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Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation

NCT02628418 · Fondazione Salvatore Maugeri · Updated 15 Sept 2016

What is being tested
General Rehabilitation; Specific hand rehabilitation by Gloreha device; Specific hand rehabilitation performed by physiotherapist
For
Stroke; Upper Extremity Hemiplegia; Disorder of Hand
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 30 people. The full rules are on the registry page.
Where
Not stated
When
Starts or started May 2013, ends June 2014. Registered 11 Dec 2015.
Results
Posted on the registry on 3 Aug 2016.

In the researchers' words

Hand recovery following cerebral stroke is complex and requires intensive training. The investigators aimed to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation compared to physiotherapist-guided treatment in recovering dexterity and hand strength in hospitalized sub-acute hemiplegic patients. Design. 30 patients affected by stroke from cerebral ischemia or hemorrhage (Ashworth spasticity index \<3) were randomized. Patients in the Treatment group received intensive hand training with Gloreha, a hand rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of the fingers, with multisensory feedback. Patients in the Control group received conventional intensive hand rehabilitation under physiotherapist guidance. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch test) were measured at baseline and after rehabilitation, and the differences between final and basal results were compared between groups.
ClinicalTrials.gov, NCT02628418