Clinical trial NCT03625193: Psychometric Properties of Sit-to-stand Test in Spinal Cord Injury
Official title: Appropriate Methods and Psychometric Properties of Sit-to-stand Test in Ambulatory Patients With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injuries
Keywords: Sit-to-stand test
Psychometric properties
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Ability to perform single and five times sit-to-stand test among 4 arm conditions
timeFrame: Change over 6 months
Secondary outcomes:
measure: 10-meter walk test
timeFrame: Change over 6 months
measure: Fall events
timeFrame: Over 6 months
measure: Global rating of change score (GRC score)
timeFrame: Change over 6 months
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Faculty of Associated Medical Science, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District
Study officials:
affiliation: School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.
name: Sugalya Amatachaya, PhD
role: PRINCIPAL_INVESTIGATOR
References: