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Completed

NCT Number: NCT04268641

Evaluation of Positioning Protocols on a Wheelchair in Hemiplegic Patients

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupement Hospitalier Intercommunal du Vexin, Aincourt, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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…)

Treatment and study plan

Arm 1

Other

Materials used for the course :

  • : Standard Wheelchair
  • : Standard Wheelchair + Seat back + Positioning cushion
  • : Standard Wheelchair + Seat back + Positioning cushion + Belt

Arm 2

Other

Materials used for the course :

  • : Standard Wheelchair
  • : Standard Wheelchair + Seat back + Positioning cushion + Belt
  • : Standard Wheelchair + Seat back + Positioning cushion

Arm 3

Other

Materials used for the course :

  • : Standard Wheelchair + Seat back + Positioning cushion
  • : Standard Wheelchair + Seat back + Positioning cushion + Belt
  • : Standard Wheelchair

Arm 4

Other

Materials used for the course :

  • : Standard Wheelchair + Seat back + Positioning cushion
  • : Standard Wheelchair
  • : Standard Wheelchair + Seat back + Positioning cushion + Belt

Arm 5

Other

Materials used for the course :

  • : Standard Wheelchair + Seat back + Positioning cushion + Belt
  • : Standard Wheelchair
  • : Standard Wheelchair + Seat back + Positioning cushion

Arm 6

Other

Materials used for the course :

  • : Standard Wheelchair + Seat back + Positioning cushion + Belt
  • : Standard Wheelchair + Seat back + Positioning cushion
  • : Standard Wheelchair

Primary outcomes

  1. Degree of pelvic posterior tilt

    Time frame: Immediately after the end of the procedure, an average of 1 day

    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 outcomes

  1. Variation of Degree of pelvic posterior tilt

    Time frame: Baseline and immediately after the end of the procedure, an average of 1 day

    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)

  2. Variation of degree of lateral inclination of the torso

    Time frame: Baseline and immediately after the end of the procedure, an average of 1 day

    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)

  3. Variation of the degree of Pelvis obliquity

    Time frame: Baseline and immediately after the end of the procedure, an average of 1 day

    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)

  4. Degree of lateral inclination of the torso

    Time frame: Immediately after the end of the procedure, an average of 1 day

    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)

  5. Degree of Pelvis obliquity

    Time frame: Immediately after the end of the procedure, an average of 1 day

    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)

  6. Measure of patient's satisfaction

    Time frame: Immediately after the end of the procedure, an average of 1 day

    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

  7. Ability to achieve the whole course

    Time frame: Immediately after the end of the procedure, an average of 1 day

    Binary criteria (Yes / No)

  8. Adverse event collect

    Time frame: Immediately after the end of the procedure, an average of 1 day

    Total number of adverse event

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

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

Acronym: POSIT-HEMI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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