Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

NCT ID: NCT02096445

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-06-09

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.

Conditions

Stroke; Upper Extremity Paresis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robot group

Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy.

(4 x 45 min/week)

Group Type: EXPERIMENTAL

robot-assisted neurocognitive therapy of hand function

Intervention Type: DEVICE

2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.

Control group

Receive dose-matched conventional neurocognitive therapy

Group Type: ACTIVE_COMPARATOR

Conventional neurocognitive rehabilitation

Intervention Type: OTHER

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.

Interventions

robot-assisted neurocognitive therapy of hand function

2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Rehabilitation robot ReHapticKnob; Perfetti-concept

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roger Gassert

OTHER

Sponsor Role: lead

Responsible Party

Roger Gassert

Prof. Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Roger Gassert, Prof. Dr.

Role: STUDY_DIRECTOR

Rehabilitation Engineering Lab, ETH Zurich

Locations

Clinica Hildebrand Centro di riabilitazione Brissago

Brissago, Canton Ticino, Switzerland

Countries

Switzerland

References

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.

Reference Type: RESULT

PMID: 24968378 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32831097 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25399249 (View on PubMed)

Related Links

http://www.relab.ethz.ch

Homepage of the investigator's laboratory

Other Identifiers

2013-MD-0002

Identifier Type: OTHER

Identifier Source: secondary_id

CIV-13-02-009921

Identifier Type: -

Identifier Source: org_study_id