Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

NCT02096445 | Completed DMC

• 2 other identifiers: CIV-13-02-0099212013-MD-0002
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; acute; rehabilitation; robot therapy; hand function; fine motor skills; neurocognitive; sensory; Perfetti; haptics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• Motor impairment of the upper limb

  Change from Baseline in motor impairment of the upper limb at 8 weeks

• Motor impairment of the upper limb

  Change from Baseline in motor impairment of the upper limb at 6 months

• Functional improvement in dexterity

  Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks

• Functional improvement in dexterity

  Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks

• Functional improvement in dexterity

  Change from Baseline in functional improvement of dexterity of the upper limb at 6 months

Study Arms (2)

Robot group

EXPERIMENTAL

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

Device: robot-assisted neurocognitive therapy of hand function

Control group

ACTIVE COMPARATOR

Receive dose-matched conventional neurocognitive therapy

Other: Conventional neurocognitive rehabilitation

Interventions

robot-assisted neurocognitive therapy of hand function DEVICE

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

Also known as: Rehabilitation robot ReHapticKnob

Robot group

Conventional neurocognitive rehabilitation 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.

Also known as: Perfetti-concept

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roger Gassert: lead

Study Sites (1)

Clinica Hildebrand Centro di riabilitazione Brissago

Brissago, Canton Ticino, 6614, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 24968378 RESULT

• 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.

  PMID: 32831097 DERIVED

• 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.

  PMID: 25399249 DERIVED

Related Links

• Homepage of the investigator's laboratory

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roger Gassert, Prof. Dr.

  Rehabilitation Engineering Lab, ETH Zurich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 26, 2014
• Study Start: April 1, 2013
• Primary Completion: March 10, 2017
• Study Completion: June 9, 2017
• Last Updated: June 12, 2017

Record last verified: 2017-06

Locations

CH (1)