Robotics for Rehabilitation of Hand and Fingers After Stroke

NCT03207490 | Completed

• 1 other identifier: Prot. 2014.14
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

The major issue for a person who has suffered a stroke is the severe impairment affecting the hand and the high risk to have a poor recovery associated. Innovative approaches are needed in the next future, translating recent advances from neuro-engineering, into feasible devices for rehabilitation care. The FP7-EU project MYOSENS aims to translate known motor control logic from sEMG prosthetic control, to rehabilitation robotics. The target is to promote the closing of sensory-motor loop on the basis of intention to move, as detected from residual sEMG (i.e. Extensor Digitorum Communis, Flexor Digitorum Profundus).

Conditions

Stroke

Keywords

Hand; Rehabilitation; sEMG

Outcome Measures

Primary Outcomes (1)

• Change at Box and Block Test (BBT)

  Hand dexterity is measured by means of the BBT. The patient has to carry as much cubes as possible, one by one, from a container to another one in one minute. The test is performed with both hands.

  Before treatment, then 3 weeks after

Secondary Outcomes (5)

• Change at Functional Independence Measure scale (FIM)

  Before treatment, then 3 weeks after

• Change at Reaching Performance Scale (RPS)

  Before treatment, then 3 weeks after

• Change at Modified Ashworth Scale (MAS)

  Before treatment, then 3 weeks after

• Change at Nine Hole Pegboard Test (NHPT)

  Before treatment, then 3 weeks after

• Change at Fugl-Meyer Assessment Scale: Upper Extremity Motor Function (F-M UE)

  Before treatment, then 3 weeks after

Study Arms (1)

Robot group

EXPERIMENTAL

Receive 1 hour of AMADEO (robot-assisted therapy) for the hand and 1 hour of daily standard rehabilitation therapy

Device: AMADEO

Interventions

AMADEO DEVICE

Robot therapy: 1-Degrees-Of-Freedom (1DOFs) robot training for flexion and extention movements of the hand. Standard rehabilitation therapy includes speech, physical, occupational therapies and group activities

Also known as: Robot-assisted therapy for the hand

Robot group

Eligibility Criteria

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

You may qualify if:

• Patients suffering from first stroke, ischemic and/or hemorrhagic
• Score between 1 and 3 at the upper-limb sub-item of the Italian version of the National Institute of Health Stroke Scale, IT-NIHSS (Pezzella et al. 2009)
• Score lower than 100 out of a total of 126 at the Functional Independence Measure (FIM) scale.
• Less than 45 cubes carried in one minute whit the affected hand at the Box and Bocks Test.

You may not qualify if:

• Non-stabilized fractures
• Diagnosis of depression
• Traumatic brain Injury
• Untreated or drug resistant seizures.
• Severe ideomotor apraxia
• Severe neglect
• Patients participating in other rehabilitation treatments for the upper-limb (e.g. virtual reality treatment, motor imagery).

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (2)

Tyromotion GmbH

Graz, 8020, Austria

Location

IRCCS San Camillo Hospital Foundation

Venice, 30126, Italy

Location

Related Publications (4)

• Hwang CH, Seong JW, Son DS. Individual finger synchronized robot-assisted hand rehabilitation in subacute to chronic stroke: a prospective randomized clinical trial of efficacy. Clin Rehabil. 2012 Aug;26(8):696-704. doi: 10.1177/0269215511431473. Epub 2012 Jan 19.

  PMID: 22261813 BACKGROUND

• Sale P, Lombardi V, Franceschini M. Hand robotics rehabilitation: feasibility and preliminary results of a robotic treatment in patients with hemiparesis. Stroke Res Treat. 2012;2012:820931. doi: 10.1155/2012/820931. Epub 2012 Dec 26.

  PMID: 23320252 BACKGROUND

• Stein J, Bishop L, Gillen G, Helbok R. Robot-assisted exercise for hand weakness after stroke: a pilot study. Am J Phys Med Rehabil. 2011 Nov;90(11):887-94. doi: 10.1097/PHM.0b013e3182328623.

  PMID: 21952215 BACKGROUND

• Takahashi CD, Der-Yeghiaian L, Le V, Motiwala RR, Cramer SC. Robot-based hand motor therapy after stroke. Brain. 2008 Feb;131(Pt 2):425-37. doi: 10.1093/brain/awm311. Epub 2007 Dec 20.

  PMID: 18156154 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andrea Turolla, PhD

  IRCCS San Camillo, Venezia, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory Head

Model Details: Intervention is provided by a robotic device for hand motion, controlled by closed loop surface electromyography (sEMG)

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: July 2, 2017
• Study Start: July 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

IT (1); AU (1)