Arm 1
OtherMaterials used for the course :
- : Standard Wheelchair
- : Standard Wheelchair + Seat back + Positioning cushion
- : Standard Wheelchair + Seat back + Positioning cushion + Belt
NCT Number: NCT04268641
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Groupement Hospitalier Intercommunal du Vexin, Aincourt, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Materials used for the course :
Materials used for the course :
Materials used for the course :
Materials used for the course :
Materials used for the course :
Materials used for the course :
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Immediately after the end of the procedure, an average of 1 day
Binary criteria (Yes / No)
Time frame: Immediately after the end of the procedure, an average of 1 day
Total number of adverse event
Hôpital NOVO
Other
Evaluation of Positioning Protocols with an Adapted Equipment on a Wheelchair in Hemiplegic Patients Following a Stroke
Acronym: POSIT-HEMI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05823298
Brain Diseases, CVA (Cerebrovascular Accident)
Istanbul, Esenyurt, Turkey (Türkiye)
View Trial DetailsNCT07507552
Brain Diseases, Cardiovascular Diseases
View Trial DetailsNCT07053917
Brain Diseases, Brain Infarction
Baltimore, Maryland, United States
View Trial DetailsNCT07299162
Brain Diseases, Cardiovascular Diseases
Istanbul, Bahçelievler, Turkey (Türkiye)
View Trial Details