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

Not Applicable

• Conditions: Stroke; Hand Grasp
• Interventions: Other: experimental group; Other: control group

• Registration Number: NCT04527783
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-25
• Last Update Submitted: 2020-08-25
• Study First Posted: 2020-08-27
• Last Update Posted: 2020-08-27
• Study Start: 2020-09-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	experimental group	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.
control group	control group	Each subject will perform usual care rehabilitation aimed at improving manual dexterity

Primary Outcome Measures

Name	Time	Method
Change in Box and Blocks Test	baseline- immediately after the intervention	Block and Box Test assesses grasp and transport and upper limb functional disorders and measures unilateral gross manual dexterity.

Secondary Outcome Measures

Name	Time	Method
Change in the instrumented indexes	baseline- immediately after the intervention	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
Change in 9-Hole Peg Test	baseline- immediately after the intervention	It measures finger dexterity. Patient takes the pegs from a container and place them into the holes as quickly as possible.
Change in Manual Ability Measurement	baseline- immediately after the intervention	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).