- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02914041
Kyphotic Measure Using Distance From the Wall
August 18, 2017 updated by: Sugalya Amatachaya, Khon Kaen University
Kyphotic Measure Using Distance From the Wall: Reliability, Validity and Distance From the Wall to Indicate Risk for Spinal Fracture
Are the KypDisT and conventional C7WD are practical, valid, reliable, and effectiveness of the tools to discriminate the functional ability impairments relating to kyphosis when compare with gold standard (Cobb's method), and compare among physical therapy, VHS and caregiver?
Study Overview
Status
Unknown
Conditions
Detailed Description
- To further develop an innovation to measure kyphosis using distance from the wall, a Kyphosis wall distance tool (KypDisT).
investigate validity of the measurements in terms of 2.1 Concurrent validity of conventional C7WD and KypDisT as compared to a gold standard (Cobb's method).
2.2 Discriminative ability of conventional C7WD and KypDisT on functional abilities in elderly with different severity of kyphosis.
- To investigate the reliability of the measurements in terms of 3.1 Test-retest reliability of conventional C7WD and KypDisT. 3.2 Reliability of conventional C7WD and KypDisT comparing among physical therapy, VHS and caregiver.
- To explore the distance to indicate risk of spinal fracture to indicate a risk of spinal fracture.
Study Type
Observational
Enrollment (Anticipated)
96
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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Elderly who live community-dwelling with different degrees of kyphosis, aged at least 60 years with a body mass index between 18.5-29.9
kg/m2 and OWD >0 cm.
(Wongsa et al., 2012).
However, elderly are excluded if they present signs and symptoms that may affect participation in the study, i.e. unstable medical condition, pain or inflammation in the joints of the lower extremity (pain scale > 5), having sequelae of neurological deficits, and unable to understand and follow a simple command used in the study.
Description
Inclusion Criteria:
- Community-dwelling elderly with different degrees of kyphosis,
- Aged at least 60 years
- Body mass index between 18.5-29.9 kg/m2
- OWD >0 cm.
Exclusion Criteria:
- Present signs and symptoms that may affect participation in the study, i.e. unstable medical condition, pain or inflammation in the joints of the lower extremity (pain scale > 5), having sequelae of neurological deficits
- Unable to understand and follow a simple command used in the study.
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 |
---|
Kyphosis group
Subjects are community-dwelling elderly with different degrees of kyphosis, aged at least 60 years with a body mass index between 18.5-29.9
kg/m2 and OWD >0 cm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
KMD
Time Frame: 7 days
|
Kyphosis assessments using distance from the wall
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10MWT
Time Frame: 1 day
|
walking speed
|
1 day
|
FTSST
Time Frame: 1 day
|
Lower limb muscle strength
|
1 day
|
TUGT
Time Frame: 1 day
|
Balance control
|
1 day
|
6MinWT
Time Frame: 1 day
|
Walking endurance
|
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
February 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Anticipated)
August 1, 2017
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)
August 22, 2017
Last Update Submitted That Met QC Criteria
August 18, 2017
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHD57I0037
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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