Injuries, Spinal CordNCT02913911
Sit-to-stand With Feedback in SCI Patients
A study testing feedback in people with Injuries, Spinal Cord, run by Khon Kaen University.
Trial summary
Does the utility of external feedback in terms of goal-directed LLL approach during STS training immediately improve functional ability relating to walking in ambulatory patients with SCI? Does the utility of LLL feedback improve functional ability relating to walking in ambulatory patients with SCI after 2-week… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Injuries, Spinal Cord
- What is being tested?
- feedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jul 2018
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory spinal cord injury patients
Who cannot join
- Deformity of musculoskeletal system
About this study
Official title: The Provision of External Feedback During Sit-to-stand in Ambulatory Patients With Spinal Cord Injury
- Does the utility of external feedback in terms of goal-directed LLL approach during STS training immediately improve functional ability relating to walking in ambulatory patients with SCI?
- Does the utility of LLL feedback improve functional ability relating to walking in ambulatory patients with SCI after 2-week training?
Read the detailed description
- To compare immediate effects of STS training with and without LLL feedback on functional ability relating to walking in ambulatory patients with SCI
- To compare 2 weeks effects of STS training with and without LLL feedback on functional ability relating to walking in ambulatory patients with SCI.
- Conditions
- Injuries, Spinal Cord
- Being tested
- feedback
- Keywords
- feedback
- 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.
feedbackOther
Sit to stand training with external feedback
| Study group | Role | What they receive |
|---|---|---|
| Feedback | Experimental | Subjects will be trained using the sit-to-stand weight-taking machine. Prior to the training, subjects sit in a standard sitting position. Then they will be instructed to take most of their body-weight onto the legs while they standing up where the light bars will be gradually lightened from the red, yellow and green zones according to the level of LLL. Then they stand up, hold a standing position for 3-5 seconds and sit-down with always maximize their body-weight onto their legs during performing the task in which the green zone will always be lightened. Receives: Other: feedback |
| No feedback | Sham comparator | Subjects will be trained using the same instruction and protocol as the experimental group, but without the provision of external feedback. Receives: Other: feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
10MWT
walking speed test
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionAug 2017
- Study completionJul 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 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, Ph.D., Principal investigator, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913911
- Sponsor's protocol ID
- 2559A10303150
- Status last verified
- Nov 2015
- First submitted
- 22 Sep 2016
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Provision of External Feedback During Sit-to-stand in Ambulatory Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02913911
- Acronym / sponsor ID
- 2559A10303150
- Conditions
- Injuries, Spinal Cord
- Keywords
- feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 26 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.
- Does the utility of external feedback in terms of goal-directed LLL approach during STS training immediately improve functional ability relating to walking in ambulatory patients with SCI?
- Does the utility of LLL feedback improve functional ability relating to walking in ambulatory patients with SCI after 2-week training?
Detailed description
- To compare immediate effects of STS training with and without LLL feedback on functional ability relating to walking in ambulatory patients with SCI
- To compare 2 weeks effects of STS training with and without LLL feedback on functional ability relating to walking in ambulatory patients with SCI.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback | Experimental | Other: feedbackSubjects will be trained using the sit-to-stand weight-taking machine. Prior to the training, subjects sit in a standard sitting position. Then they will be instructed to take most of their body-weight onto the legs while they standing up where the light bars will be gradually lightened from the red, yellow and green zones according to the level of LLL. Then they stand up, hold a standing position for 3-5 seconds and sit-down with always maximize their body-weight onto their legs during performing the task in which the green zone will always be lightened. |
| No feedback | Sham comparator | Other: feedbackSubjects will be trained using the same instruction and protocol as the experimental group, but without the provision of external feedback. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ambulatory spinal cord injury patients
Key exclusion criteria (1 listed)
- Deformity of musculoskeletal system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| feedbackSit to stand training with external feedback | Other | Feedback, No feedback |
Primary outcome
10MWT
Time frame: 2 weeks
walking speed test
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 6 Nov 2018.
- 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, Ph.D. 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?
A study testing feedback in people with 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 1 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 6 Nov 2018. 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. Some participants in this study may receive a placebo. 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?
10MWT (time frame: 2 weeks). 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 6 Nov 2018.