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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04527783
Enrollment
30
Registered
2020-08-27
Start date
2020-09-01
Completion date
2021-03-31
Last updated
2020-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Grasp, Stroke

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.

Interventions

OTHERexperimental group

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

OTHERcontrol group

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

Sponsors

Fondazione Don Carlo Gnocchi Onlus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Box and Blocks Testbaseline- immediately after the interventionBlock and Box Test assesses grasp and transport and upper limb functional disorders and measures unilateral gross manual dexterity.

Secondary

MeasureTime frameDescription
Change in 9-Hole Peg Testbaseline- immediately after the interventionIt measures finger dexterity. Patient takes the pegs from a container and place them into the holes as quickly as possible.
Change in Manual Ability Measurementbaseline- immediately after the interventionIt 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 indexesbaseline- immediately after the interventionSubjects 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026