Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT06312631

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

Led by University Hospital, Toulouse · Updated on 2024-09-26

100

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 to voluntarily grasp an empty glass (7 cm upper diameter, 6 cm lower diameter, 12-15 cm height, 125g weight) with a palmar grip, but can hold the glass passively
  • Patient capable of passively opening the hand enough to grasp the glass when wearing the gripping glove, with the ability to actively close the hand
  • Patient able to put on and remove the SaeboGlove gripping glove with help if needed
  • Patient has a smartphone, tablet, and/or computer compatible with video and teleconsultation
  • Free, informed, and signed consent by the participant and/or guardian and the investigator before any required examination
  • Person affiliated to or beneficiary of a social security system
Not Eligible

You will not qualify if you...

  • Retraction or stiffness of fingers and wrist preventing complete extension of long fingers and thumb, wrist at 15° extension
  • Moderate or severe muscular spasticity of wrist flexors and finger/thumb flexors (Modified Ashworth Scale ≥ 3)
  • Limited active elbow extension preventing reaching ipsilateral knee with the hand while seated with trunk vertical
  • Active anterior shoulder elevation range less than 15°
  • Other upper limb deficiencies affecting participation
  • No access to teleconsultation or cannot be reached remotely
  • Severe aphasia (Boston Diagnostic Aphasia Examination ≤ 3)
  • Moderate or severe edema localized to wrist and hand
  • Allergy to Latex
  • Upper limb surgery less than 6 months ago
  • Pregnant or breastfeeding women
  • Patient deprived of liberty (detained/incarcerated)
  • Patient under judicial protection
  • Unable to give informed consent or comply due to impaired physical or psychological health

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Claire VILLEPINTE

Toulouse, France

Actively Recruiting

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Research Team

C

Claire VILLEPINTE

CONTACT

A

Audrey TOMASIK

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

8

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