An interventional study of Arm 1 and Arm 2 in Hemiplegia And/or Hemiparesis Following Stroke, sponsored by Hôpital NOVO. Completed at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Hôpital NOVO · Not applicable, Interventional, and Supportive care
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
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Hôpital NOVO is the lead sponsor of 69 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
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
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
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
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
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
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
Materials used for the course : 1. : Standard Wheelchair 2. : Standard Wheelchair + Seat back + Positioning cushion 3. : Standard Wheelchair + Seat back + Positioning cushion + Belt
Materials used for the course : 1. : Standard Wheelchair 2. : Standard Wheelchair + Seat back + Positioning cushion + Belt 3. : Standard Wheelchair + Seat back + Positioning cushion
Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion 2. : Standard Wheelchair + Seat back + Positioning cushion + Belt 3. : Standard Wheelchair
Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion 2. : Standard Wheelchair 3. : Standard Wheelchair + Seat back + Positioning cushion + Belt
Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion + Belt 2. : Standard Wheelchair 3. : Standard Wheelchair + Seat back + Positioning cushion
Materials used for the course : 1. : Standard Wheelchair + Seat back + Positioning cushion + Belt 2. : Standard Wheelchair + Seat back + Positioning cushion 3. : Standard Wheelchair
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
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)
Time frame: 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)
Time frame: 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
Time frame: Immediately after the end of the procedure, an average of 1 day
Ability to achieve the whole course
Binary criteria (Yes / No)
Time frame: Immediately after the end of the procedure, an average of 1 day
Adverse event collect
Total number of adverse event
Time frame: Immediately after the end of the procedure, an average of 1 day
Plan to share: No
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