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Résztvevőt keres itt: FranciaországFázis nélkül

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

A legfontosabb adatok

Ki végzi
University Hospital, Toulouse
Hol
Toulouse (Franciaország)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
100 fő, tervezett
Kezdés
2024. márc. 26.
Várható befejezés
2027. dec. 31.
A vizsgálat típusa
Beavatkozással járó, 8 csoport
A vizsgált kezelések
  • Putting on the gripping glove
  • ULPA questionnaire
  • Motor Activity Log (MAL) Questionnaire
  • Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire
  • Score Action Arm Research Test
  • EuroQol five-level (EQ-5D-5L) questionnaire
  • Quebec User Evaluation of Satisfaction with Assistive Technology
  • Psychosocial Impact of Assistive Devices Scale (PIADS)
  • Goal Attainment Scale (GAS)
  • installation and collection of accelerometers
A regiszteradat frissítve
2026. június 1.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akiknek több mint három hónapja volt agyvérzésük vagy szélütésük, és nem tudják aktívan kinyitni az ujjaikat, hogy megfogjanak egy poharat. Otthon egy fogást segítő kesztyűt próbálnak ki.

Életkor
18–90 év
Nem
Nemtől függetlenül részt vehet.
A betegség stádiuma
Kargyengeség agyi érkatasztrófa (iszkémiás vagy vérzéses, agyi képalkotással igazolt) után, amely több mint három hónapja történt.

A részvétel fő kizáró okai

  • Merev vagy megrövidült ujjak vagy csukló, amelyek megakadályozzák az ujjak teljes kinyitását
  • Közepes vagy súlyos izomfeszesség a csuklóban és az ujjakban (Modified Ashworth Scale ≥ 3)
  • Súlyos afázia (BDAE ≤ 3)
  • Latexallergia
  • Terhes vagy szoptató nők

A regiszter feltételei, szó szerint

Mind a 22 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • Patient allergic to Latex
  • History of upper limb surgery less than 6 months old
  • 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
  • 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

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 90 év között vagy?

Helyszínek itt: Franciaország

  • Claire VILLEPINTEToulouse, FranciaországContact: Claire VILLEPINTERésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 8 csoportja

  • Task handover model #1A vizsgált kezelés

    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

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

  • Task handover model #2A vizsgált kezelés

    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

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

  • Task handover model #3A vizsgált kezelés

    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

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

  • Task handover model #4A vizsgált kezelés

    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

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

  • Task handover model #5A vizsgált kezelés

    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

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

  • Task handover model #6A vizsgált kezelés

    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

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

  • Task handover model #7A vizsgált kezelés

    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

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

  • Task handover model #8A vizsgált kezelés

    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

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

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Benefits of a Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults: Comparative Multicenter Study
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
Illeszkedési kérdések
Forrás: NCT06312631: ki vehet részt
A regiszteradat frissítve
2026. június 1.