Upper Limb Robotic Rehabilitation After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243123
• Other study ID #: 201701
• Status: Completed
• Phase: N/A
• First received: August 3, 2017
• Last updated: August 7, 2017
• Start date: June 1, 2014
• Est. completion date: December 23, 2014

Study information

• Verified date: August 2017
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 23, 2014
• Est. primary completion date: November 15, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm perfusion	Amount of total hemoglobin circulating in the forearm muscle tissues.	30 minutes
Primary	Muscle tone	The tone of the muscle assessed with Modified Ashworth Scale	30 minutes