Upper Limb Robotic Rehabilitation After Stroke

August 7, 2017 updated by: Massimiliano Gobbo, Università degli Studi di Brescia

Passive Mobilization With Robotic Assistance Improve Hemiparetic Upper Limb Circulation and Functional Status in Stroke Survivors.

This is a single arm study aimed at evaluating the acute effects induced by a single session of robot-assisted passive hand mobilization on local perfusion and upper limb function in post-stroke hemiparetic patients. Twenty-three participants with subacute or chronic stroke received 20 min passive mobilization of the paretic hand with robotic assistance. After the intervention, significant improvements were found in forearm perfusion, muscle tone significantly decreased and subjects reported decreased upper limb heaviness, stiffness and pain. This study supports novel evidence that hand robotic assistance promotes local forearm circulation, may help in the management of spasticity and acutely alleviates reported symptoms of heaviness, stiffness and pain in subjects with post-stroke hemiparesis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • first event of cerebrovascular stroke; unilateral paresis; ability to remain in sitting position

Exclusion Criteria:

  • bilateral impairment; cognitive or behaviorql dysfunctions; finger flexion contracture; degenerative or non degenerative neurological conditions; refusal or inability to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Passive mobilization
Upper limb passive mobilization assisted with robotic device
Device: Robotic passive mobilization
The intervention was performed using the Gloreha (Idrogenet, Italy) robotic system. The system consists of a soft exoskeleton similar to a glove. Passive hand joints mobilization is provided by a hydraulic system. Each patient underwent a session of 20 min passive mobilization of the paretic hand.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forearm perfusion
Time Frame: 30 minutes
Amount of total hemoglobin circulating in the forearm muscle tissues.
30 minutes
Muscle tone
Time Frame: 30 minutes
The tone of the muscle assessed with Modified Ashworth Scale
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

November 15, 2014

Study Completion (Actual)

December 23, 2014

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

August 7, 2017

First Posted (Actual)

August 8, 2017

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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