- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02917590
Dual-task Obstacle Crossing Training in Ambulatory Subjects With Spinal Cord Injury
September 26, 2016 updated by: Sugalya Amatachaya, Khon Kaen University
Dual Task Obstacle Crossing: Effects on Walking and Balance Ability, and Relationship With Falls in Independent Ambulatory Patients With Spinal Cord Injury
Is dual-task obstacle crossing training more efficiently than single-task obstacle crossing training on the improvement of walking ability, balance ability, and lower extremity muscle strength in ambulatory subjects with spinal cord injury
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
To compare immediate effects of dual-task and single-task obstacle crossing training in ambulatory subjects with spinal cord injury
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- independent ambulatory subjects with
- traumatic causes or non-progressive diseases
- sub-acute and chronic stage of injury (at least 3 month after injury)
- body mass index (BMI) between 18.5-29.9 kg/m2
- walk independently for at least 17 meters with or without assistive devices (Functional Independence Measure Locomotor (FIM-L) scores 5-7)
- able to read Thai
Exclusion Criteria:
- pain in the musculoskeletal system with a pain scale more than 5 out of 10 on a the visual analog scale (VAS)
- deformity in the joints that affect ambulatory ability
- unable to understand the commands and tests used in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dual-task obstacle crossing training
The four obstacles in the sizes of 4cm wide, 8cm wide, 4cm high, and 8cm high are randomly placed along a 10-meter walkway in 2-meter intervals.
Subjects are instructed to walk continuously over obstacles at their comfortable speed, as good as they can without contact the obstacles by their leg or device.
During walk over obstacles, subjects asked to perform simultaneously with a color word stroop task which requires subjects to see and answer the color of the name of a color words in the monitor (ignore the meaning) as quickly as possible, and loudly.
|
Obstacle crossing simultaneously a color word stroop task training
|
Sham Comparator: Single-task obstacle crossing training
The four obstacles in the sizes of 4cm wide, 8cm wide, 4cm high, and 8cm high are randomly placed along a 10-meter walkway in 2-meter intervals.
Subjects are asked to walk continuously over obstacles at their comfortable speed, as good as they can without contact the obstacles by their leg or device.
|
Obstacle crossing training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10MWT (Single-task)
Time Frame: 1 day
|
Walking speed in single-task condition
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10MWT (Dual-task)
Time Frame: 1 day
|
Walking speed in dual-task condition
|
1 day
|
TUGT
Time Frame: 1 day
|
Balance ability
|
1 day
|
FTSST
Time Frame: 1 day
|
Lower extremity muscle strength
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sugalya Amatachaya, PhD, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Anticipated)
February 1, 2017
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
September 26, 2016
First Posted (Estimate)
September 28, 2016
Study Record Updates
Last Update Posted (Estimate)
September 28, 2016
Last Update Submitted That Met QC Criteria
September 26, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHD/0128/2556
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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