Hemiplegia And/or Hemiparesis Following Stroke
Conditions
Keywords
Hemiplegia, Stroke, Wheelchair positioning, Propulsion, Pelvic posterior tilt, Obliquity
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
Interventions
OTHERArm 1
Materials used for the course : 1. : Standard Wheelchair 2. : Standard Wheelchair + Seat back + Positioning cushion 3. : Standard Wheelchair + Seat back + Positioning cushion + Belt
OTHERArm 2
Materials used for the course : 1. : Standard Wheelchair 2. : Standard Wheelchair + Seat back + Positioning cushion + Belt 3. : Standard Wheelchair + Seat back + Positioning cushion
OTHERArm 3
Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion 2. : Standard Wheelchair + Seat back + Positioning cushion + Belt 3. : Standard Wheelchair
OTHERArm 4
Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion 2. : Standard Wheelchair 3. : Standard Wheelchair + Seat back + Positioning cushion + Belt
OTHERArm 5
Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion + Belt 2. : Standard Wheelchair 3. : Standard Wheelchair + Seat back + Positioning cushion
OTHERArm 6
Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion + Belt 2. : Standard Wheelchair + Seat back + Positioning cushion 3. : Standard Wheelchair
Sponsors
Hôpital NOVO
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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 |
| Ability to achieve the whole course | Immediately after the end of the procedure, an average of 1 day | Binary criteria (Yes / No) |
| Adverse event collect | Immediately after the end of the procedure, an average of 1 day | Total number of adverse event |
| 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) |
Countries
France
Outcome results
None listed