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

Primary Purpose

Hemiplegia and/or Hemiparesis Following Stroke

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Sponsored by
Hôpital NOVO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemiplegia and/or Hemiparesis Following Stroke focused on measuring Hemiplegia, Stroke, Wheelchair positioning, Propulsion, Pelvic posterior tilt, Obliquity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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…)

Sites / Locations

  • Groupement Hospitalier Intercommunal du VexinRecruiting
  • Centre Sainte Barbe
  • Hôpital Raymond PoincaréRecruiting
  • Institut Régional de Réadaptation
  • Centre de l'ESPOIRRecruiting
  • Centre de Rééducation L'oiseau Blanc
  • Centre de Rééducation et de Réadaptation FonctionnellesRecruiting
  • Centre Hospitalier Universitaire de ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Use of positioning equipment order 1

Use of positioning equipment order 2

Use of positioning equipment order 3

Use of positioning equipment order 4

Use of positioning equipment order 5

Use of positioning equipment order 6

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)
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)
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
Ability to achieve the whole course
Binary criteria (Yes / No)
Adverse event collect
Total number of adverse event

Full Information

First Posted
February 10, 2020
Last Updated
September 8, 2023
Sponsor
Hôpital NOVO
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1. Study Identification

Unique Protocol Identification Number
NCT04268641
Brief Title
Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients
Acronym
POSIT-HEMI
Official Title
Evaluation of Positioning Protocols With an Adapted Equipment on a Wheelchair in Hemiplegic Patients Following a Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital NOVO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia and/or Hemiparesis Following Stroke
Keywords
Hemiplegia, Stroke, Wheelchair positioning, Propulsion, Pelvic posterior tilt, Obliquity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Use of positioning equipment order 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Use of positioning equipment order 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Use of positioning equipment order 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Use of positioning equipment order 4
Arm Type
Experimental
Arm Description
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.
Arm Title
Use of positioning equipment order 5
Arm Type
Experimental
Arm Description
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.
Arm Title
Use of positioning equipment order 6
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Arm 1
Intervention Description
Materials used for the course : : Standard Wheelchair : Standard Wheelchair + Seat back + Positioning cushion : Standard Wheelchair + Seat back + Positioning cushion + Belt
Intervention Type
Other
Intervention Name(s)
Arm 2
Intervention Description
Materials used for the course : : Standard Wheelchair : Standard Wheelchair + Seat back + Positioning cushion + Belt : Standard Wheelchair + Seat back + Positioning cushion
Intervention Type
Other
Intervention Name(s)
Arm 3
Intervention Description
Materials used for the course : : Standard Wheelchair + Seat back + Positioning cushion : Standard Wheelchair + Seat back + Positioning cushion + Belt : Standard Wheelchair
Intervention Type
Other
Intervention Name(s)
Arm 4
Intervention Description
Materials used for the course : : Standard Wheelchair + Seat back + Positioning cushion : Standard Wheelchair : Standard Wheelchair + Seat back + Positioning cushion + Belt
Intervention Type
Other
Intervention Name(s)
Arm 5
Intervention Description
Materials used for the course : : Standard Wheelchair + Seat back + Positioning cushion + Belt : Standard Wheelchair : Standard Wheelchair + Seat back + Positioning cushion
Intervention Type
Other
Intervention Name(s)
Arm 6
Intervention Description
Materials used for the course : : Standard Wheelchair + Seat back + Positioning cushion + Belt : Standard Wheelchair + Seat back + Positioning cushion : Standard Wheelchair
Primary Outcome Measure Information:
Title
Degree of pelvic posterior tilt
Description
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
Secondary Outcome Measure Information:
Title
Variation of Degree of pelvic posterior tilt
Description
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
Title
Variation of degree of lateral inclination of the torso
Description
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
Title
Variation of the degree of Pelvis obliquity
Description
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
Title
Degree of lateral inclination of the torso
Description
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
Title
Degree of Pelvis obliquity
Description
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
Title
Measure of patient's satisfaction
Description
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
Title
Ability to achieve the whole course
Description
Binary criteria (Yes / No)
Time Frame
Immediately after the end of the procedure, an average of 1 day
Title
Adverse event collect
Description
Total number of adverse event
Time Frame
Immediately after the end of the procedure, an average of 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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…)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryline DELATTRE
Phone
0033130754131
Email
maryline.delattre@ght-novo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique DA COSTA
Phone
0033130755069
Email
veronique.dacosta@ght-novo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Pellegrini
Organizational Affiliation
Groupement Hospitalier Intercommunal du Vexin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupement Hospitalier Intercommunal du Vexin
City
Aincourt
ZIP/Postal Code
95510
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Da Costa
Phone
+33 1 30 75 50 69
Email
veronique.dacosta@ght-novo.fr
First Name & Middle Initial & Last Name & Degree
Nadine Pellegrini
Facility Name
Centre Sainte Barbe
City
Fouquières-Lès-Lens
ZIP/Postal Code
62740
Country
France
Individual Site Status
Withdrawn
Facility Name
Hôpital Raymond Poincaré
City
Garche
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaud Lansaman
Phone
+33 1 47 10 70 60
Email
thibaud.lansaman@aphp.fr
Facility Name
Institut Régional de Réadaptation
City
Lay-Saint-Christophe
ZIP/Postal Code
54690
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre de l'ESPOIR
City
Lille
ZIP/Postal Code
59260
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Coulomb
Phone
+33 3 20 05 85 00
Ext
87 42
Email
alexandre.coulomb@centre-espoir.com
First Name & Middle Initial & Last Name & Degree
Alexandre Coulomb
Facility Name
Centre de Rééducation L'oiseau Blanc
City
Mantes-la-Jolie
ZIP/Postal Code
78200
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre de Rééducation et de Réadaptation Fonctionnelles
City
Menucourt
ZIP/Postal Code
95180
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Fattal
Phone
+33 1 34 46 65 65
Email
cfattal@lachataigneraie.fr
First Name & Middle Initial & Last Name & Degree
Charles Fattal
Facility Name
Centre Hospitalier Universitaire de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Terracol
Phone
+33 5 61 32 23 75
Email
terracol.c@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Caroline Terracol

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients

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