NCT06312631

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

Benefits of a Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults: Comparative Multicenter Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
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)
OTHER	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
OTHER	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).
OTHER	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)
OTHER	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.
OTHER	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)
OTHER	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	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	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.

Timeline

• Start date: 2024-03-26
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-03-15
• Last updated: 2024-09-26

Locations

1 site across 1 country: France