- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02916784
Sit-to-stand in Spinal Cord Injury Patient
September 23, 2016 updated by: Sugalya Amatachaya, Khon Kaen University
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?
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
69
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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]
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Independent sit-to-stand test
Time Frame: 1 day
|
Ability to perform sit-to-stand independently
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower limb support during sit-to-stand test
Time Frame: 1 day
|
Percent of body-weight support during sit-to-stand performance
|
1 day
|
Timed up and go test
Time Frame: 1 day
|
Ability of dynamic balance control
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sugalya - Amatachaya, PhD, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (ACTUAL)
October 1, 2015
Study Completion (ACTUAL)
July 1, 2016
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
September 23, 2016
First Posted (ESTIMATE)
September 27, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
September 27, 2016
Last Update Submitted That Met QC Criteria
September 23, 2016
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 571H104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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