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Sit-to-stand With Feedback in SCI Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913911
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Sugalya Amatachaya, Khon Kaen University

Tracking Information
First Submitted Date  ICMJE September 22, 2016
First Posted Date  ICMJE September 26, 2016
Last Update Posted Date November 6, 2018
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
10MWT [ Time Frame: 2 weeks ]
walking speed test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sit-to-stand With Feedback in SCI Patients
Official Title  ICMJE The Provision of External Feedback During Sit-to-stand in Ambulatory Patients With Spinal Cord Injury
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Injuries, Spinal Cord
Intervention  ICMJE Other: feedback
Sit to stand training with external feedback
Study Arms  ICMJE
  • 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.
    Intervention: Other: 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.
    Intervention: Other: feedback
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2016)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ambulatory spinal cord injury patients

Exclusion Criteria:

  • Deformity of musculoskeletal system
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02913911
Other Study ID Numbers  ICMJE 2559A10303150
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sugalya Amatachaya, Khon Kaen University
Study Sponsor  ICMJE Khon Kaen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sugalya Amatachaya, Ph.D. School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand
PRS Account Khon Kaen University
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP