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

Study Overview
=================
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.

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

Conditions
-----------------
Spinal Cord Injuries

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ambulatory patients with SCI<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sit-to-stand test, Psychometric properties