NCT02913911

Brief Summary

  • Does the utility of external feedback in terms of goal-directed LLL approach during STS training immediately improve functional ability relating to walking in ambulatory patients with SCI?
  • Does the utility of LLL feedback improve functional ability relating to walking in ambulatory patients with SCI after 2-week training?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Status
completed

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

November 1, 2015

Completed
11 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
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

September 22, 2016

Last Update Submit

November 3, 2018

Conditions

Injuries, Spinal Cord

Keywords

feedback

Outcome Measures

Primary Outcomes (1)

  • 10MWT

    walking speed test

    2 weeks

Study Arms (2)

Feedback

EXPERIMENTAL

Subjects will be trained using the sit-to-stand weight-taking machine. Prior to the training, subjects sit in a standard sitting position. Then they will be instructed to take most of their body-weight onto the legs while they standing up where the light bars will be gradually lightened from the red, yellow and green zones according to the level of LLL. Then they stand up, hold a standing position for 3-5 seconds and sit-down with always maximize their body-weight onto their legs during performing the task in which the green zone will always be lightened.

Other: feedback

No feedback

SHAM COMPARATOR

Subjects will be trained using the same instruction and protocol as the experimental group, but without the provision of external feedback.

Other: feedback

Interventions

feedbackOTHER

Sit to stand training with external feedback

FeedbackNo feedback

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulatory spinal cord injury patients

You may not qualify if:

  • Deformity of musculoskeletal system

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, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
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

November 1, 2015

Primary Completion

August 1, 2017

Study Completion

July 1, 2018

Last Updated

November 6, 2018

Record last verified: 2015-11

Data Sharing

IPD Sharing
Will not share