Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients

NCT ID: NCT04268641

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-28
• Study Completion Date: 2023-12-11

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

Conditions

Hemiplegia And/or Hemiparesis Following Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Arm 1

Intervention Type: OTHER

Materials used for the course :

1. : Standard Wheelchair

2. : Standard Wheelchair + Seat back + Positioning cushion

3. : Standard Wheelchair + Seat back + Positioning cushion + Belt

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.

Group Type: EXPERIMENTAL

Arm 2

Intervention Type: OTHER

Materials used for the course :

1. : Standard Wheelchair

2. : Standard Wheelchair + Seat back + Positioning cushion + Belt

3. : Standard Wheelchair + Seat back + Positioning cushion

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.

Group Type: EXPERIMENTAL

Arm 3

Intervention Type: OTHER

Materials used for the course :

1. : Standard Wheelchair + Seat back + Positioning cushion

2. : Standard Wheelchair + Seat back + Positioning cushion + Belt

3. : Standard Wheelchair

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.

Group Type: EXPERIMENTAL

Arm 4

Intervention Type: OTHER

Materials used for the course :

1. : Standard Wheelchair + Seat back + Positioning cushion

2. : Standard Wheelchair

3. : Standard Wheelchair + Seat back + Positioning cushion + Belt

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.

Group Type: EXPERIMENTAL

Arm 5

Intervention Type: OTHER

Materials used for the course :

1. : Standard Wheelchair + Seat back + Positioning cushion + Belt

2. : Standard Wheelchair

3. : Standard Wheelchair + Seat back + Positioning cushion

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.

Group Type: EXPERIMENTAL

Arm 6

Intervention Type: OTHER

Materials used for the course :

1. : Standard Wheelchair + Seat back + Positioning cushion + Belt

2. : Standard Wheelchair + Seat back + Positioning cushion

3. : Standard Wheelchair

Interventions

Arm 1

Materials used for the course :

1. : Standard Wheelchair

2. : Standard Wheelchair + Seat back + Positioning cushion

3. : Standard Wheelchair + Seat back + Positioning cushion + Belt

Intervention Type: OTHER

Arm 2

Materials used for the course :

1. : Standard Wheelchair

2. : Standard Wheelchair + Seat back + Positioning cushion + Belt

3. : Standard Wheelchair + Seat back + Positioning cushion

Intervention Type: OTHER

Arm 3

Materials used for the course :

1. : Standard Wheelchair + Seat back + Positioning cushion

2. : Standard Wheelchair + Seat back + Positioning cushion + Belt

3. : Standard Wheelchair

Intervention Type: OTHER

Arm 4

Materials used for the course :

1. : Standard Wheelchair + Seat back + Positioning cushion

2. : Standard Wheelchair

3. : Standard Wheelchair + Seat back + Positioning cushion + Belt

Intervention Type: OTHER

Arm 5

Materials used for the course :

1. : Standard Wheelchair + Seat back + Positioning cushion + Belt

2. : Standard Wheelchair

3. : Standard Wheelchair + Seat back + Positioning cushion

Intervention Type: OTHER

Arm 6

Materials used for the course :

1. : Standard Wheelchair + Seat back + Positioning cushion + Belt

2. : Standard Wheelchair + Seat back + Positioning cushion

3. : Standard Wheelchair

Intervention Type: OTHER

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…)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital NOVO

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadine Pellegrini

Role: PRINCIPAL_INVESTIGATOR

Groupement Hospitalier Intercommunal du Vexin

Locations

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, , France

Countries

France

Other Identifiers

GHIV0417

Identifier Type: -

Identifier Source: org_study_id