Clinical trial NCT06312631: Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults
Official title: Benefits of a Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults: Comparative Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: brain-injured adult
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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 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

Primary outcomes:
measure: Evaluation of the effectiveness of the gripping glove
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of the performance of an activity in the real context of the patient
timeFrame: 6 months
measure: Evaluation of factual spontaneous use of the upper limb in daily life
timeFrame: 6 months
measure: Evaluation of the perceived performance of the use of the paretic upper limb
timeFrame: 6 months
measure: Assessment of the quality of voluntary motor skills of the upper limb
timeFrame: 6 months
measure: Assessment of gripping abilities
timeFrame: 6 months
measure: Quality of life assessment
timeFrame: 6 months
measure: Evaluation of satisfaction and tolerance
timeFrame: 6 months
measure: Evaluation of the psycho-social impact
timeFrame: 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Claire VILLEPINTE
Study officials:
affiliation: University Hospital, Toulouse
name: Claire VILLEPINTE
role: PRINCIPAL_INVESTIGATOR
References: