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OpenTrials
Completed

NCT Number: NCT03243123

Upper Limb Robotic Rehabilitation After Stroke

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic passive mobilization

Device

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 8, 2017
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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