- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02913911
Sit-to-stand With Feedback in SCI Patients
November 3, 2018 updated by: Sugalya Amatachaya, Khon Kaen University
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?
Study Overview
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ambulatory spinal cord injury patients
Exclusion Criteria:
- Deformity of musculoskeletal system
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Feedback
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.
|
Sit to stand training with external feedback
|
Sham Comparator: No feedback
Subjects will be trained using the same instruction and protocol as the experimental group, but without the provision of external feedback.
|
Sit to stand training with external feedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10MWT
Time Frame: 2 weeks
|
walking speed test
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sugalya Amatachaya, Ph.D., 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 (Actual)
November 1, 2015
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
September 22, 2016
First Posted (Estimate)
September 26, 2016
Study Record Updates
Last Update Posted (Actual)
November 6, 2018
Last Update Submitted That Met QC Criteria
November 3, 2018
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2559A10303150
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.
Clinical Trials on Injuries, Spinal Cord
-
Khon Kaen UniversityUnknownInjuries, Spinal Cord
-
Universidade do Vale do ParaíbaCompletedInjuries, Spinal Cord
-
InVivo TherapeuticsTerminated
-
Ekso BionicsBurke Medical Research InstituteCompletedInjuries, Spinal CordUnited States
-
ReWalk Robotics, Inc.Unknown
-
Shepherd Center, Atlanta GACompletedInjuries, Spinal Cord
-
Wroclaw Medical UniversityInstitute of Immunology and Experimental Therapy of the Polish Academy of... and other collaboratorsUnknownComplete Spinal Cord InjuriesPoland
-
University of MiamiViewray Inc.Not yet recruitingSpinal Cord Compression | Metastatic Epidural Spinal Cord CompressionUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingMetastatic Epidural Spinal Cord CompressionUnited States
Clinical Trials on feedback
-
University of MichiganEnrolling by invitationDepression | Anxiety | Sleep Disturbance | AddictionUnited States
-
University Hospital, CaenUnknown
-
Northwestern UniversityCompletedAutism Spectrum Disorder | AutismUnited States
-
University of North Carolina, Chapel HillNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedAphasia | Cerebrovascular Accident | Apraxia of SpeechUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH); VA Connecticut Healthcare SystemTerminatedPost-Traumatic Stress DisorderUnited States
-
Albert Einstein College of MedicineNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Duke UniversityTerminatedFeeding Behavior | Diet Habit | Behavior, HealthUnited States
-
KEMRI-Wellcome Trust Collaborative Research ProgramCompleted