Spinal Cord InjuriesNCT06145789
The Use of Standing Powered Wheelchairs in Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to explore the experiences of standing powered wheelchair users with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- standing powered wheelchair evaluation
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2023to 18 Dec 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with spinal cord injury who were prescribed a standing powered wheelchair at a tertiary hospital
Who may be able to join
- Ages 18-70
- Post-spinal cord injury period > 1 year
Who cannot join
- Having cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara
About this study
Official title: The Use of Standing Powered Wheelchairs in Individuals With Spinal Cord Injury
The purpose of this study was to explore the experiences of standing powered wheelchair users with spinal cord injury.
Read the detailed description
There is limited research exploring the comfort, satisfaction, adverse effects, need for repair, and benefit in terms of secondary complications in standing powered wheelchair users with spinal cord injury.
The purpose of this study was to explore the experiences of standing powered wheelchair users with spinal cord injury.
- Conditions
- Spinal Cord Injuries
- Being tested
- standing powered wheelchair evaluation
- Keywords
- standing powered wheelchair, spinal cord injury, satisfaction, secondary complication
- Medical subject headings
- Spinal Cord Injuries, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standing powered wheelchair evaluationOther
standing powered wheelchair evaluation
| Study group | Role | What they receive |
|---|---|---|
| standing powered wheelchair | standing powered wheelchair evaluation Receives: Other: standing powered wheelchair evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheelchair satisfaction
The patients' level of satisfaction with the features of the standing powered wheelchair will be evaluated with a 5-point Likert scale (from (1) not satisfied at all to (5) very satisfied). Dissatisfaction reason will be noted.
Measured: through study completion, an average of one month
Wheelchair comfort
The patients' overall comfort level while using the standing powered wheelchair and the comfort level in some regions of the body (e.g. back, arms) in the standing position will be evaluated with a 5-point Likert scale (from (1) not satisfied at all to (5) very satisfied).
Measured: through study completion, an average of one month
Wheelchair repair
Participants will be asked whether the standing powered wheelchair needs repairs and the area repaired.
Measured: through study completion, an average of one month
Adverse and positive experiences
Participants will be asked about their adverse and positive experiences with the use of standing powered wheelchair
Measured: through study completion, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start27 Nov 2023
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Örücü Atar, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Merve Örücü Atar, MD, Principal investigator, Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145789
- Sponsor's protocol ID
- E1-23-4267
- Status last verified
- Dec 2023
- First submitted
- 17 Nov 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Standing Powered Wheelchairs in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06145789
- Acronym / sponsor ID
- E1-23-4267
- Conditions
- Spinal Cord Injuries
- Keywords
- standing powered wheelchair, spinal cord injury, satisfaction, secondary complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to explore the experiences of standing powered wheelchair users with spinal cord injury.
Detailed description
There is limited research exploring the comfort, satisfaction, adverse effects, need for repair, and benefit in terms of secondary complications in standing powered wheelchair users with spinal cord injury.
The purpose of this study was to explore the experiences of standing powered wheelchair users with spinal cord injury.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| standing powered wheelchair | – | Other: standing powered wheelchair evaluationstanding powered wheelchair evaluation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with spinal cord injury who were prescribed a standing powered wheelchair at a tertiary hospital
Key inclusion criteria (2 listed)
- Ages 18-70
- Post-spinal cord injury period > 1 year
Key exclusion criteria (1 listed)
- Having cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standing powered wheelchair evaluationstanding powered wheelchair evaluation | Other | standing powered wheelchair |
Primary outcome
Wheelchair satisfaction
Time frame: through study completion, an average of one month
The patients' level of satisfaction with the features of the standing powered wheelchair will be evaluated with a 5-point Likert scale (from (1) not satisfied at all to (5) very satisfied). Dissatisfaction reason will be noted.
Wheelchair comfort
Time frame: through study completion, an average of one month
The patients' overall comfort level while using the standing powered wheelchair and the comfort level in some regions of the body (e.g. back, arms) in the standing position will be evaluated with a 5-point Likert scale (from (1) not satisfied at all to (5) very satisfied).
Wheelchair repair
Time frame: through study completion, an average of one month
Participants will be asked whether the standing powered wheelchair needs repairs and the area repaired.
Adverse and positive experiences
Time frame: through study completion, an average of one month
Participants will be asked about their adverse and positive experiences with the use of standing powered wheelchair
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Örücü Atar, MD principal investigator
Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheelchair satisfaction (time frame: through study completion, an average of one month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2023.