Psychometric Properties of Sit-to-stand Test in Spinal Co... | NCT03625193

Studies
Psychometric Properties of Sit-to-stand Test in Spinal Cord Injury

NCT03625193

Sponsor

Khon Kaen University

Status

Unknown status

Last Update Posted

Mar 12, 2019Actual

Enrollment

182Estimated

Phase

Not provided

Conditions

Spinal Cord Injuries

Interventions

Not provided

Countries

Thailand

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Dec 20, 2018Actual

Completion Date

Aug 31, 2019Estimated

First Submitted Date

Jan 10, 2018

First Submission Date that Met QC Criteria

Aug 7, 2018

First Posted Date

Aug 10, 2018Actual

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

Mar 10, 2019

Last Update Posted Date

Mar 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Do different arm placements (including arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) influence outcomes of sit-to-stand test (STST) in ambulatory individuals with spinal cord injury (SCI)?
What are the factors associated with ability to perform STST in ambulatory individuals with SCI?
Are the single-time sit-to-stand test (STSST) and five-time sit-to-stand test (FTSST) reliable, valid and responsive to determine functional alteration in ambulatory individuals with SCI?

Detailed Description

To cross-sectionally compare characteristics (duration and amount of lower limb loading) of STS movements among 4 arm placement conditions (arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) in ambulatory patients with SCI.
To investigate reliability (inter-rater, intra-rater, and test-retest), standard error of measurement and minimal detectable changes of the STSST and FTSST in ambulatory patients with SCI.
To investigate concurrent validity and factors associated with ability of the STSST and FTSST in ambulatory patients with SCI.
To investigate the ability of the STSST and FTSST to predict the risk of falls over 1, 3 and 6 months in ambulatory patients with SCI.
To investigate internal and external responsiveness of the STSST and FTSST to detect changes on walking ability over 1, 3 and 6 months in ambulatory patients with SCI.
To estimate the minimal clinically important difference or clinical significance of the FTSST in ambulatory patients with SCI.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

182Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ambulatory patients with SCI		Age at least 18 years Body mass index (BMI) between 18.5 - 29.9 kg/m2 Having an incomplete SCI from traumatic or non-traumatic causes Ability of independent standing up from a chair with or without hand support Ability of independent walking with or without walking device over at least 10 meters continuously. Ability to follow commands used in the studies

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ability to perform single and five times sit-to-stand test among 4 arm conditions	Ability to execute a single time sit-to-stand and time used for five times sit-to-stand	Change over 6 months

Secondary Outcomes

Measure	Description	Time Frame
10-meter walk test	Change in walking speed during 6-month follow-up	Change over 6 months
Fall events	Incidence of fall during 6-month follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body mass index (BMI) between 18.5 - 29.9 kg/m2
Having an incomplete SCI from traumatic or non-traumatic causes
Ability of independent standing up from a chair with or without hand support
Ability of independent walking with or without walking device over at least 10 meters continuously.
Ability to follow commands used in the studies

Exclusion Criteria:

Any ambulatory individuals with incomplete SCI who present signs and symptoms that might affect ability to perform STST will be excluded from the study such as

Pain in the muscles or joints with an intensity of pain more than 5 out of 10 on a numeric rating scale (NRS)
Joint deformities that affect mobility
Other neurological disorders such as having brain lesions
Unstable medical conditions
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study is conducted in patients with spinal cord injury who able to sit-to-stand independently with or without hand support from the Srinagarind hospital and communities in the Northeast areas of Thailand.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lalita Khuna, PhD student	Contact	+66637391999		lalitakhuna@gmail.com

Overall Officials

Name	Affiliation	Role
Sugalya Amatachaya, PhD	School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Associated Medical Science, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District	Recruiting	Khon Kaen		40002	Thailand

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