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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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°;

Trial design

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators