Back to resultsDual-task Obstacle Crossing Training in Ambulatory Subjects With Spinal Cord Injury
Primary Purpose
Injuries, Spinal Cord
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dual-task obstacle crossing training
Single-task obstacle crossing training
Sponsored by
About this trial
This is an interventional treatment trial for Injuries, Spinal Cord focused on measuring Spinal cord injury, dual-task obstacle crossing
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Dual-task obstacle crossing training
Single-task obstacle crossing training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
10MWT (Single-task)
Walking speed in single-task condition
Secondary Outcome Measures
10MWT (Dual-task)
Walking speed in dual-task condition
TUGT
Balance ability
FTSST
Lower extremity muscle strength
Full Information
NCT ID
NCT02917590
First Posted
September 22, 2016
Last Updated
September 26, 2016
Sponsor
Khon Kaen University
1. Study Identification
Unique Protocol Identification Number
NCT02917590
Brief Title
Dual-task Obstacle Crossing Training in Ambulatory Subjects With Spinal Cord Injury
Official Title
Dual Task Obstacle Crossing: Effects on Walking and Balance Ability, and Relationship With Falls in Independent Ambulatory Patients With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
To compare immediate effects of dual-task and single-task obstacle crossing training in ambulatory subjects with spinal cord injury
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries, Spinal Cord
Keywords
Spinal cord injury, dual-task obstacle crossing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dual-task obstacle crossing training
Arm Type
Experimental
Arm Description
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.
Arm Title
Single-task obstacle crossing training
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dual-task obstacle crossing training
Intervention Description
Obstacle crossing simultaneously a color word stroop task training
Intervention Type
Other
Intervention Name(s)
Single-task obstacle crossing training
Intervention Description
Obstacle crossing training
Primary Outcome Measure Information:
Title
10MWT (Single-task)
Description
Walking speed in single-task condition
Time Frame
1 day
Secondary Outcome Measure Information:
Title
10MWT (Dual-task)
Description
Walking speed in dual-task condition
Time Frame
1 day
Title
TUGT
Description
Balance ability
Time Frame
1 day
Title
FTSST
Description
Lower extremity muscle strength
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sugalya Amatachaya, PhD
Organizational Affiliation
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dual-task Obstacle Crossing Training in Ambulatory Subjects With Spinal Cord Injury
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