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

Stroke Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04527783
• Other study ID #: GREVAP
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2020
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand Grasp
• Stroke

Intervention

Other:
• experimental group
Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.
• control group
Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline- immediately after the intervention
Secondary	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).	baseline- immediately after the intervention
Secondary	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	baseline- immediately after the intervention