Upper Limb Robotic Rehabilitation After Stroke
Passive Mobilization With Robotic Assistance Improve Hemiparetic Upper Limb Circulation and Functional Status in Stroke Survivors.
1 other identifier
interventional
23
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jun 2014
Shorter than P25 for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2014
CompletedFirst Submitted
Initial submission to the registry
August 3, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedAugust 8, 2017
August 1, 2017
6 months
August 3, 2017
August 7, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Forearm perfusion
Amount of total hemoglobin circulating in the forearm muscle tissues.
30 minutes
Muscle tone
The tone of the muscle assessed with Modified Ashworth Scale
30 minutes
Study Arms (1)
Passive mobilization
EXPERIMENTALUpper limb passive mobilization assisted with robotic device
Interventions
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.
Eligibility Criteria
You may qualify if:
- first event of cerebrovascular stroke; unilateral paresis; ability to remain in sitting position
You may not qualify if:
- bilateral impairment; cognitive or behaviorql dysfunctions; finger flexion contracture; degenerative or non degenerative neurological conditions; refusal or inability to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29094043DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- MD
Study Record Dates
First Submitted
August 3, 2017
First Posted
August 8, 2017
Study Start
June 1, 2014
Primary Completion
November 15, 2014
Study Completion
December 23, 2014
Last Updated
August 8, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share