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

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Hand Grasp
• Intervention / Treatment: Other: experimental group; Other: control group

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: experimental group; Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.
Active Comparator: control group; Each subject will perform usual care rehabilitation aimed at improving manual dexterity	Other: control group; Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): February 28, 2021
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: GREVAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No