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

Stroke Clinical Trial

— ECO-HAND-AVC  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06312631
• Other study ID #: RC31/21/0342
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: University Hospital, Toulouse
• Contact: Claire VILLEPINTE
• Phone: 5 67 77 17 24
• Email: villepinte.c[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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.

Our 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Putting on the gripping glove
taking measurements and putting the gripping glove on the patient

Other:
• ULPA questionnaire
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) Questionnaire
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) questionnaire
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 Test
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) questionnaire
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 Technology
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)
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)
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 accelerometers
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.

Locations

Country	Name	City	State
France	Claire VILLEPINTE	Toulouse	CHU De Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months
Secondary	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).	6 months
Secondary	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).	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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).	6 months
Secondary	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).	6 months
Secondary	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.	6 months