Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults

Last updated: September 24, 2024
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

ULPA questionnaire

EuroQol five-level (EQ-5D-5L) questionnaire

Motor Activity Log (MAL) Questionnaire

Clinical Study ID

NCT06312631
RC31/21/0342
  • Ages 18-90
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patient suffering from a motor deficit of the upper limb resulting from an ischemicor 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 graspan 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 passivelyin the hand;

  • Patient capable of passively opening the hand sufficient to grasp the glass when thegripping 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 withthe help of a third person if necessary and/or available.

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

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

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

Exclusion

Exclusion Criteria:

  • Patient presenting retraction or stiffness of the fingers and wrist preventingcomplete extension of the long fingers and thumb, the wrist being at 15° extension;

  • Patient with moderate or severe muscular spasticity of the wrist flexors and thelong and short flexors of the fingers and thumb (Modified Ashworth Scale ≥ 3);

  • Patient with limited active elbow extension, not allowing the ipsilateral knee to bereached with the hand, the subject being seated with the trunk vertical (approachlimitation);

  • Patient with an active anterior shoulder elevation range of less than 15°;

  • Patient with other upper limb deficiencies likely to influence participation;

  • Patient and/or entourage who do not have access to teleconsultation, and/or can bereached remotely;

  • Patient with severe aphasia, Boston Diagnostic Aphasia Examination (BDAE) ≤ 3;

  • Presence of moderate or severe edema localized to the wrist and hand;

  • Patient allergic to Latex

  • History of upper limb surgery less than 6 months old.

  • Pregnant and/or breastfeeding women

  • Patient deprived of liberty (detained/incarcerated);

  • Patient under judicial protection

  • Impossibility of giving the person informed information and ensuring the subject'scompliance due to impaired physical and/or psychological health

Study Design

Total Participants: 100
Treatment Group(s): 10
Primary Treatment: ULPA questionnaire
Phase:
Study Start date:
March 26, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Claire VILLEPINTE

    Toulouse,
    France

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.