Spinal Cord InjuriesNCT06657742
Validity and Reliability of SCIM-SR
An observational study of Spinal Cord Injuries, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To determine the validity and reliability of SCIM-SR, patients will fill out SCIM 3 and SR. 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?
- SCIM-SR
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2023to 16 Jul 2024
- 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
- Adult, Older adult
Study population: -SCI patients between the ages of 18-70 and at least 1 month after their injury
Who may be able to join
- SCI >1 month
- 18-70 years
- agree to participate
- give written consent
Who cannot join
- not read Turkish,
- not write Turkish,
- cognitive problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cansın Medin Ceylan
Istanbul, None Selected, 34147
About this study
Official title: Validity and Reliability of the Turkish Version of the Spinal Cord Independence Measure Self-Report
To determine the validity and reliability of SCIM-SR, patients will fill out SCIM 3 and SR.
Read the detailed description
To determine the validity and reliability of SCIM-SR, patients will fill out SCIM 3 and SR. scım-sr Turkish form has been created. Patients with spinal cord injuries who applied to our physical therapy clinic filled out the form twice.
- Conditions
- Spinal Cord Injuries
- Being tested
- SCIM-SR
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCIM-SROther
SCIM-SR was a self-reported scale that evaluated the independence of patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
SCIM-SR
scım-sr was a self-reported scale that evaluated the independence of patients.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start16 Oct 2023
- Primary completion16 Jun 2024
- Study completion16 Jul 2024
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yelda Soluk Özdemir, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657742
- Sponsor's protocol ID
- 2023/385
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Spinal Cord Independence Measure Self-Report
- ClinicalTrials.gov ID
- NCT06657742
- Acronym / sponsor ID
- 2023/385
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 16 Jun 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 24 Oct 2024 (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.
To determine the validity and reliability of SCIM-SR, patients will fill out SCIM 3 and SR.
Detailed description
To determine the validity and reliability of SCIM-SR, patients will fill out SCIM 3 and SR. scım-sr Turkish form has been created. Patients with spinal cord injuries who applied to our physical therapy clinic filled out the form twice.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- -SCI patients between the ages of 18-70 and at least 1 month after their injury
Key inclusion criteria (4 listed)
- SCI >1 month
- 18-70 years
- agree to participate
- give written consent
Key exclusion criteria (3 listed)
- not read Turkish,
- not write Turkish,
- cognitive problems
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 |
|---|---|---|
| SCIM-SRSCIM-SR was a self-reported scale that evaluated the independence of patients. | Other | – |
Primary outcome
SCIM-SR
Time frame: baseline
scım-sr was a self-reported scale that evaluated the independence of patients.
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 24 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Istanbul Physical Medicine Rehabilitation Training 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 4 inclusion and 3 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 24 Oct 2024. 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?
SCIM-SR (time frame: baseline). 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 24 Oct 2024.