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

About this trial
This is an interventional treatment trial for Stroke
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
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
NCT ID
NCT04527783
First Posted
August 19, 2020
Last Updated
August 25, 2020
Sponsor
Fondazione Don Carlo Gnocchi Onlus
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.
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