Viewing Study NCT03321357


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Study NCT ID: NCT03321357
Status: COMPLETED
Last Update Posted: 2018-07-13
First Post: 2017-10-23
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Retest-reliability and At-home-assessment Feasibility of the 5R-STS
Sponsor: Bergman Clinics
Organization:

Study Overview

Official Title: Test-retest-reliability and At-home-assessment Feasibility of the Five-repetition Sit-to-stand Test (5R-STS)
Status: COMPLETED
Status Verified Date: 2018-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: 5RSTS-2
Brief Summary: The five-repetition sit-to-stand test has been validated and is used primarily in pulmonary medicine and cardiology, and has recently been shown to be a useful tool for the objective assessment of functional impairment in patients with degenerative diseases of the lumbar spine.

The goal of this study is to assess the possibility of supervised and unsupervised at-home-assessment. Validation of at-home-assessment would allow the 5R-STS to be easily used as a follow-up tool in clinical trials, for example.
Detailed Description: Patients will perform three 5R-STS measurements:

1. During outpatient clinics, time measured by the physician
2. At home, time measured by partner/family
3. At home, and assessed by producing a video recording of the 5R-STS performance that is subsequently sent and analyzed (time measured digitally)

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: