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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02916784
Other study ID # 571H104
Secondary ID
Status Completed
Phase N/A
First received September 22, 2016
Last updated September 23, 2016
Start date July 2015
Est. completion date July 2016

Study information

Verified date November 2015
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority Thailand: Khon Kaen University Ethics Committee for Human Research
Study type Observational

Clinical Trial Summary

1. Were there differences in functional ability between ambulatory individuals with SCI who passed and failed the independent sit-to-stand (iSTS) task?

2. Did the ability of iSTS relate to ability of walking as determined using a type of AAD used?

3. What were factors associated with the ability of iSTS?


Description:

- To evaluate the proportion and compare functional abilities between subjects who passed and failed the independent sit-to-stand (iSTS) task.

- To assess the relationship between ability of iSTS and types of AAD used.

- To investigate factors associated with the ability of iSTS.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date July 2016
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ambulatory patients with iSCI from both non-traumatic and traumatic causes

- Aged at least 18 years

- Who are able to walk independently with or without AADs at least 15 meters continuously [FIM locomotor (FIM-L) scores = 5 to 7]

Exclusion Criteria:

- Any patients with conditions that might affect ambulatory ability; such as brain function disorders, visual deficits, musculoskeletal pain (VAS > 5), deformity of the musculoskeletal system, unable to follow a command of the tests, unstable medical conditions.

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Outcome

Type Measure Description Time frame Safety issue
Primary Independent sit-to-stand test Ability to perform sit-to-stand independently 1 day Yes
Secondary Lower limb support during sit-to-stand test Percent of body-weight support during sit-to-stand performance 1 day Yes
Secondary Timed up and go test Ability of dynamic balance control 1 day Yes
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