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

NCT ID: NCT04527783

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-03-31

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.

Conditions

Stroke; Hand Grasp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

experimental group

Intervention Type: OTHER

Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.

control group

Each subject will perform usual care rehabilitation aimed at improving manual dexterity

Group Type: ACTIVE_COMPARATOR

control group

Intervention Type: OTHER

Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.

Interventions

experimental group

Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.

Intervention Type: OTHER

control group

Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Davide Cattaneo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

GREVAP

Identifier Type: -

Identifier Source: org_study_id