Upper Limb Robotic Rehabilitation After Stroke

Sponsor

Università degli Studi di Brescia (Other)

Overall Status

Completed

CT.gov ID

NCT03243123

Collaborator

(none)

Enrollment

Arm

6.7

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Robotic passive mobilization	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Nov 15, 2014

Actual Study Completion Date :

Dec 23, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Forearm perfusion [30 minutes]
Amount of total hemoglobin circulating in the forearm muscle tissues.
Muscle tone [30 minutes]
The tone of the muscle assessed with Modified Ashworth Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Università degli Studi di Brescia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Massimiliano Gobbo, MD, Università degli Studi di Brescia

ClinicalTrials.gov Identifier:

NCT03243123

Other Study ID Numbers:

201701

First Posted:

Aug 8, 2017

Last Update Posted:

Aug 8, 2017

Last Verified:

Aug 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Aug 8, 2017