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Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults (ECO-HAND-AVC)

T

Toulouse University Hospital

Status

Enrolling

Conditions

Stroke

Treatments

Other: Goal Attainment Scale (GAS)
Other: Score Action Arm Research Test
Other: Psychosocial Impact of Assistive Devices Scale (PIADS)
Other: Quebec User Evaluation of Satisfaction with Assistive Technology
Other: ULPA questionnaire
Device: Putting on the gripping glove
Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire
Other: EuroQol five-level (EQ-5D-5L) questionnaire
Other: installation and collection of accelerometers
Other: Motor Activity Log (MAL) Questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT06312631
RC31/21/0342

Details and patient eligibility

About

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.

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Enrollment

100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

100 participants in 8 patient groups

Task handover model #1
Experimental group
Description:
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
Treatment:
Other: Motor Activity Log (MAL) Questionnaire
Other: installation and collection of accelerometers
Other: EuroQol five-level (EQ-5D-5L) questionnaire
Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire
Device: Putting on the gripping glove
Other: ULPA questionnaire
Other: Psychosocial Impact of Assistive Devices Scale (PIADS)
Other: Quebec User Evaluation of Satisfaction with Assistive Technology
Other: Score Action Arm Research Test
Other: Goal Attainment Scale (GAS)
Task handover model #2
Experimental group
Description:
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
Treatment:
Other: Motor Activity Log (MAL) Questionnaire
Other: installation and collection of accelerometers
Other: EuroQol five-level (EQ-5D-5L) questionnaire
Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire
Device: Putting on the gripping glove
Other: ULPA questionnaire
Other: Psychosocial Impact of Assistive Devices Scale (PIADS)
Other: Quebec User Evaluation of Satisfaction with Assistive Technology
Other: Score Action Arm Research Test
Other: Goal Attainment Scale (GAS)
Task handover model #3
Experimental group
Description:
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
Treatment:
Other: Motor Activity Log (MAL) Questionnaire
Other: installation and collection of accelerometers
Other: EuroQol five-level (EQ-5D-5L) questionnaire
Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire
Device: Putting on the gripping glove
Other: ULPA questionnaire
Other: Psychosocial Impact of Assistive Devices Scale (PIADS)
Other: Quebec User Evaluation of Satisfaction with Assistive Technology
Other: Score Action Arm Research Test
Other: Goal Attainment Scale (GAS)
Task handover model #4
Experimental group
Description:
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
Treatment:
Other: Motor Activity Log (MAL) Questionnaire
Other: installation and collection of accelerometers
Other: EuroQol five-level (EQ-5D-5L) questionnaire
Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire
Device: Putting on the gripping glove
Other: ULPA questionnaire
Other: Psychosocial Impact of Assistive Devices Scale (PIADS)
Other: Quebec User Evaluation of Satisfaction with Assistive Technology
Other: Score Action Arm Research Test
Other: Goal Attainment Scale (GAS)
Task handover model #5
Experimental group
Description:
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
Treatment:
Other: Motor Activity Log (MAL) Questionnaire
Other: installation and collection of accelerometers
Other: EuroQol five-level (EQ-5D-5L) questionnaire
Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire
Device: Putting on the gripping glove
Other: ULPA questionnaire
Other: Psychosocial Impact of Assistive Devices Scale (PIADS)
Other: Quebec User Evaluation of Satisfaction with Assistive Technology
Other: Score Action Arm Research Test
Other: Goal Attainment Scale (GAS)
Task handover model #6
Experimental group
Description:
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
Treatment:
Other: Motor Activity Log (MAL) Questionnaire
Other: installation and collection of accelerometers
Other: EuroQol five-level (EQ-5D-5L) questionnaire
Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire
Device: Putting on the gripping glove
Other: ULPA questionnaire
Other: Psychosocial Impact of Assistive Devices Scale (PIADS)
Other: Quebec User Evaluation of Satisfaction with Assistive Technology
Other: Score Action Arm Research Test
Other: Goal Attainment Scale (GAS)
Task handover model #7
Experimental group
Description:
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
Treatment:
Other: Motor Activity Log (MAL) Questionnaire
Other: installation and collection of accelerometers
Other: EuroQol five-level (EQ-5D-5L) questionnaire
Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire
Device: Putting on the gripping glove
Other: ULPA questionnaire
Other: Psychosocial Impact of Assistive Devices Scale (PIADS)
Other: Quebec User Evaluation of Satisfaction with Assistive Technology
Other: Score Action Arm Research Test
Other: Goal Attainment Scale (GAS)
Task handover model #8
Experimental group
Description:
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
Treatment:
Other: Motor Activity Log (MAL) Questionnaire
Other: installation and collection of accelerometers
Other: EuroQol five-level (EQ-5D-5L) questionnaire
Other: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire
Device: Putting on the gripping glove
Other: ULPA questionnaire
Other: Psychosocial Impact of Assistive Devices Scale (PIADS)
Other: Quebec User Evaluation of Satisfaction with Assistive Technology
Other: Score Action Arm Research Test
Other: Goal Attainment Scale (GAS)

Trial contacts and locations

1

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Central trial contact

Claire VILLEPINTE; Audrey TOMASIK

Data sourced from clinicaltrials.gov

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