Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients

Not Applicable

Completed

• Conditions: Hemiplegia And/or Hemiparesis Following Stroke
• Interventions: Other: Arm 5; Other: Arm 3; Other: Arm 1; Other: Arm 4; Other: Arm 2; Other: Arm 6

• Registration Number: NCT04268641
• Lead Sponsor: Hôpital NOVO

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

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-13
• Study Start: 2020-08-28
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Use of positioning equipment order 5	Arm 5	One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.
Use of positioning equipment order 3	Arm 3	One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.
Use of positioning equipment order 1	Arm 1	One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.
Use of positioning equipment order 4	Arm 4	One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.
Use of positioning equipment order 2	Arm 2	One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.
Use of positioning equipment order 6	Arm 6	One standardized course is performed 3 times by each patient : one with a standard wheelchair and the 2 other with one or two positioning equipment (Seat back or/and positioning cushion) Each arm differs from the previous by the order of use of the equipment.

Primary Outcome Measures

Name	Time	Method
Degree of pelvic posterior tilt	Immediately after the end of the procedure, an average of 1 day	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)

Secondary Outcome Measures

Name	Time	Method
Variation of the degree of Pelvis obliquity	Baseline and immediately after the end of the procedure, an average of 1 day	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)
Degree of lateral inclination of the torso	Immediately after the end of the procedure, an average of 1 day	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)
Degree of Pelvis obliquity	Immediately after the end of the procedure, an average of 1 day	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)
Measure of patient's satisfaction	Immediately after the end of the procedure, an average of 1 day	The satisfaction of patient was measured with a satisfaction questionnaire scale based on ease of movement, wheelchair comfort and pain during the course. For each item, patient ticks : Very satisfied, Satisfied, Neither satisfied or unsatisfied, Unsatisfied or Very unsatisfied
Variation of Degree of pelvic posterior tilt	Baseline and immediately after the end of the procedure, an average of 1 day	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)
Variation of degree of lateral inclination of the torso	Baseline and immediately after the end of the procedure, an average of 1 day	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)
Adverse event collect	Immediately after the end of the procedure, an average of 1 day	Total number of adverse event
Ability to achieve the whole course	Immediately after the end of the procedure, an average of 1 day	Binary criteria (Yes / No)

Trial Locations

Locations (7)

Groupement Hospitalier Intercommunal du Vexin; 🇫🇷 Aincourt, France

Centre de l'ESPOIR; 🇫🇷 Lille, France

Hôpital Raymond Poincaré; 🇫🇷 Garche, France

Institut Régional de Réadaptation; 🇫🇷 Lay-Saint-Christophe, France

Centre de Rééducation L'oiseau Blanc; 🇫🇷 Mantes-la-Jolie, France

Centre Hospitalier Universitaire de Toulouse; 🇫🇷 Toulouse, France

Centre de Rééducation et de Réadaptation Fonctionnelles; 🇫🇷 Menucourt, France