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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03625193
• Other study ID #: PHD02232558
• Status: Recruiting
• Start date: October 1, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: August 2018
• Source: Khon Kaen University
• Contact: Lalita Khuna, PhD student
• Phone: +66637391999
• Email: lalitakhuna[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: August 31, 2019
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
Thailand	Faculty of Associated Medical Science, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10-meter walk test	Change in walking speed during 6-month follow-up	Change over 6 months
Secondary	Fall events	Incidence of fall during 6-month follow-up	Over 6 months
Secondary	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