The Use of an Engineered Glove for the Assessment and Rehabilitation of Manual Dexterity in People With Stroke.

Study Overview
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Brief Summary
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Stroke often results in impairments of upper extremity, including coordination deficits, reducing of force, weakness and changes in the kinetic and kinematic workspace of fingers with 75% of stroke survivors facing difficulties performing activities of daily living. The ability to oppose the fingertip of the thumb to each fingertip of the same hand is the basis of grasping objects of various sizes and operating tools and assessing and improving distal upper extremity function is of primary goal in the rehabilitation of stroke survivors. Moreover, repetitive movement practice seems to be crucial for maximizing therapeutic benefits. Recent studies, proposed an engineered glove to assess motor performance during finger-to-thumb opposition movements and to provide objective and reproducible measures. The same tool can be integrated with Virtual Reality and serious games to provide repetitive practice of activities improving motivation and adherence with therapy. the investigators developed a new integrated glove and virtual reality to facilitate the recovery of hand functionality. The aim of this study is to investigate the feasibility of the engineered glove in the assessment and treatment of hand dysfunction in people with Stroke.

Official Title
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The Use of an Engineered Glove for the Assessment and Rehabilitation of Manual Dexterity in People With Stroke: a Pilot Randomized Control Trial.

Conditions
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Stroke, Hand Grasp

Intervention / Treatment
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* Other: experimental group
* Other: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a single stroke, some movement of the fingers, any technical and difficulties with wearing the glove on the paretic hand Exclusion Criteria: visual or cognitive deficits that would prevent them for performing the task

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Each subject will perform a variety of VR exercises to reduce impairments in their finger range of motion, speed and strength. It includes a glove-shaped sensor device and a software application. | Other: experimental group<br>* Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.<br>|
| Active Comparator: control group<br>Each subject will perform usual care rehabilitation aimed at improving manual dexterity | Other: control group<br>* Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Box and Blocks Test | Block and Box Test assesses grasp and transport and upper limb functional disorders and measures unilateral gross manual dexterity. | baseline- immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 9-Hole Peg Test | It measures finger dexterity. Patient takes the pegs from a container and place them into the holes as quickly as possible. | baseline- immediately after the intervention | 
| Change in Manual Ability Measurement | It is a self reported questionnaire to rate perceived manual ability on a scale ranging from 0 (impossible to complete any of activity cited) to 100 (every activity cited is accomplished without any difficulty). | baseline- immediately after the intervention | 
| Change in the instrumented indexes | Subjects perform a repetitive finger-to-thumb opposition sequence (index, medium, ring and little finger) with their affected hand at maximal velocity and with the two hands simultaneously at a frequency of 2 Hz paced by a metronome. The testing session includes one 60sec trial per condition. They wear a sensor-engineered glove on both hands to quantitatively assess finger motor performance | baseline- immediately after the intervention |