Claire VILLEPINTE
Toulouse, France
Location status: Recruiting
Location contact
Audrey TOMASIK
CONTACT
0561778597 ext. +33
Claire VILLEPINTE
CONTACT
0567771724 ext. +33
Claire VILLEPINTE, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06312631
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Toulouse, France
Location status: Recruiting
Audrey TOMASIK
CONTACT
0561778597 ext. +33
Claire VILLEPINTE
CONTACT
0567771724 ext. +33
Claire VILLEPINTE, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 months
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.
Time frame: 6 months
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).
Time frame: 6 months
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).
Time frame: 6 months
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.
Time frame: 6 months
Grasping abilities will be assessed by the ARAT at T0, T2 (3 months) and T3 (6 months), without wearing the gripping glove.
Time frame: 6 months
Quality of life, assessed using the EQ-5D-5L, will be explored at T0, T2 (3 months) and T3 (6 months).
Time frame: 6 months
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).
Time frame: 6 months
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.
Contact information is provided by the study sponsor or research team.
University Hospital, Toulouse
Other
Benefits of a Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults: Comparative Multicenter Study
Acronym: ECO-HAND-AVC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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