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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Claire VILLEPINTE
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Claire VILLEPINTE — University Hospital, Toulouse
• Study coordinator: Claire VILLEPINTE
• Email: villepinte.c@chu-toulouse.fr
• Phone: 0567771724

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

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• Dual-task balance training plus computer-based cognitive training after stroke

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.