NCT02916784

Brief Summary

  1. 1.Were there differences in functional ability between ambulatory individuals with SCI who passed and failed the independent sit-to-stand (iSTS) task?
  2. 2.Did the ability of iSTS relate to ability of walking as determined using a type of AAD used?
  3. 3.What were factors associated with the ability of iSTS?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
Last Updated

September 27, 2016

Status Verified

November 1, 2015

Enrollment Period

3 months

First QC Date

September 22, 2016

Last Update Submit

September 23, 2016

Conditions

Keywords

Sit-to-standWalking devices

Outcome Measures

Primary Outcomes (1)

  • Independent sit-to-stand test

    Ability to perform sit-to-stand independently

    1 day

Secondary Outcomes (2)

  • Lower limb support during sit-to-stand test

    1 day

  • Timed up and go test

    1 day

Study Arms (2)

Sit-to-stand: Pass

The subjects seated on a standard armless chair with their back upright at 90 degrees against the backrest of the chair, feet placement on the floor with the heels at 10 cm behind the knees and their arms on their sides. Then they were instructed to stand up from the chair without using the arms. The ability was recorded as 'pass' if the subjects could safely rise from the chair without using their arms and with no more than contact guarding assist.

Sit-to-stand: Fail

The subjects seated on a standard armless chair with their back upright at 90 degrees against the backrest of the chair, feet placement on the floor with the heels at 10 cm behind the knees and their arms on their sides. Then they were instructed to stand up from the chair without using the arms. The ability was recorded as 'fail' if the subjects could not rise from the chair without using their arms and/or with more than contact guarding assist.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study is conducted in subjects with incomplete spinal cord injury (iSCI) who are able to walk independently with or without an ambulatory assistive device (AAD) from the Srinagarind hospital, KhonKaen University, Thailand.

You may qualify if:

  • 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 \[FIM locomotor (FIM-L) scores = 5 to 7\]

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

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
CASE CROSSOVER
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 27, 2016

Study Start

July 1, 2015

Primary Completion

October 1, 2015

Study Completion

July 1, 2016

Last Updated

September 27, 2016

Record last verified: 2015-11

Data Sharing

IPD Sharing
Will not share