StrokeECO-HAND-AVCNCT06312631

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

A study testing Putting on the gripping glove, ULPA questionnaire and Motor Activity Log (MAL) Questionnaire in people with Stroke, run by University Hospital, Toulouse at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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)… Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Stroke
What is being tested?: Putting on the gripping glove, ULPA questionnaire and Motor Activity Log (MAL) Questionnaire
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteFrance
Study dates: 26 Mar 2024to 31 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Claire VILLEPINTE contact

0567771724 ext. +33

villepinte.c@chu-toulouse.fr

Audrey TOMASIK contact

0561778597 ext. +33

tomasik.a@chu-toulouse.fr

France1 site, 1 recruiting

Claire VILLEPINTE
Toulouse
Claire VILLEPINTE, 0567771724 ext. +33, villepinte.c@chu-toulouse.fr
Audrey TOMASIK, 0561778597 ext. +33, tomasik.a@chu-toulouse.fr
Recruiting

Other trials in France

About this study

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

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.

Conditions: Stroke
Being tested: Putting on the gripping glove, ULPA questionnaire, Motor Activity Log (MAL) Questionnaire, Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire, Score Action Arm Research Test
Keywords: brain-injured adult
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Putting on the gripping gloveDevice
taking measurements and putting the gripping glove on the patient
ULPA questionnaireOther
The evaluation of the effectiveness of the gripping glove on the performance of the upper limb in daily life will be evaluated using the ULPA score.
The investigator asks the patient to perform a task and the ULPA collects the total number of errors made by the patient (inability/omission, imprecision, repetition, time to complete the task)
Motor Activity Log (MAL) QuestionnaireOther
The MAL is a self-assessment of the integration of the upper limb into daily life. This measurement allows a quantified evaluation of the perceived performance of the use of the upper limb in the actions of daily life.
The patient will answer 30 questions about daily life and for each item, rate the quantity from 0 to 5: 0 = never uses the hemiplegic arm and 5 = uses as much as before the accident
Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaireOther
This questionnaire assesses the motor selectivity of the upper limb. Several questions are asked about the movements that the patient can perform and to each question, the patient can answer either 0 (minimum) and 2 (maximum).
Score Action Arm Research TestOther
This questionnaire evaluates 4 different actions: Grasping an object (6 different objects to grasp), holding an object (4 different objects), pinching an object (6 different objects) and the overall movements made by the patient (3 different overall movements).
For each item, each object or each movement evaluated, the patient must rate the task on a scale of 0 to 3 (0=cannot perform any part of the test and 3=performs the test normally)
EuroQol five-level (EQ-5D-5L) questionnaireOther
This questionnaire assesses the patient's state of health. 5 items are proposed (mobility, autonomy, current activity, pain, anxiety) and for each the patient must check one of the 5 propositions (no problem, mild problems, moderate problems, severe problems, incapable). The patient must also rate their state of health on a scale of 0 to 100.
Quebec User Evaluation of Satisfaction with Assistive TechnologyOther
This questionnaire assesses satisfaction with the technical aid (here the gripping glove) and the related services. The technique and related services will be evaluated by items provided to the patient and he will have to rate for each of them a score between 1 and 5 (1 = not satisfied at all and 5 = very satisfied)
Psychosocial Impact of Assistive Devices Scale (PIADS)Other
This questionnaire measures the effect of technical aids on the psychosocial level. 26 sentences or words are offered to the patient concerning his psychological state and the patient must evaluate them between -3 and 3 (-3 = decreased and +3: increased)
Goal Attainment Scale (GAS)Other
Carrying out an activity in the patient's real context is assessed using the Goal Attainment Scale (GAS). The doctor gives the patient objectives to achieve and the patient must give the quotation for each objective between initial state (-2), expected result (0) and best possible result (2)
installation and collection of accelerometersOther
The accelerometer quantitatively reports the spontaneous use of the upper limb in daily life. It counts the number of voluntary movements of the upper limbs. The amount of movement of the paretic upper limb will be expressed as a percentage of the movements of the non-paretic limb.

Study groups in NCT06312631
Study group	Role	What they receive
Task handover model #1	Experimental	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 1st model follows the following diagram: Visit T1 = AB; Visit T2 = AB; Visit T3 = AB Receives: Device: Putting on the gripping glove; Other: ULPA questionnaire; Other: Motor Activity Log (MAL) Questionnaire; Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire; Other: Score Action Arm Research Test; Other: EuroQol five-level (EQ-5D-5L) questionnaire; Other: Quebec User Evaluation of Satisfaction with Assistive Technology; Other: Psychosocial Impact of Assistive Devices Scale (PIADS); Other: Goal Attainment Scale (GAS); Other: installation and collection of accelerometers
Task handover model #2	Experimental	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 2nd model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB Receives: Device: Putting on the gripping glove; Other: ULPA questionnaire; Other: Motor Activity Log (MAL) Questionnaire; Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire; Other: Score Action Arm Research Test; Other: EuroQol five-level (EQ-5D-5L) questionnaire; Other: Quebec User Evaluation of Satisfaction with Assistive Technology; Other: Psychosocial Impact of Assistive Devices Scale (PIADS); Other: Goal Attainment Scale (GAS); Other: installation and collection of accelerometers
Task handover model #3	Experimental	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 3rd model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB Receives: Device: Putting on the gripping glove; Other: ULPA questionnaire; Other: Motor Activity Log (MAL) Questionnaire; Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire; Other: Score Action Arm Research Test; Other: EuroQol five-level (EQ-5D-5L) questionnaire; Other: Quebec User Evaluation of Satisfaction with Assistive Technology; Other: Psychosocial Impact of Assistive Devices Scale (PIADS); Other: Goal Attainment Scale (GAS); Other: installation and collection of accelerometers
Task handover model #4	Experimental	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 4th model follows the following diagram: Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA Receives: Device: Putting on the gripping glove; Other: ULPA questionnaire; Other: Motor Activity Log (MAL) Questionnaire; Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire; Other: Score Action Arm Research Test; Other: EuroQol five-level (EQ-5D-5L) questionnaire; Other: Quebec User Evaluation of Satisfaction with Assistive Technology; Other: Psychosocial Impact of Assistive Devices Scale (PIADS); Other: Goal Attainment Scale (GAS); Other: installation and collection of accelerometers
Task handover model #5	Experimental	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 5th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB Receives: Device: Putting on the gripping glove; Other: ULPA questionnaire; Other: Motor Activity Log (MAL) Questionnaire; Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire; Other: Score Action Arm Research Test; Other: EuroQol five-level (EQ-5D-5L) questionnaire; Other: Quebec User Evaluation of Satisfaction with Assistive Technology; Other: Psychosocial Impact of Assistive Devices Scale (PIADS); Other: Goal Attainment Scale (GAS); Other: installation and collection of accelerometers
Task handover model #6	Experimental	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 6th model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA Receives: Device: Putting on the gripping glove; Other: ULPA questionnaire; Other: Motor Activity Log (MAL) Questionnaire; Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire; Other: Score Action Arm Research Test; Other: EuroQol five-level (EQ-5D-5L) questionnaire; Other: Quebec User Evaluation of Satisfaction with Assistive Technology; Other: Psychosocial Impact of Assistive Devices Scale (PIADS); Other: Goal Attainment Scale (GAS); Other: installation and collection of accelerometers
Task handover model #7	Experimental	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 7th model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA Receives: Device: Putting on the gripping glove; Other: ULPA questionnaire; Other: Motor Activity Log (MAL) Questionnaire; Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire; Other: Score Action Arm Research Test; Other: EuroQol five-level (EQ-5D-5L) questionnaire; Other: Quebec User Evaluation of Satisfaction with Assistive Technology; Other: Psychosocial Impact of Assistive Devices Scale (PIADS); Other: Goal Attainment Scale (GAS); Other: installation and collection of accelerometers
Task handover model #8	Experimental	At each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 8th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA Receives: Device: Putting on the gripping glove; Other: ULPA questionnaire; Other: Motor Activity Log (MAL) Questionnaire; Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire; Other: Score Action Arm Research Test; Other: EuroQol five-level (EQ-5D-5L) questionnaire; Other: Quebec User Evaluation of Satisfaction with Assistive Technology; Other: Psychosocial Impact of Assistive Devices Scale (PIADS); Other: Goal Attainment Scale (GAS); Other: installation and collection of accelerometers

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of the effectiveness of the gripping glove
The evaluation of the effectiveness of the gripping glove on the performance of the upper limb in daily life will be evaluated using the ULPA score and compared between the 2 conditions (with and without the glove) in the performance of a daily activity.
Measured: 6 months

Secondary outcomes (8)

Evaluation of the performance of an activity in the real context of the patient
The performance of an activity in the real context of the patient will be evaluated using the GAS. Information is collected from the person and/or their entourage at each visit, assessed during visits T1 (14 days), T2 (3 months) and T3 (6 months) by the assessor (occupational therapist) from each center.
Measured: 6 months
Evaluation of factual spontaneous use of the upper limb in daily life
Factual spontaneous use of the upper limb in daily life will be measured using a wrist accelerometer. The movement will be compared between T0, T2 (3 months) and T3 (6 months).
Measured: 6 months
Evaluation of the perceived performance of the use of the paretic upper limb
The perceived performance of the use of the paretic upper limb will be evaluated using the MAL at T0, T2 (3 months) and T3 (6 months).
Measured: 6 months
Assessment of the quality of voluntary motor skills of the upper limb
The quality of voluntary motor skills of the upper limb will be assessed with the FMA at T0, T2 (3 months) and T3 (6 months), without wearing the gripping glove.
Measured: 6 months
Assessment of gripping abilities
Grasping abilities will be assessed by the ARAT at T0, T2 (3 months) and T3 (6 months), without wearing the gripping glove.
Measured: 6 months
Quality of life assessment
Quality of life, assessed using the EQ-5D-5L, will be explored at T0, T2 (3 months) and T3 (6 months).
Measured: 6 months
Evaluation of satisfaction and tolerance
Satisfaction and tolerance will be assessed by the patient with the QUEST version 2.0 questionnaire, at the end of the T3 visit (6 months).
Measured: 6 months
Evaluation of the psycho-social impact
The psycho-social impact will be assessed with the F-PIADS questionnaire during visits to T2 (3 months) T3 (6 months), by the evaluator (occupational therapist) from each center.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 202431 Dec 2027

First posted15 Mar 2024
Study start26 Mar 2024
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06312631
Sponsor's protocol ID: RC31/21/0342
Acronym: ECO-HAND-AVC
Status last verified: May 2026
First submitted: 8 Mar 2024
Last updated: 1 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Claire VILLEPINTE

0567771724 ext. +33

villepinte.c@chu-toulouse.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06312631
Acronym / sponsor ID: ECO-HAND-AVC / RC31/21/0342
Conditions: Stroke
Keywords: brain-injured adult
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: University Hospital, ToulouseUniversity, hospital or other
Study start: 26 Mar 2024 (actual)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 15 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Task handover model #1	Experimental	Device: Putting on the gripping glove, Other: ULPA questionnaire, Other: Motor Activity Log (MAL) Questionnaire, Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire, Other: Score Action Arm Research Test, Other: EuroQol five-level (EQ-5D-5L) questionnaire, Other: Quebec User Evaluation of Satisfaction with Assistive Technology, Other: Psychosocial Impact of Assistive Devices Scale (PIADS), Other: Goal Attainment Scale (GAS), Other: installation and collection of accelerometersAt each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 1st model follows the following diagram: Visit T1 = AB; Visit T2 = AB; Visit T3 = AB
Task handover model #2	Experimental	Device: Putting on the gripping glove, Other: ULPA questionnaire, Other: Motor Activity Log (MAL) Questionnaire, Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire, Other: Score Action Arm Research Test, Other: EuroQol five-level (EQ-5D-5L) questionnaire, Other: Quebec User Evaluation of Satisfaction with Assistive Technology, Other: Psychosocial Impact of Assistive Devices Scale (PIADS), Other: Goal Attainment Scale (GAS), Other: installation and collection of accelerometersAt each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 2nd model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = AB
Task handover model #3	Experimental	Device: Putting on the gripping glove, Other: ULPA questionnaire, Other: Motor Activity Log (MAL) Questionnaire, Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire, Other: Score Action Arm Research Test, Other: EuroQol five-level (EQ-5D-5L) questionnaire, Other: Quebec User Evaluation of Satisfaction with Assistive Technology, Other: Psychosocial Impact of Assistive Devices Scale (PIADS), Other: Goal Attainment Scale (GAS), Other: installation and collection of accelerometersAt each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 3rd model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = AB
Task handover model #4	Experimental	Device: Putting on the gripping glove, Other: ULPA questionnaire, Other: Motor Activity Log (MAL) Questionnaire, Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire, Other: Score Action Arm Research Test, Other: EuroQol five-level (EQ-5D-5L) questionnaire, Other: Quebec User Evaluation of Satisfaction with Assistive Technology, Other: Psychosocial Impact of Assistive Devices Scale (PIADS), Other: Goal Attainment Scale (GAS), Other: installation and collection of accelerometersAt each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 4th model follows the following diagram: Visit T1 = AB ; Visit T2 = AB ; Visit T3 = BA
Task handover model #5	Experimental	Device: Putting on the gripping glove, Other: ULPA questionnaire, Other: Motor Activity Log (MAL) Questionnaire, Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire, Other: Score Action Arm Research Test, Other: EuroQol five-level (EQ-5D-5L) questionnaire, Other: Quebec User Evaluation of Satisfaction with Assistive Technology, Other: Psychosocial Impact of Assistive Devices Scale (PIADS), Other: Goal Attainment Scale (GAS), Other: installation and collection of accelerometersAt each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 5th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = AB
Task handover model #6	Experimental	Device: Putting on the gripping glove, Other: ULPA questionnaire, Other: Motor Activity Log (MAL) Questionnaire, Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire, Other: Score Action Arm Research Test, Other: EuroQol five-level (EQ-5D-5L) questionnaire, Other: Quebec User Evaluation of Satisfaction with Assistive Technology, Other: Psychosocial Impact of Assistive Devices Scale (PIADS), Other: Goal Attainment Scale (GAS), Other: installation and collection of accelerometersAt each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 6th model follows the following diagram: Visit T1 = BA ; Visit T2 = AB ; Visit T3 = BA
Task handover model #7	Experimental	Device: Putting on the gripping glove, Other: ULPA questionnaire, Other: Motor Activity Log (MAL) Questionnaire, Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire, Other: Score Action Arm Research Test, Other: EuroQol five-level (EQ-5D-5L) questionnaire, Other: Quebec User Evaluation of Satisfaction with Assistive Technology, Other: Psychosocial Impact of Assistive Devices Scale (PIADS), Other: Goal Attainment Scale (GAS), Other: installation and collection of accelerometersAt each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 7th model follows the following diagram: Visit T1 = AB ; Visit T2 = BA ; Visit T3 = BA
Task handover model #8	Experimental	Device: Putting on the gripping glove, Other: ULPA questionnaire, Other: Motor Activity Log (MAL) Questionnaire, Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire, Other: Score Action Arm Research Test, Other: EuroQol five-level (EQ-5D-5L) questionnaire, Other: Quebec User Evaluation of Satisfaction with Assistive Technology, Other: Psychosocial Impact of Assistive Devices Scale (PIADS), Other: Goal Attainment Scale (GAS), Other: installation and collection of accelerometersAt each visit, the patient will perform the tasks with the gripping glove (A) or without the gripping glove (B). The order of administration "with then without the glove (AB)" or "without then with the glove (BA)" is drawn at random for each patient. The 8th model follows the following diagram: Visit T1 = BA ; Visit T2 = BA ; Visit T3 = BA

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (14 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Putting on the gripping glovetaking measurements and putting the gripping glove on the patient	Device	Task handover model #1, Task handover model #2, Task handover model #3, Task handover model #4, Task handover model #5, Task handover model #6, Task handover model #7, Task handover model #8
ULPA questionnaireThe evaluation of the effectiveness of the gripping glove on the performance of the upper limb in daily life will be evaluated using the ULPA score. The investigator asks the patient to perform a task and the ULPA collects the total number of errors made by the patient (inability/omission, imprecision, repetition, time to complete the task)	Other	Task handover model #1, Task handover model #2, Task handover model #3, Task handover model #4, Task handover model #5, Task handover model #6, Task handover model #7, Task handover model #8
Motor Activity Log (MAL) QuestionnaireThe MAL is a self-assessment of the integration of the upper limb into daily life. This measurement allows a quantified evaluation of the perceived performance of the use of the upper limb in the actions of daily life. The patient will answer 30 questions about daily life and for each item, rate the quantity from 0 to 5: 0 = never uses the hemiplegic arm and 5 = uses as much as before the accident	Other	Task handover model #1, Task handover model #2, Task handover model #3, Task handover model #4, Task handover model #5, Task handover model #6, Task handover model #7, Task handover model #8
Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaireThis questionnaire assesses the motor selectivity of the upper limb. Several questions are asked about the movements that the patient can perform and to each question, the patient can answer either 0 (minimum) and 2 (maximum).	Other	Task handover model #1, Task handover model #2, Task handover model #3, Task handover model #4, Task handover model #5, Task handover model #6, Task handover model #7, Task handover model #8
Score Action Arm Research TestThis questionnaire evaluates 4 different actions: Grasping an object (6 different objects to grasp), holding an object (4 different objects), pinching an object (6 different objects) and the overall movements made by the patient (3 different overall movements). For each item, each object or each movement evaluated, the patient must rate the task on a scale of 0 to 3 (0=cannot perform any part of the test and 3=performs the test normally)	Other	Task handover model #1, Task handover model #2, Task handover model #3, Task handover model #4, Task handover model #5, Task handover model #6, Task handover model #7, Task handover model #8
EuroQol five-level (EQ-5D-5L) questionnaireThis questionnaire assesses the patient's state of health. 5 items are proposed (mobility, autonomy, current activity, pain, anxiety) and for each the patient must check one of the 5 propositions (no problem, mild problems, moderate problems, severe problems, incapable). The patient must also rate their state of health on a scale of 0 to 100.	Other	Task handover model #1, Task handover model #2, Task handover model #3, Task handover model #4, Task handover model #5, Task handover model #6, Task handover model #7, Task handover model #8
Quebec User Evaluation of Satisfaction with Assistive TechnologyThis questionnaire assesses satisfaction with the technical aid (here the gripping glove) and the related services. The technique and related services will be evaluated by items provided to the patient and he will have to rate for each of them a score between 1 and 5 (1 = not satisfied at all and 5 = very satisfied)	Other	Task handover model #1, Task handover model #2, Task handover model #3, Task handover model #4, Task handover model #5, Task handover model #6, Task handover model #7, Task handover model #8
Psychosocial Impact of Assistive Devices Scale (PIADS)This questionnaire measures the effect of technical aids on the psychosocial level. 26 sentences or words are offered to the patient concerning his psychological state and the patient must evaluate them between -3 and 3 (-3 = decreased and +3: increased)	Other	Task handover model #1, Task handover model #2, Task handover model #3, Task handover model #4, Task handover model #5, Task handover model #6, Task handover model #7, Task handover model #8
Goal Attainment Scale (GAS)Carrying out an activity in the patient's real context is assessed using the Goal Attainment Scale (GAS). The doctor gives the patient objectives to achieve and the patient must give the quotation for each objective between initial state (-2), expected result (0) and best possible result (2)	Other	Task handover model #1, Task handover model #2, Task handover model #3, Task handover model #4, Task handover model #5, Task handover model #6, Task handover model #7, Task handover model #8
installation and collection of accelerometersThe accelerometer quantitatively reports the spontaneous use of the upper limb in daily life. It counts the number of voluntary movements of the upper limbs. The amount of movement of the paretic upper limb will be expressed as a percentage of the movements of the non-paretic limb.	Other	Task handover model #1, Task handover model #2, Task handover model #3, Task handover model #4, Task handover model #5, Task handover model #6, Task handover model #7, Task handover model #8

Primary outcome

Evaluation of the effectiveness of the gripping glove
Time frame: 6 months
The evaluation of the effectiveness of the gripping glove on the performance of the upper limb in daily life will be evaluated using the ULPA score and compared between the 2 conditions (with and without the glove) in the performance of a daily activity.

8 secondary outcomes

Evaluation of the performance of an activity in the real context of the patient
Time frame: 6 months
Evaluation of factual spontaneous use of the upper limb in daily life
Time frame: 6 months
Evaluation of the perceived performance of the use of the paretic upper limb
Time frame: 6 months
Assessment of the quality of voluntary motor skills of the upper limb
Time frame: 6 months
Assessment of gripping abilities
Time frame: 6 months
Quality of life assessment
Time frame: 6 months
Evaluation of satisfaction and tolerance
Time frame: 6 months
Evaluation of the psycho-social impact
Time frame: 6 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Individual participant dataSharing planned: No

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Claire VILLEPINTE contact

0567771724 ext. +33

villepinte.c@chu-toulouse.fr

Audrey TOMASIK contact

0561778597 ext. +33

tomasik.a@chu-toulouse.fr

Claire VILLEPINTE principal investigator

University Hospital, Toulouse

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Putting on the gripping glove, ULPA questionnaire and Motor Activity Log (MAL) Questionnaire in people with Stroke, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claire VILLEPINTE (0567771724 ext. +33, villepinte.c@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the effectiveness of the gripping glove (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06312631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.