Upper Limb Robotic Rehabilitation After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Robotic passive mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Passive mobilization
Arm Description
Upper limb passive mobilization assisted with robotic device
Outcomes
Primary Outcome Measures
Forearm perfusion
Amount of total hemoglobin circulating in the forearm muscle tissues.
Muscle tone
The tone of the muscle assessed with Modified Ashworth Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03243123
First Posted
August 3, 2017
Last Updated
August 7, 2017
Sponsor
Università degli Studi di Brescia
1. Study Identification
Unique Protocol Identification Number
NCT03243123
Brief Title
Upper Limb Robotic Rehabilitation After Stroke
Official Title
Passive Mobilization With Robotic Assistance Improve Hemiparetic Upper Limb Circulation and Functional Status in Stroke Survivors.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
November 15, 2014 (Actual)
Study Completion Date
December 23, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Brescia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Passive mobilization
Arm Type
Experimental
Arm Description
Upper limb passive mobilization assisted with robotic device
Intervention Type
Device
Intervention Name(s)
Robotic passive mobilization
Intervention Description
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 Measure Information:
Title
Forearm perfusion
Description
Amount of total hemoglobin circulating in the forearm muscle tissues.
Time Frame
30 minutes
Title
Muscle tone
Description
The tone of the muscle assessed with Modified Ashworth Scale
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29094043
Citation
Gobbo M, Gaffurini P, Vacchi L, Lazzarini S, Villafane J, Orizio C, Negrini S, Bissolotti L. Hand Passive Mobilization Performed with Robotic Assistance: Acute Effects on Upper Limb Perfusion and Spasticity in Stroke Survivors. Biomed Res Int. 2017;2017:2796815. doi: 10.1155/2017/2796815. Epub 2017 Sep 28.
Results Reference
derived
Learn more about this trial
Upper Limb Robotic Rehabilitation After Stroke
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