AzTrials
AzTrials

E07.796.980(wheelchair)NCT04751123

Does Prolonged Sitting Pressure Affect Sitting Pressure, Flexibility and Discomfort?

An observational study of E07.796.980 and G11.427.695, run by Necmettin Erbakan University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

ntroduction: Pressure sores and postural changes are observed in wheelchair users due to long sitting. Depending on this situation, the quality of life and activity participation level of these individuals decrease. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
E07.796.980, G11.427.695
How many people
15 participants
Where
No sites listed yet
Study dates
1 Mar 2021to 30 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Adult, Older adult

Study population: Patients who are being followed up in FTR or neurology Neurology clinics at Necmettin Erbakan University Meram Faculty of Medicine will be included in the study. In the G-Power analysis we conducted, the analysis was made based on comfort data in Cascioli's study (12). However, we think that the number of people to be included in the study is low in terms of objectivity of the data. For this reason, a preliminary study will be conducted during the study and the sample number will be determined.

Who may be able to join

  • Patients with multiple sclerosis, myopathies, amyotrophic lateral sclerosis, polio and medulla spinalis incision, Being 18 years of age or older, have used a wheelchair for at least three months being dependent on a wheelchair as a primary mobility (all day) or at certain times of the day -

Who cannot join

  • Individuals will be excluded if they have suffered pressure sores within the past year.
  • -

Trial locations and contacts

No sites are listed yet.

Sami Küçükşen, Prof. MD contact

+90 5054960742

samikucuksen@hotmail.com

About this study

Official title: Assessment of Wheelchair First and Last Seating Pressure and Posture and Wheelchair Satisfaction

ntroduction: Pressure sores and postural changes are observed in wheelchair users due to long sitting. Depending on this situation, the quality of life and activity participation level of these individuals decrease.

Method: This study will be conducted between March 1 and June 30, 2021 in Necmettin Erbakan University, Meram Faculty of Medicine, Physical Therapy and Rehabilitation Polyclinic. With the hamstring and trunk flexibility sit-lie test, six sensors placed on the sitting pressure sitting cushion, daily life activity FIM, skill assessment tests will be applied for manual and wheelchair users. Wheelchair Satisfaction CHART and quality of life World Health Organization Quality of Life (Whool ) will be evaluated with.

Read more

Application: Patients coming to the center spend 20 minutes on MAT. After resting, FIM will be evaluated with the sit-and-lie test. Afterwards, the patient will be put in a wheelchair. The initial sitting pressure will be taken as soon as you sit in the wheelchair. And at that time, CHART and WHOOL will be completed by asking the patient.

Conclusion: In the light of these evaluations, the change in initial sitting pressure and posture over time will be examined.

Read the detailed description

HH.3. Scope:

Which is about 12.29% of the population consists of disabled people in Turkey and the highest rate of disability It is known that physical disability (1). Having at least one wheelchair of approximately 75 million worldwide according to 2019 data plays a critical role in improving mobility (2). In fact, the wheelchair is one of the most widely used assistive technology tools to increase personal mobility and is a precondition for those with limited mobility to enjoy their human rights, live in dignity and become more productive members in their community. For many people, a well-designed and well-equipped wheelchair can be the right step for social inclusion (3). More than half of wheelchair users need assistance with using their wheelchairs and daily living activities (4). The literature investigating the factors affecting wheelchair use mainly consists of variables related to the environment and physical characteristics of wheelchair users (4). Correct selection and configuration of wheelchairs can increase mobility, effectiveness and participation (5).

While sitting comfort is associated with softness and support, lack of support, unbalanced pressure distribution, biomechanics and fatigue factors are associated with sitting discomfort. Anatomical factors can cause characteristic tissue loads that appear to be associated with tissue damage, discomfort, or axillary posture or movement modifications. Following excessive or prolonged tissue loading, cell death may lead to the development of superficial or deep compression wounds (6). A superficial pressure sore first affects the skin layers near the epidermal tissue and is typically associated with damaging friction and shear forces with the presence of moisture and heat (7). Deep compression sores typically begin with the deformation of deep muscle and fat tissues beneath the ischial tuberocytes in the sitting position (8). Although the etiology of pressure sores is multifactorial (9), continuous pressure at the user seat interface is considered the most important factor (10,11). Therefore, wheelchair features are very important for posture and pressure sores. In our study, wheelchair features will be examined and these features will be compared with patient satisfaction. In addition, wheelchair characteristics and patient satisfaction in different patient groups (such as spinal cord injury, Multiple Sclerosis, Cerebrovascular Incident (stroke)) will also be discussed.

Hypotheses Ho: There is no difference between initial sitting pressure and posture in wheelchair users and sitting pressure and posture after 2 and 3 hours.

H1: There is a difference between the initial sitting pressure and posture in wheelchair users and the sitting pressure and posture after 2 and 3 hours.

H2: There is a difference between the initial sitting pressure and posture and the sitting pressure and posture after 2 and 3 hours in different patient groups.

H.4. Method: Individuals Patients who are being followed up in FTR or neurology Neurology clinics at Necmettin Erbakan University Meram Faculty of Medicine will be included in the study. In the G-Power analysis we conducted, Cascioli's study was based on comfort (12). However, we think that the number of people to be included in the study is low in terms of objectivity of the data. For this reason, a preliminary study will be conducted during the study and the sample number will be confirmed.

  1. Physical characteristics and history taking: Patients will be asked in detail about age, height, weight, disease diagnosis and duration, and wheelchair characteristics. Inclusion criteria were:
  2. Patients with multiple sclerosis, myopathies, amyotrophic lateral sclerosis, polio and medulla spinalis incision,
  3. Being 18 years of age or older,
  4. have used a wheelchair for at least three months,
  5. being dependent on a wheelchair (all day) or at certain times of the day as the primary means of movement, Individuals will be excluded if they have suffered pressure sores within the last year.
  6. Evaluations After taking the patient's history, the person was taken to MAT bed for 20 minutes. will be provided to rest. 20 minutes At the end, the patient who passes to the wheelchair will be asked to evaluate the comfort and discomfort they perceived after the first contact in the chair as 0 (none) -10 (very bad). Grading will be asked to evaluate the discomfort in the head, neck, back, waist, hips and legs, not the general sense of comfort. Meanwhile, pressure and posture will be evaluated.
  • Route-Reach test: This test is used to evaluate hamstring and trunk flexion flexibility. The subject will be asked to sit on the test table with both knees in extension on a firm surface and reach out with his hands and feet without bending the knees. The distance between the fingers and the tip of the test table is measured with a ruler
Keywords
wheelchair, seating pressure, posture, life quality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of Wheelchair First-Last Seating Pressure and Posture and Wheelchair Satisfaction

    All af study

    Measured: 45 minutes

  2. Sit-Reach test: Pressure Rating: It will be evaluated in kilograms

    the value will be recorded in centimeters (cm).

    Measured: 2 two minutes

  3. Pressure Rating

    It will be evaluated in kilograms

    Measured: 3 minutes

Secondary outcomes (4)
  1. Evaluation of basic daily living activities (FIM)

    The total FIM score can range from 18-126.

    Measured: 10 minutes

  2. Craig Handicap Assessment and Reporting Technique (CHART)

    Has a scale score ranging from 0 to 100

    Measured: 10 minutes

  3. Wheelchair Skills Test (WST) for manual wheelchair users

    Total WST Capacity Score = total of individual skill points / ([number of possible skills - number of NP points - number of TE points] x 3) X 100%

    Measured: 15 minutes

  4. World Health Organization Quality of Life Scale (WHOQOL):

    WHOQOL-BREF, unlike the long scale, consists of 4 domains. They do not have separate sections. This scale also has no total score. Each section and area scores a maximum of 20 points or 100 points

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2021
  2. Study start1 Mar 2021 (estimated)
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion30 Aug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04751123
Sponsor's protocol ID
NecmettinNEU
Acronym
(wheelchair)
Status last verified
Feb 2021
First submitted
3 Feb 2021
Last updated
11 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: When the research is published, I will share my data over Mendeley data sharing.

Publications

  • Ferrarin M, Andreoni G, Pedotti A. Comparative biomechanical evaluation of different wheelchair seat cushions. J Rehabil Res Dev. 2000 May-Jun;37(3):315-24.

    PubMed 10917263
  • Linder-Ganz E, Shabshin N, Itzchak Y, Gefen A. Assessment of mechanical conditions in sub-dermal tissues during sitting: a combined experimental-MRI and finite element approach. J Biomech. 2007;40(7):1443-54. doi: 10.1016/j.jbiomech.2006.06.020. Epub 2006 Aug 21.

    PubMed 16920122
  • Crenshaw RP, Vistnes LM. A decade of pressure sore research: 1977-1987. J Rehabil Res Dev. 1989 Winter;26(1):63-74. No abstract available.

    PubMed 2645399
  • Krause JS, Vines CL, Farley TL, Sniezek J, Coker J. An exploratory study of pressure ulcers after spinal cord injury: relationship to protective behaviors and risk factors. Arch Phys Med Rehabil. 2001 Jan;82(1):107-13. doi: 10.1053/apmr.2001.18050.

    PubMed 11239295

Questions about this trial

What is this clinical trial studying?

An observational study of E07.796.980 and G11.427.695, run by Necmettin Erbakan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact FATMA ERDEO, Phd (+905054431778, fatmacobanerdeo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Wheelchair First-Last Seating Pressure and Posture and Wheelchair Satisfaction (time frame: 45 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04751123, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in