KyphosisNCT02914041
Kyphotic Measure Using Distance From the Wall
An observational study of Kyphosis, run by Khon Kaen University.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Kyphosis
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Aug 2017
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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?
Read the 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.
- Conditions
- Kyphosis
- Keywords
- Kyphosis, Kyphosis wall distance, elderly
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
KMD
Kyphosis assessments using distance from the wall
Measured: 7 days
Secondary outcomes (4)
10MWT
walking speed
Measured: 1 day
FTSST
Lower limb muscle strength
Measured: 1 day
TUGT
Balance control
Measured: 1 day
6MinWT
Walking endurance
Measured: 1 day
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 startFeb 2016
- Primary completionDec 2016
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KyphosisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (estimated)
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, PhD, Principal investigator, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914041
- Sponsor's protocol ID
- PHD57I0037
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2016
- Last updated
- 22 Aug 2017
- 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 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kyphotic Measure Using Distance From the Wall: Reliability, Validity and Distance From the Wall to Indicate Risk for Spinal Fracture
- ClinicalTrials.gov ID
- NCT02914041
- Acronym / sponsor ID
- PHD57I0037
- Conditions
- Kyphosis
- Keywords
- Kyphosis, Kyphosis wall distance, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Aug 2017 (estimated)
- 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.
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?
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
KMD
Time frame: 7 days
Kyphosis assessments using distance from the wall
4 secondary outcomes
10MWT
Time frame: 1 day
FTSST
Time frame: 1 day
TUGT
Time frame: 1 day
6MinWT
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- 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, PhD 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?
An observational study of Kyphosis, 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Aug 2017. 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. 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?
Results are not available in the source record.
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?
KMD (time frame: 7 days). 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 22 Aug 2017.