Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients

Hemiplegia and/or Hemiparesis Following Stroke Clinical Trial

— POSIT-HEMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268641
• Other study ID #: GHIV0417
• Status: Completed
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: December 11, 2023

Study information

• Verified date: January 2024
• Source: Hôpital NOVO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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…)

Related Conditions & MeSH terms

• Hemiplegia
• Hemiplegia and/or Hemiparesis Following Stroke
• Paresis
• Stroke

Intervention

Other:
• Arm 1
Materials used for the course : : Standard Wheelchair : Standard Wheelchair + Seat back + Positioning cushion : Standard Wheelchair + Seat back + Positioning cushion + Belt
• Arm 2
Materials used for the course : : Standard Wheelchair : Standard Wheelchair + Seat back + Positioning cushion + Belt : Standard Wheelchair + Seat back + Positioning cushion
• Arm 3
Materials used for the course : : Standard Wheelchair + Seat back + Positioning cushion : Standard Wheelchair + Seat back + Positioning cushion + Belt : Standard Wheelchair
• Arm 4
Materials used for the course : : Standard Wheelchair + Seat back + Positioning cushion : Standard Wheelchair : Standard Wheelchair + Seat back + Positioning cushion + Belt
• Arm 5
Materials used for the course : : Standard Wheelchair + Seat back + Positioning cushion + Belt : Standard Wheelchair : Standard Wheelchair + Seat back + Positioning cushion
• Arm 6
Materials used for the course : : Standard Wheelchair + Seat back + Positioning cushion + Belt : Standard Wheelchair + Seat back + Positioning cushion : Standard Wheelchair

Locations

Country	Name	City	State
France	Groupement Hospitalier Intercommunal du Vexin	Aincourt
France	Hôpital Raymond Poincaré	Garche
France	Institut Régional de Réadaptation	Lay-Saint-Christophe
France	Centre de l'ESPOIR	Lille
France	Centre de Rééducation L'oiseau Blanc	Mantes-la-Jolie
France	Centre de Rééducation et de Réadaptation Fonctionnelles	Menucourt
France	Centre Hospitalier Universitaire de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital NOVO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Ability to achieve the whole course	Binary criteria (Yes / No)	Immediately after the end of the procedure, an average of 1 day
Secondary	Adverse event collect	Total number of adverse event	Immediately after the end of the procedure, an average of 1 day