Clinical trial NCT04268641: Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients
Official title: Evaluation of Positioning Protocols with an Adapted Equipment on a Wheelchair in Hemiplegic Patients Following a Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia And/or Hemiparesis Following Stroke
Keywords: Hemiplegia
Stroke
Wheelchair positioning
Propulsion
Pelvic posterior tilt
Obliquity
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main purpose of this study is to assess the interest of using wheelchair positioning equipment on the decrease of postural disorders, compared to the standard use of a wheelchair

Detailed description: The stroke is the main cause of hemiplegia in developed countries. Fifteen percent of people who say they have a stroke need, at home, a wheelchair to get from one room to another. The use of a wheelchair can cause postural disorders which can lead to pain, orthopedic deformity and pressure ulcers.

This study aims to assess the interest of using wheelchair positioning equipment (Seat back, Positioning cushion and Belt) on the decrease of postural disorders.

This decrease will be assessed after a standardized course, performed under three different conditions: with the positioning equipment (Positioning cushion and Seat back), with the positioning equipment and the belt and with the wheelchair alone.

Clinical tool used to assess the decrease is the Seated Postural Control Measure for Adults 2.0 (SPCMA 2.0).

This study, which will be the first prospective, interventional, multicenter, controlled and randomized study, could pave the way for guidelines of good practice, for wheelchair positioning of hemiplegic patients in France

Eligibility criteria: Inclusion Criteria:

* Hemiplegic patient following a stroke
* Hospitalized in a follow-up and rehabilitative care service, after hospital stays in a MCO service (neurology, neurosurgery or reanimation)
* With a planned exit from hospital (homecoming, residential care facilities, nursing home, Long Term Care Unit ...)
* Patient whose wheelchair choice should be already done
* Patient who propels the wheelchair with the valid hand and/or valid foot
* Written informed consent (IC) obtained
* Patients with affiliation to the social security system

Exclusion Criteria:

* Good walk recovery (FAC scale \>3)
* Wheelchair with a double hand rim
* Patient who cannot use his2 wheelchair independently
* Cognitive disorders which prevent the ability to well understanding the instructions
* Other pathology which can interfere with this protocol (Spinal disorder, morbid overweight (BMI\>40...)

Primary outcomes:
measure: Degree of pelvic posterior tilt
timeFrame: Immediately after the end of the procedure, an average of 1 day
Secondary outcomes:
measure: Variation of Degree of pelvic posterior tilt
timeFrame: Baseline and immediately after the end of the procedure, an average of 1 day
measure: Variation of degree of lateral inclination of the torso
timeFrame: Baseline and immediately after the end of the procedure, an average of 1 day
measure: Variation of the degree of Pelvis obliquity
timeFrame: Baseline and immediately after the end of the procedure, an average of 1 day
measure: Degree of lateral inclination of the torso
timeFrame: Immediately after the end of the procedure, an average of 1 day
measure: Degree of Pelvis obliquity
timeFrame: Immediately after the end of the procedure, an average of 1 day
measure: Measure of patient's satisfaction
timeFrame: Immediately after the end of the procedure, an average of 1 day
measure: Ability to achieve the whole course
timeFrame: Immediately after the end of the procedure, an average of 1 day
measure: Adverse event collect
timeFrame: Immediately after the end of the procedure, an average of 1 day
Other outcomes:
Locations:
city: Aincourt
country: France
facility: Groupement Hospitalier Intercommunal du Vexin
city: Garche
country: France
facility: Hôpital Raymond Poincaré
city: Lay-Saint-Christophe
country: France
facility: Institut Régional de Réadaptation
city: Lille
country: France
facility: Centre de l'ESPOIR
city: Mantes-la-Jolie
country: France
facility: Centre de Rééducation L'oiseau Blanc
city: Menucourt
country: France
facility: Centre de Rééducation et de Réadaptation Fonctionnelles
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
Study officials:
affiliation: Groupement Hospitalier Intercommunal du Vexin
name: Nadine Pellegrini
role: PRINCIPAL_INVESTIGATOR
References: