Spinal Cord InjuriesNCT03625193
Psychometric Properties of Sit-to-stand Test in Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by Khon Kaen University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 182 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2017to 31 Aug 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Associated Medical Science, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District
Khon Kaen, 40002
Lalita Khuna, +66637391999, lalitakhuna@gmail.com
About this study
Official title: Appropriate Methods and Psychometric Properties of Sit-to-stand Test in Ambulatory Patients With Spinal Cord Injury
- 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?
Read the 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.
- Conditions
- Spinal Cord Injuries
- Keywords
- Sit-to-stand test, Psychometric properties
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change over 6 months
Secondary outcomes (3)
10-meter walk test
Change in walking speed during 6-month follow-up
Measured: Change over 6 months
Fall events
Incidence of fall during 6-month follow-up
Measured: 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).
Measured: Change over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Oct 2017
- Primary completion20 Dec 2018
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sugalya Amatachaya, Khon Kaen University
- Investigators
- Sugalya Amatachaya, PhD, Principal investigator, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625193
- Sponsor's protocol ID
- PHD02232558
- Status last verified
- Aug 2018
- First submitted
- 10 Jan 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Methods and Psychometric Properties of Sit-to-stand Test in Ambulatory Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03625193
- Acronym / sponsor ID
- PHD02232558
- Conditions
- Spinal Cord Injuries
- Keywords
- Sit-to-stand test, Psychometric properties
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ability to perform single and five times sit-to-stand test among 4 arm conditions
Time frame: Change over 6 months
Ability to execute a single time sit-to-stand and time used for five times sit-to-stand
3 secondary outcomes
10-meter walk test
Time frame: Change over 6 months
Fall events
Time frame: Over 6 months
Global rating of change score (GRC score)
Time frame: Change over 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sugalya Amatachaya, PhD principal investigator
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lalita Khuna, PhD student (+66637391999, lalitakhuna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to perform single and five times sit-to-stand test among 4 arm conditions (time frame: Change over 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.