search
Back to results

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

Primary Purpose

Stroke, Hand Grasp

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
experimental group
control group
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    experimental group

    control group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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).
    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

    Full Information

    First Posted
    August 19, 2020
    Last Updated
    August 25, 2020
    Sponsor
    Fondazione Don Carlo Gnocchi Onlus
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04527783
    Brief Title
    The Use of an Engineered Glove for the Assessment and Rehabilitation of Manual Dexterity in People With Stroke.
    Official Title
    The Use of an Engineered Glove for the Assessment and Rehabilitation of Manual Dexterity in People With Stroke: a Pilot Randomized Control Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    February 28, 2021 (Anticipated)
    Study Completion Date
    March 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fondazione Don Carlo Gnocchi Onlus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Hand Grasp

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    Each subject will perform usual care rehabilitation aimed at improving manual dexterity
    Intervention Type
    Other
    Intervention Name(s)
    experimental group
    Intervention Description
    Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.
    Intervention Type
    Other
    Intervention Name(s)
    control group
    Intervention Description
    Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.
    Primary Outcome Measure Information:
    Title
    Change in Box and Blocks Test
    Description
    Block and Box Test assesses grasp and transport and upper limb functional disorders and measures unilateral gross manual dexterity.
    Time Frame
    baseline- immediately after the intervention
    Secondary Outcome Measure Information:
    Title
    Change in 9-Hole Peg Test
    Description
    It measures finger dexterity. Patient takes the pegs from a container and place them into the holes as quickly as possible.
    Time Frame
    baseline- immediately after the intervention
    Title
    Change in Manual Ability Measurement
    Description
    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).
    Time Frame
    baseline- immediately after the intervention
    Title
    Change in the instrumented indexes
    Description
    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
    Time Frame
    baseline- immediately after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs