Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults
ECO-HAND-AVC
Benefits of a Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults: Comparative Multicenter Study
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Mar 2024
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedStudy Start
First participant enrolled
March 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
June 1, 2026
May 1, 2026
3.8 years
March 8, 2024
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (8)
Evaluation of the performance of an activity in the real context of the patient
6 months
Evaluation of factual spontaneous use of the upper limb in daily life
6 months
Evaluation of the perceived performance of the use of the paretic upper limb
6 months
Assessment of the quality of voluntary motor skills of the upper limb
6 months
Assessment of gripping abilities
6 months
- +3 more secondary outcomes
Study Arms (8)
Task handover model #1
EXPERIMENTALAt 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
EXPERIMENTALAt 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
EXPERIMENTALAt 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
EXPERIMENTALAt 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
EXPERIMENTALAt 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
EXPERIMENTALAt 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
EXPERIMENTALAt 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
EXPERIMENTALAt 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
Interventions
taking measurements and putting the gripping glove on the patient
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)
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
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).
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)
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.
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)
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)
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)
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.
Eligibility Criteria
You may qualify if:
- 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.
- Person affiliated to or beneficiary of a social security system.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Claire VILLEPINTE
Toulouse, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claire VILLEPINTE
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2024
First Posted
March 15, 2024
Study Start
March 26, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share