Upper Limb Robotic Rehabilitation After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03243123
Recruitment Status : Completed
First Posted : August 8, 2017
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):
Massimiliano Gobbo, Università degli Studi di Brescia

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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 : June 1, 2014
Actual Primary Completion Date : November 15, 2014
Actual Study Completion Date : December 23, 2014

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.

Primary Outcome Measures :
  1. Forearm perfusion [ Time Frame: 30 minutes ]
    Amount of total hemoglobin circulating in the forearm muscle tissues.

  2. Muscle tone [ Time Frame: 30 minutes ]
    The tone of the muscle assessed with Modified Ashworth Scale

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Massimiliano Gobbo, MD, Università degli Studi di Brescia Identifier: NCT03243123     History of Changes
Other Study ID Numbers: 201701
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases