Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

Not Applicable

Completed

• Conditions: Upper Extremity Paresis; Stroke
• Interventions: Device: robot-assisted neurocognitive therapy of hand function; Other: Conventional neurocognitive rehabilitation

• Registration Number: NCT02096445
• Lead Sponsor: Roger Gassert

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Primary Completion: 2017-03-10
• Status Verified: 2017-06
• Study Completion: 2017-06-09
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot group	robot-assisted neurocognitive therapy of hand function	Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy. (4 x 45 min/week)
Control group	Conventional neurocognitive rehabilitation	Receive dose-matched conventional neurocognitive therapy

Primary Outcome Measures

Name	Time	Method
Motor impairment of the upper limb	Change from Baseline in motor impairment of the upper limb at 4 weeks	Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)

Secondary Outcome Measures

Name	Time	Method
Spasticity level of the upper limb	Change from Baseline in spasticity level of the upper limb at 6 months	Spasticity level is measured with the Modified Ashworth Scale
Neglect	Change from Baseline in neglect at 6 months	Neglect is assessed with the Albert's test of neglect
Cognitive impairment	Change from Baseline in cognitive impairment at 6 months	Cognitive impairment is assessed with the Mini Mental State Examination
Functional improvement in dexterity	Change from Baseline in functional improvement of dexterity of the upper limb at 6 months	Functional improvement in dexterity is assessed with the Box and Block Test
Motor impairment of the upper limb	Change from Baseline in motor impairment of the upper limb at 6 months	Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
Frontal lobe function	Change from Baseline in frontal lobe function at 6 months	Frontal lobe function is assessed with the Frontal assessment battery
Tactile and proprioceptive sensory function of the upper limb	Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months	Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Aphasia	Change from Baseline in aphasia at 6 months	Aphasia is assessed with the Aachener Aphasia Test
Attention	Change from Baseline in attention at 6 months	Attention is assessed with the test to identify attention

Trial Locations

Locations (1)

Clinica Hildebrand Centro di riabilitazione Brissago; 🇨🇭 Brissago, Ticino, Switzerland