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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03625193
Other study ID # PHD02232558
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date August 31, 2019

Study information

Verified date August 2018
Source Khon Kaen University
Contact Lalita Khuna, PhD student
Phone +66637391999
Email lalitakhuna@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

1. Do different arm placements (including arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) influence outcomes of sit-to-stand test (STST) in ambulatory individuals with spinal cord injury (SCI)?

2. What are the factors associated with ability to perform STST in ambulatory individuals with SCI?

3. Are the single-time sit-to-stand test (STSST) and five-time sit-to-stand test (FTSST) reliable, valid and responsive to determine functional alteration in ambulatory individuals with SCI?


Description:

- To cross-sectionally compare characteristics (duration and amount of lower limb loading) of STS movements among 4 arm placement conditions (arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) in ambulatory patients with SCI.

- To investigate reliability (inter-rater, intra-rater, and test-retest), standard error of measurement and minimal detectable changes of the STSST and FTSST in ambulatory patients with SCI.

- To investigate concurrent validity and factors associated with ability of the STSST and FTSST in ambulatory patients with SCI.

- To investigate the ability of the STSST and FTSST to predict the risk of falls over 1, 3 and 6 months in ambulatory patients with SCI.

- To investigate internal and external responsiveness of the STSST and FTSST to detect changes on walking ability over 1, 3 and 6 months in ambulatory patients with SCI.

- To estimate the minimal clinically important difference or clinical significance of the FTSST in ambulatory patients with SCI.


Recruitment information / eligibility

Status Recruiting
Enrollment 182
Est. completion date August 31, 2019
Est. primary completion date December 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Body mass index (BMI) between 18.5 - 29.9 kg/m2

- Having an incomplete SCI from traumatic or non-traumatic causes

- Ability of independent standing up from a chair with or without hand support

- Ability of independent walking with or without walking device over at least 10 meters continuously.

- Ability to follow commands used in the studies

Exclusion Criteria:

Any ambulatory individuals with incomplete SCI who present signs and symptoms that might affect ability to perform STST will be excluded from the study such as

- Pain in the muscles or joints with an intensity of pain more than 5 out of 10 on a numeric rating scale (NRS)

- Joint deformities that affect mobility

- Other neurological disorders such as having brain lesions

- Unstable medical conditions

- Pregnancy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Faculty of Associated Medical Science, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District Khon Kaen

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ability to perform single and five times sit-to-stand test among 4 arm conditions Ability to execute a single time sit-to-stand and time used for five times sit-to-stand Change over 6 months
Secondary 10-meter walk test Change in walking speed during 6-month follow-up Change over 6 months
Secondary Fall events Incidence of fall during 6-month follow-up Over 6 months
Secondary Global rating of change score (GRC score) Level of change in subjects' independence in activities of daily life. The GRC score is divided into 15-point scale from "-7" (a very great deal worse) to "0" (about the same/ not change) to "7" (a very great deal better). Change over 6 months
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