An interventional study of Putting on the gripping glove and ULPA questionnaire in Stroke, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Other
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
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Exclusion Criteria:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
Time frame: 6 months
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 6 months
Plan to share: No
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University Hospital, Toulouse