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

Hôpital NOVO

Status: Completed

Conditions: Hemiplegia And/or Hemiparesis Following Stroke

Treatments: Other: Arm 5; Other: Arm 3; Other: Arm 2; Other: Arm 1; Other: Arm 4; Other: Arm 6

Study type: Interventional

Funder types: Other

Identifiers

NCT04268641

GHIV0417

Details and patient eligibility

About

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

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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...)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Use of positioning equipment order 1

Experimental group

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.

Treatment:

Other: Arm 1

Use of positioning equipment order 2

Experimental group

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.

Treatment:

Other: Arm 2

Use of positioning equipment order 3

Experimental group

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.

Treatment:

Other: Arm 3

Use of positioning equipment order 4

Experimental group

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.

Treatment:

Other: Arm 4

Use of positioning equipment order 5

Experimental group

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.

Treatment:

Other: Arm 5

Use of positioning equipment order 6

Experimental group

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.

Treatment:

Other: Arm 6