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

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Mar 14, 2024

Keywords

ClinConnect Summary

The clinical trial is studying a new device called the SaeboGlove, designed to help adults who have had a stroke regain better use of their weakened arm and hand. After a stroke, many people struggle with their ability to perform everyday tasks due to difficulties in moving their upper limbs. This study aims to see if using this special gripping glove can improve their ability to grasp and hold objects, which is crucial for independence in daily life.

To participate in this trial, individuals must be adults aged between 18 and 85 who have experienced a stroke at least three months ago and have some difficulty opening their hand. Participants should be able to put on the glove with some assistance if needed and have access to a smartphone or computer for remote check-ins. Throughout the trial, participants will use the SaeboGlove in their daily activities, and researchers will monitor their progress. This study is currently recruiting participants, and it's a great opportunity for those looking to improve their upper limb function and regain some independence after a stroke.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Patient presenting retraction or stiffness of the fingers and wrist preventing complete 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 the long and short flexors of the fingers and thumb (Modified Ashworth Scale ≥ 3);
• • Patient with limited active elbow extension, not allowing the ipsilateral knee to be reached with the hand, the subject being seated with the trunk vertical (approach limitation);
• • 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 be reached 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's compliance due to impaired physical and/or psychological health