Injuries, Spinal CordNCT02916784
Sit-to-stand in Spinal Cord Injury Patient
An observational study of Injuries, Spinal Cord, run by Khon Kaen University.
Trial summary
1. Were there differences in functional ability between ambulatory individuals with SCI who passed and failed the independent sit-to-stand (iSTS) task? 2. Did the ability of iSTS relate to ability of walking as determined using a type of AAD used? 3. What were factors associated with the ability of iSTS? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injuries, Spinal Cord
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2016
- 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 subjects with incomplete spinal cord injury (iSCI) who are able to walk independently with or without an ambulatory assistive device (AAD) from the Srinagarind hospital, KhonKaen University, Thailand.
Who may be able to join
- Ambulatory patients with iSCI from both non-traumatic and traumatic causes
- Aged at least 18 years
- Who are able to walk independently with or without AADs at least 15 meters continuously [FIM locomotor (FIM-L) scores = 5 to 7]
Who cannot join
- Any patients with conditions that might affect ambulatory ability; such as brain function disorders, visual deficits, musculoskeletal pain (VAS > 5), deformity of the musculoskeletal system, unable to follow a command of the tests, unstable medical conditions.
About this study
Official title: Relationship Between Ability of Sit-to-stand and Types of Walking Device Used in Ambulatory Patients With Spinal Cord Injury
- Were there differences in functional ability between ambulatory individuals with SCI who passed and failed the independent sit-to-stand (iSTS) task?
- Did the ability of iSTS relate to ability of walking as determined using a type of AAD used?
- What were factors associated with the ability of iSTS?
Read the detailed description
- To evaluate the proportion and compare functional abilities between subjects who passed and failed the independent sit-to-stand (iSTS) task.
- To assess the relationship between ability of iSTS and types of AAD used.
- To investigate factors associated with the ability of iSTS.
- Conditions
- Injuries, Spinal Cord
- Keywords
- Sit-to-stand, Walking devices
- 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 |
|---|---|---|
| Sit-to-stand: Pass | The subjects seated on a standard armless chair with their back upright at 90 degrees against the backrest of the chair, feet placement on the floor with the heels at 10 cm behind the knees and their arms on their sides. Then they were instructed to stand up from the chair without using the arms. The ability was recorded as 'pass' if the subjects could safely rise from the chair without using their arms and with no more than contact guarding assist. | |
| Sit-to-stand: Fail | The subjects seated on a standard armless chair with their back upright at 90 degrees against the backrest of the chair, feet placement on the floor with the heels at 10 cm behind the knees and their arms on their sides. Then they were instructed to stand up from the chair without using the arms. The ability was recorded as 'fail' if the subjects could not rise from the chair without using their arms and/or with more than contact guarding assist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent sit-to-stand test
Ability to perform sit-to-stand independently
Measured: 1 day
Secondary outcomes (2)
Lower limb support during sit-to-stand test
Percent of body-weight support during sit-to-stand performance
Measured: 1 day
Timed up and go test
Ability of dynamic balance control
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injuries, Spinal CordStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
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
- NCT02916784
- Sponsor's protocol ID
- 571H104
- Status last verified
- Nov 2015
- First submitted
- 22 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Ability of Sit-to-stand and Types of Walking Device Used in Ambulatory Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02916784
- Acronym / sponsor ID
- 571H104
- Conditions
- Injuries, Spinal Cord
- Keywords
- Sit-to-stand, Walking devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Sep 2016 (estimated)
- 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.
- Were there differences in functional ability between ambulatory individuals with SCI who passed and failed the independent sit-to-stand (iSTS) task?
- Did the ability of iSTS relate to ability of walking as determined using a type of AAD used?
- What were factors associated with the ability of iSTS?
Detailed description
- To evaluate the proportion and compare functional abilities between subjects who passed and failed the independent sit-to-stand (iSTS) task.
- To assess the relationship between ability of iSTS and types of AAD used.
- To investigate factors associated with the ability of iSTS.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sit-to-stand: Pass | – | –The subjects seated on a standard armless chair with their back upright at 90 degrees against the backrest of the chair, feet placement on the floor with the heels at 10 cm behind the knees and their arms on their sides. Then they were instructed to stand up from the chair without using the arms. The ability was recorded as 'pass' if the subjects could safely rise from the chair without using their arms and with no more than contact guarding assist. |
| Sit-to-stand: Fail | – | –The subjects seated on a standard armless chair with their back upright at 90 degrees against the backrest of the chair, feet placement on the floor with the heels at 10 cm behind the knees and their arms on their sides. Then they were instructed to stand up from the chair without using the arms. The ability was recorded as 'fail' if the subjects could not rise from the chair without using their arms and/or with more than contact guarding assist. |
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 subjects with incomplete spinal cord injury (iSCI) who are able to walk independently with or without an ambulatory assistive device (AAD) from the Srinagarind hospital, KhonKaen University, Thailand.
Key inclusion criteria (3 listed)
- Ambulatory patients with iSCI from both non-traumatic and traumatic causes
- Aged at least 18 years
- Who are able to walk independently with or without AADs at least 15 meters continuously [FIM locomotor (FIM-L) scores = 5 to 7]
Key exclusion criteria (1 listed)
- Any patients with conditions that might affect ambulatory ability; such as brain function disorders, visual deficits, musculoskeletal pain (VAS > 5), deformity of the musculoskeletal system, unable to follow a command of the tests, 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
Independent sit-to-stand test
Time frame: 1 day
Ability to perform sit-to-stand independently
2 secondary outcomes
Lower limb support during sit-to-stand test
Time frame: 1 day
Timed up and go test
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Injuries, Spinal Cord, run by Khon Kaen University.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independent sit-to-stand test (time frame: 1 day). 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 27 Sep 2016.