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

NCT04527783 | Unknown

• 1 other identifier: GREVAP
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in 9-Hole Peg Test

  baseline- immediately after the intervention

• Change in Manual Ability Measurement

  baseline- immediately after the intervention

• Change in the instrumented indexes

  baseline- immediately after the intervention

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Other: control group

Interventions

experimental group OTHER

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

experimental group

control group OTHER

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

control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a single stroke,
• some movement of the fingers,
• any technical and difficulties with wearing the glove on the paretic hand

You may not qualify if:

• visual or cognitive deficits that would prevent them for performing the task

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 27, 2020
• Study Start: September 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 31, 2021
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share