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NCT06312631Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 1 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
8 Mar 2024
Start date
26 Mar 2024
Primary completion date
31 Dec 2027
Lead sponsor
University Hospital, Toulouse
Diseases
Stroke
NCT number
NCT06312631

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 26 Mar 2024 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patient allergic to Latex
  • History of upper limb surgery less than 6 months old.

Other

  • 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;
  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Claire VILLEPINTE
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.