the motor and the sensory system - with the advanced haptic robotic technology of the Rehabilitation Engineering Lab at the Swiss Federal Institute of Technology Zurich (ETH Zurich), allowing unmet interaction with the hand through the simulation of virtual objects with various mechanical properties. In a randomized controlled clinical trial, 10 sub-acute stroke patients will receive four weeks of robotic therapy sessions, integrated seamlessly into their daily rehabilitation program, while 10 other patients will receive conventional therapy. The investigators will assess baseline performance in an initial clinical and robotic assessment, with another assessment at the end of the four-week period, and in follow-ups four weeks and six months later. The contents of the patient-tailored robotic therapy sessions will match those of the conventional therapy as closely as possible. This study will demonstrate the feasibility of including robotic therapy of hand function into the daily rehabilitation program, and investigate the acceptance from patients and therapists. The investigators expect increased training intensity during the robotic therapy session compared to conventional sessions with similar contents, as well as novel insights into the recovery process of both the motor and the sensory system during the four weeks of therapy, through advanced robotic assessments integrated into the training sessions. This project is a first step towards making such robotic therapy available to patients as integration into the conventional individual therapy program (e.g. for self-training), and towards transferring this technology to the home environment.

Conditions

Interventions

  • Robot-assisted neurocognitive therapy of hand function Device
    Other Names: Rehabilitation robot ReHapticKnob
    Intervention Desc: 2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.
    ARM 1: Kind: Experimental
    Label: Robot group
    Description: Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy. (4 x 45 min/week)
  • Conventional neurocognitive rehabilitation Other
    Other Names: Perfetti-concept
    Intervention Desc: Use sensory perception (tactile, proprioception but not vision!) to solve a by the therapist guided (passive) or patient controlled (active) therapy task, e.g. discrimination/identification of different spring resistances, sponges, different sized blocks, etc.
    ARM 1: Kind: Experimental
    Label: Control group
    Description: Receive dose-matched conventional neurocognitive therapy

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 Motor impairment of the upper limb Change from Baseline in motor impairment of the upper limb at 4 weeks No
Secondary Functional improvement in dexterity Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks No
Secondary Spasticity level of the upper limb Change from Baseline in spasticity level of the upper limb at 4 weeks No
Secondary Tactile and proprioceptive sensory function of the upper limb Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks No
Secondary Neglect Change from Baseline in neglect at 4 weeks No
Secondary Cognitive impairment Change from Baseline in cognitive impairment at 4 weeks No
Secondary Frontal lobe function Change from Baseline in frontal lobe function at 4 weeks No
Secondary Aphasia Change from Baseline in aphasia at 4 weeks No
Secondary Attention Change from Baseline in attention at 4 weeks No

Sponsors