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

Appropriate Methods and Psychometric Properties of Sit-to-stand Test in Ambulatory Patients With Spinal Cord Injury

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?

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injuries

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 Type: Observational
• Enrollment (Anticipated): 182

Contacts and Locations

• Study Contact: Name: Lalita Khuna, PhD student; Phone Number: +66637391999; Email: lalitakhuna@gmail.com

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Recruiting
    • Faculty of Associated Medical Science, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District
    • Contact: Lalita Khuna; Phone Number: +66637391999; Email: lalitakhuna@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	Over 6 months
Global rating of change score (GRC score)	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).	Change over 6 months

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Investigators: Principal Investigator: Sugalya Amatachaya, PhD, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): December 20, 2018
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 10, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Sit-to-stand test; Psychometric properties
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: PHD02232558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No