Using a special glove to help stroke patients improve upper limb function

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

This study is testing a special glove to see if it can help stroke patients improve the use of their affected arm and hand in everyday activities.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: University Hospital, Toulouse (other)
• Locations: 1 site (Toulouse)
• Trial ID: NCT06312631 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the SaeboGlove, a gripping glove designed to assist brain-injured adults with upper limb motor deficits resulting from stroke. The intervention aims to enhance the use and function of the affected limb in daily activities, promoting independence and social participation. Participants will engage in assessments such as the ULPA questionnaire, Motor Activity Log, and Fugl-Meyer Assessment to measure improvements in motor function and compliance. The study focuses on individuals who have experienced a stroke more than three months prior and are unable to grasp objects independently.

Who should consider this trial

Good fit: Ideal candidates are adults who have suffered a stroke more than three months ago and have difficulty using their affected upper limb.

Not a fit: Patients who have not experienced a stroke or those with severe cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the daily functioning and independence of stroke survivors.

How similar studies have performed: Previous studies have shown promise in using assistive devices for stroke rehabilitation, indicating potential for success with this approach.

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

Where this trial is running

Toulouse

• Claire VILLEPINTE — Toulouse, France (RECRUITING)

Study contacts

• Principal investigator: Claire VILLEPINTE — University Hospital, Toulouse
• Study coordinator: Claire VILLEPINTE

Conditions: Stroke, brain-injured adult