Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients (POSIT-HEMI)

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

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

Study Overview

• Status: Completed
• 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

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maryline DELATTRE; Phone Number: 0033130754131; Email: maryline.delattre@ght-novo.fr
• Study Contact Backup: Name: Véronique DA COSTA; Phone Number: 0033130755069; Email: veronique.dacosta@ght-novo.fr

Study Locations

• France
  • Aincourt, France, 95510
    • Groupement Hospitalier Intercommunal du Vexin
  • Garche, France, 92380
    • Hôpital Raymond Poincaré
  • Lay-Saint-Christophe, France, 54690
    • Institut Régional de Réadaptation
  • Lille, France, 59260
    • Centre de l'ESPOIR
  • Mantes-la-Jolie, France, 78200
    • Centre de Rééducation L'oiseau Blanc
  • Menucourt, France, 95180
    • Centre de Rééducation et de Réadaptation Fonctionnelles
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Hôpital NOVO
• Investigators: Principal Investigator: Nadine Pellegrini, Groupement Hospitalier Intercommunal du Vexin

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2020
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Hemiplegia; Propulsion; Wheelchair positioning; Pelvic posterior tilt; Obliquity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia; Paresis
• Other Study ID Numbers: GHIV0417

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No