Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients

Study Overview
=================
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

Official Title
-----------------
Evaluation of Positioning Protocols With an Adapted Equipment on a Wheelchair in Hemiplegic Patients Following a Stroke

Conditions
-----------------
Hemiplegia and/or Hemiparesis Following Stroke

Intervention / Treatment
-----------------
* Other: Arm 1
* Other: Arm 2
* Other: Arm 3
* Other: Arm 4
* Other: Arm 5
* Other: Arm 6


Participation Criteria
=================
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…)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of positioning equipment order 1<br>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. | Other: Arm 1<br>* Materials used for the course : : Standard Wheelchair : Standard Wheelchair + Seat back + Positioning cushion : Standard Wheelchair + Seat back + Positioning cushion + Belt<br>|
| Experimental: Use of positioning equipment order 2<br>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. | Other: Arm 2<br>* Materials used for the course : : Standard Wheelchair : Standard Wheelchair + Seat back + Positioning cushion + Belt : Standard Wheelchair + Seat back + Positioning cushion<br>|
| Experimental: Use of positioning equipment order 3<br>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. | Other: Arm 3<br>* Materials used for the course : : Standard Wheelchair + Seat back + Positioning cushion : Standard Wheelchair + Seat back + Positioning cushion + Belt : Standard Wheelchair<br>|
| Experimental: Use of positioning equipment order 4<br>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. | Other: Arm 4<br>* Materials used for the course : : Standard Wheelchair + Seat back + Positioning cushion : Standard Wheelchair : Standard Wheelchair + Seat back + Positioning cushion + Belt<br>|
| Experimental: Use of positioning equipment order 5<br>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. | Other: Arm 5<br>* Materials used for the course : : Standard Wheelchair + Seat back + Positioning cushion + Belt : Standard Wheelchair : Standard Wheelchair + Seat back + Positioning cushion<br>|
| Experimental: Use of positioning equipment order 6<br>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. | Other: Arm 6<br>* Materials used for the course : : Standard Wheelchair + Seat back + Positioning cushion + Belt : Standard Wheelchair + Seat back + Positioning cushion : Standard Wheelchair<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Immediately after the end of the procedure, an average of 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | Immediately after the end of the procedure, an average of 1 day | 
| Degree of Pelvis obliquity | 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) | Immediately after the end of the procedure, an average of 1 day | 
| Measure of patient's satisfaction | 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 | Immediately after the end of the procedure, an average of 1 day | 
| Ability to achieve the whole course | Binary criteria (Yes / No) | Immediately after the end of the procedure, an average of 1 day | 
| Adverse event collect | Total number of adverse event | Immediately after the end of the procedure, an average of 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemiplegia, Stroke, Wheelchair positioning, Propulsion, Pelvic posterior tilt, Obliquity