Benefits of a Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults: Comparative Multicenter Study

Status: Recruiting

Location: See location...

Intervention Type: Other, Device

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

On a functional level, performing the actions of daily life requires coordinated activity of the muscles of the upper limbs. The quality of motor recovery and/or technical assistance aimed at compensating for the movement deficit of the paretic upper limb (MSP) determines the possibilities of using the upper limb (MS) in activities of daily life. Interventions in the chronic phase of stroke aim to return home. The integration of the paretic upper limb into daily life activities is a major issue regarding the prognosis of recovery of use of the upper limb. Independence in daily life becomes an ultimate goal to take charge of. This study focuses on a new technical aid device, standard orthosis type, expanding the range of gripping gloves: the SaeboGlove in everyday environments. These MS orthoses help improve the use and function of the MSP in post-stroke adults as well as their independence and participation in society.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 90

Healthy Volunteers: f

View:

• Patient suffering from a motor deficit of the upper limb resulting from an ischemic or hemorrhagic stroke, hemispheric or brainstem, confirmed by brain imaging ;

• Patient who suffered a stroke more than three months ago;

• Patient unable to actively extend long fingers (hand opening) to voluntarily grasp an empty glass (upper and lower diameter of 7 and 6 cm respectively, height of 12 to 15 cm, weight of 125g, identical to equipment used for ARAT), with a palmar grip (cylindrical grip), while the subject can hold the previously placed glass passively in the hand;

• Patient capable of passively opening the hand sufficient to grasp the glass when the gripping glove is put on, with the possibility of actively closing the hand;

• Patient with the ability to put on and remove the SaeboGlove® gripping glove with the help of a third person if necessary and/or available.

• Patient with a smartphone, tablet and/or computer compatible with video taking and teleconsultation.

• Free, informed and signed consent by the participant and/or the person having guardianship and the investigator (at the latest on the day of inclusion and before any examination required by the research);

• Person affiliated to or beneficiary of a social security system.

Locations

Other Locations

France

Claire VILLEPINTE

RECRUITING

Toulouse

Contact Information

Primary

Claire VILLEPINTE

villepinte.c@chu-toulouse.fr

0567771724

Backup

Audrey TOMASIK

tomasik.a@chu-toulouse.fr

0561778597

Time Frame

Start Date: 2024-03-26

Estimated Completion Date: 2026-12-31

Participants

Target number of participants: 100

Treatments

Experimental: Task handover model #1

At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B).~The order of administration with then without the glove (AB) or without then with the glove (BA) is drawn at random for each patient.~The 1st model follows the following diagram:~Visit T1 = AB; Visit T2 = AB; Visit T3 = AB

Experimental: Task handover model #2

At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B).~The order of administration with then without the glove (AB) or without then with the glove (BA) is drawn at random for each patient.~The 2nd model follows the following diagram:~Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB

Experimental: Task handover model #3

At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B).~The order of administration with then without the glove (AB) or without then with the glove (BA) is drawn at random for each patient.~The 3rd model follows the following diagram:~Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB

Experimental: Task handover model #4

At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B).~The order of administration with then without the glove (AB) or without then with the glove (BA) is drawn at random for each patient.~The 4th model follows the following diagram:~Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA

Experimental: Task handover model #5

At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B).~The order of administration with then without the glove (AB) or without then with the glove (BA) is drawn at random for each patient.~The 5th model follows the following diagram:~Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB

Experimental: Task handover model #6

At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B).~The order of administration with then without the glove (AB) or without then with the glove (BA) is drawn at random for each patient.~The 6th model follows the following diagram:~Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA

Experimental: Task handover model #7

At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B).~The order of administration with then without the glove (AB) or without then with the glove (BA) is drawn at random for each patient.~The 7th model follows the following diagram:~Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA

Experimental: Task handover model #8

At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B).~The order of administration with then without the glove (AB) or without then with the glove (BA) is drawn at random for each patient.~The 8th model follows the following diagram:~Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA

Related Therapeutic Areas

HIV/AIDS

Stroke

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Benefits of a Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults: Comparative Multicenter Study

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