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Clinical Trials/NCT04527783
NCT04527783UnknownNot Applicable

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

Fondazione Don Carlo Gnocchi Onlus0 sites30 target enrollmentStarted: September 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Primary Endpoint
Change in Box and Blocks Test

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in Box and Blocks Test

Time Frame: baseline- immediately after the intervention

Block and Box Test assesses grasp and transport and upper limb functional disorders and measures unilateral gross manual dexterity.

Secondary Outcomes

  • Change in the instrumented indexes(baseline- immediately after the intervention)
  • Change in 9-Hole Peg Test(baseline- immediately after the intervention)
  • Change in Manual Ability Measurement(baseline- immediately after the intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Davide Cattaneo

Principal Investigator

Fondazione Don Carlo Gnocchi Onlus

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