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

• Conditions: Spinal Cord Injuries

• Registration Number: NCT03625193
• Lead Sponsor: Khon Kaen University

Brief Summary

1. 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)?

2. What are the factors associated with ability to perform STST in ambulatory individuals with SCI?

3. 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.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-01-10
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Primary Completion: 2018-12-20
• Last Update Submitted: 2019-03-10
• Last Update Posted: 2019-03-12
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
10-meter walk test	Change over 6 months	Change in walking speed during 6-month follow-up
Fall events	Over 6 months	Incidence of fall during 6-month follow-up
Global rating of change score (GRC score)	Change over 6 months	Level of change in subjects' independence in activities of daily life. The GRC score is divided into 15-point scale from "-7" (a very great deal worse) to "0" (about the same/ not change) to "7" (a very great deal better).

Trial Locations

Locations (1)

Faculty of Associated Medical Science, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District; 🇹🇭 Khon Kaen, Thailand