Validity and Reliability of SCIM-SR | NCT06657742

Studies
Validity and Reliability of SCIM-SR

NCT06657742

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Status

Completed

Last Update Posted

Oct 24, 2024Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Spinal Cord Injuries

Interventions

SCIM-SR

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 16, 2023Actual

Primary Completion Date

Jun 16, 2024Actual

Completion Date

Jul 16, 2024Actual

First Submitted Date

Oct 22, 2024

First Submission Date that Met QC Criteria

Oct 23, 2024

First Posted Date

Oct 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2024

Last Update Posted Date

Oct 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yelda Soluk Özdemir, Principle investigator, Istanbul Physical Medicine Rehabilitation Training and Research HospitalPrincipal Investigator

Lead Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SCIM-SR	Other	SCIM-SR was a self-reported scale that evaluated the independence of patients.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SCIM-SR	scım-sr was a self-reported scale that evaluated the independence of patients.	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

SCI >1 month
18-70 years
agree to participate
give written consent

Exclusion Criteria:

not read Turkish,
not write Turkish,
cognitive problems

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

-SCI patients between the ages of 18-70 and at least 1 month after their injury

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cansın Medin Ceylan		Istanbul	None Selected	34147	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided