NCT02914041

Brief 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?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

September 22, 2016

Last Update Submit

August 18, 2017

Conditions

Kyphosis

Keywords

KyphosisKyphosis wall distanceelderly

Outcome Measures

Primary Outcomes (1)

  • KMD

    Kyphosis assessments using distance from the wall

    7 days

Secondary Outcomes (4)

  • 10MWT

    1 day

  • FTSST

    1 day

  • TUGT

    1 day

  • 6MinWT

    1 day

Study Arms (1)

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.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Sugalya Amatachaya, PhD

    School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 26, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

August 1, 2017

Last Updated

August 22, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share