Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients

Hôpital NOVO24 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Hemiplegia And/or Hemiparesis Following Stroke

Interventions

Arm 1OTHER

Materials used for the course : 1. : Standard Wheelchair 2. : Standard Wheelchair + Seat back + Positioning cushion 3. : Standard Wheelchair + Seat back + Positioning cushion + Belt

Arm 2OTHER

Materials used for the course : 1. : Standard Wheelchair 2. : Standard Wheelchair + Seat back + Positioning cushion + Belt 3. : Standard Wheelchair + Seat back + Positioning cushion

Arm 3OTHER

Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion 2. : Standard Wheelchair + Seat back + Positioning cushion + Belt 3. : Standard Wheelchair

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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…)

Locations (7)

Groupement Hospitalier Intercommunal du Vexin

Aincourt, France

Hôpital Raymond Poincaré

Garche, France

Institut Régional de Réadaptation

Lay-Saint-Christophe, France

Centre de l'ESPOIR

Lille, France

Outcomes

Primary Outcomes

Degree of pelvic posterior tilt

The Primary Outcome Measure is the variation of the Degree of pelvic posterior tilt at the end of the three standardized course. These courses were performed with Standard Wheelchair, Standard Wheelchair + Seat back + Positioning cushion + Belt or with Standard Wheelchair + Seat back + Positioning cushion. The Degree of pelvic posterior tilt was measured using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 = moderate and 3 = severe retroversion)

Time frame: Immediately after the end of the procedure, an average of 1 day

Secondary Outcomes

Variation of Degree of pelvic posterior tilt

The variation of the Degree of pelvic posterior tilt was measured between the beginning and the end of the three standardized course using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 = moderate and 3 = severe retroversion)

Time frame: Baseline and immediately after the end of the procedure, an average of 1 day

Variation of degree of lateral inclination of the torso

The variation of the degree of lateral inclination of the torso was measured between the beginning and the end of the three standardized course using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 = moderate and 3 = severe retroversion)

Time frame: Baseline and immediately after the end of the procedure, an average of 1 day

Variation of the degree of Pelvis obliquity

The variation of the degree of Pelvis obliquity was measured at the end of the three standardized course using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 =moderate and 3 = severe retroversion)

Time frame: Baseline and immediately after the end of the procedure, an average of 1 day

Degree of lateral inclination of the torso

The degree of lateral inclination of the torso was measured at the end of the three standardized course using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 = moderate and 3 = severe retroversion)

Data from ClinicalTrials.gov

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