Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

Roger Gassert

Status: Completed

Conditions: Upper Extremity Paresis; Stroke

Treatments: Device: robot-assisted neurocognitive therapy of hand function; Other: Conventional neurocognitive rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02096445

2013-MD-0002 (Other Identifier)

CIV-13-02-009921

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 18-90 years old
• hemisyndrome (central paralysis of the upper extremity, and all degrees of weakness: M0 - M5 on the paresis scale) as a result of a first stroke
• sub-acute lesion not more than 6 weeks post ictus

Exclusion criteria

• insufficient state of consciousness
• severe aphasia
• severe cognitive deficits
• severe pathologies of the upper extremity of traumatic or rheumatic nature
• severe pain in the affected arm
• Patients with pacemakers and other active implants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

34 participants in 2 patient groups

Robot group

Experimental group

Description:

Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy. (4 x 45 min/week)

Treatment:

Device: robot-assisted neurocognitive therapy of hand function

Control group

Active Comparator group

Description:

Receive dose-matched conventional neurocognitive therapy

Treatment:

Other: Conventional neurocognitive rehabilitation