Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Upper Extremity Paresis
• Intervention / Treatment: Device: robot-assisted neurocognitive therapy of hand function; Other: Conventional neurocognitive rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Ticino
    • Brissago, Ticino, Switzerland, 6614
      • Clinica Hildebrand Centro di riabilitazione Brissago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot group; Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy. (4 x 45 min/week)	Device: robot-assisted neurocognitive therapy of hand function; 2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.; Other Names: Rehabilitation robot ReHapticKnob
Active Comparator: Control group; Receive dose-matched conventional neurocognitive therapy	Other: Conventional neurocognitive rehabilitation; 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.; Other Names: Perfetti-concept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor impairment of the upper limb	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)	Change from Baseline in motor impairment of the upper limb at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor impairment of the upper limb	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)	Change from Baseline in motor impairment of the upper limb at 8 weeks
Motor impairment of the upper limb	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)	Change from Baseline in motor impairment of the upper limb at 6 months
Functional improvement in dexterity	Functional improvement in dexterity is assessed with the Box and Block Test	Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
Functional improvement in dexterity	Functional improvement in dexterity is assessed with the Box and Block Test	Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
Functional improvement in dexterity	Functional improvement in dexterity is assessed with the Box and Block Test	Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
Spasticity level of the upper limb	Spasticity level is measured with the Modified Ashworth Scale	Change from Baseline in spasticity level of the upper limb at 4 weeks
Spasticity level of the upper limb	Spasticity level is measured with the Modified Ashworth Scale	Change from Baseline in spasticity level of the upper limb at 8 weeks
Spasticity level of the upper limb	Spasticity level is measured with the Modified Ashworth Scale	Change from Baseline in spasticity level of the upper limb at 6 months
Tactile and proprioceptive sensory function of the upper limb	Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment	Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
Tactile and proprioceptive sensory function of the upper limb	Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment	Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
Tactile and proprioceptive sensory function of the upper limb	Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment	Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
Neglect	Neglect is assessed with the Albert's test of neglect	Change from Baseline in neglect at 4 weeks
Neglect	Neglect is assessed with the Albert's test of neglect	Change from Baseline in neglect at 8 weeks
Neglect	Neglect is assessed with the Albert's test of neglect	Change from Baseline in neglect at 6 months
Cognitive impairment	Cognitive impairment is assessed with the Mini Mental State Examination	Change from Baseline in cognitive impairment at 4 weeks
Cognitive impairment	Cognitive impairment is assessed with the Mini Mental State Examination	Change from Baseline in cognitive impairment at 8 weeks
Cognitive impairment	Cognitive impairment is assessed with the Mini Mental State Examination	Change from Baseline in cognitive impairment at 6 months
Frontal lobe function	Frontal lobe function is assessed with the Frontal assessment battery	Change from Baseline in frontal lobe function at 4 weeks
Frontal lobe function	Frontal lobe function is assessed with the Frontal assessment battery	Change from Baseline in frontal lobe function at 8 weeks
Frontal lobe function	Frontal lobe function is assessed with the Frontal assessment battery	Change from Baseline in frontal lobe function at 6 months
Aphasia	Aphasia is assessed with the Aachener Aphasia Test	Change from Baseline in aphasia at 4 weeks
Aphasia	Aphasia is assessed with the Aachener Aphasia Test	Change from Baseline in aphasia at 8 weeks
Aphasia	Aphasia is assessed with the Aachener Aphasia Test	Change from Baseline in aphasia at 6 months
Attention	Attention is assessed with the test to identify attention	Change from Baseline in attention at 4 weeks
Attention	Attention is assessed with the test to identify attention	Change from Baseline in attention at 8 weeks
Attention	Attention is assessed with the test to identify attention	Change from Baseline in attention at 6 months

Collaborators and Investigators

• Sponsor: Roger Gassert
• Investigators: Study Director: Roger Gassert, Prof. Dr., Rehabilitation Engineering Lab, ETH Zurich

Publications and helpful links

General Publications

• Metzger JC, Lambercy O, Califfi A, Conti FM, Gassert R. Neurocognitive robot-assisted therapy of hand function. IEEE Trans Haptics. 2014 Apr-Jun;7(2):140-9. doi: 10.1109/TOH.2013.72.
• Ranzani R, Lambercy O, Metzger JC, Califfi A, Regazzi S, Dinacci D, Petrillo C, Rossi P, Conti FM, Gassert R. Neurocognitive robot-assisted rehabilitation of hand function: a randomized control trial on motor recovery in subacute stroke. J Neuroeng Rehabil. 2020 Aug 24;17(1):115. doi: 10.1186/s12984-020-00746-7.
• Metzger JC, Lambercy O, Califfi A, Dinacci D, Petrillo C, Rossi P, Conti FM, Gassert R. Assessment-driven selection and adaptation of exercise difficulty in robot-assisted therapy: a pilot study with a hand rehabilitation robot. J Neuroeng Rehabil. 2014 Nov 15;11:154. doi: 10.1186/1743-0003-11-154.

Helpful Links

• Homepage of the investigator's laboratory

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): March 10, 2017
• Study Completion (Actual): June 9, 2017

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 9, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: acute; stroke; rehabilitation; neurocognitive; sensory; hand function; fine motor skills; robot therapy; Perfetti; haptics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: CIV-13-02-009921; 2013-MD-0002 (Other Identifier: Swissmedic)