Injuries, Spinal CordNCT02917590
Dual-task Obstacle Crossing Training in Ambulatory Subjects With Spinal Cord Injury
A study testing Dual-task obstacle crossing training and Single-task obstacle crossing training in people with Injuries, Spinal Cord, run by Khon Kaen University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Injuries, Spinal Cord
- What is being tested?
- Dual-task obstacle crossing training and Single-task obstacle crossing training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
Read the detailed description
To compare immediate effects of dual-task and single-task obstacle crossing training in ambulatory subjects with spinal cord injury
- Conditions
- Injuries, Spinal Cord
- Being tested
- Dual-task obstacle crossing training, Single-task obstacle crossing training
- Keywords
- Spinal cord injury, dual-task obstacle crossing
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task obstacle crossing trainingOther
Obstacle crossing simultaneously a color word stroop task training
Single-task obstacle crossing trainingOther
Obstacle crossing training
| Study group | Role | What they receive |
|---|---|---|
| Dual-task obstacle crossing training | Experimental | 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. Receives: Other: Dual-task obstacle crossing training |
| Single-task obstacle crossing training | Sham comparator | 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. Receives: Other: Single-task obstacle crossing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
10MWT (Single-task)
Walking speed in single-task condition
Measured: 1 day
Secondary outcomes (3)
10MWT (Dual-task)
Walking speed in dual-task condition
Measured: 1 day
TUGT
Balance ability
Measured: 1 day
FTSST
Lower extremity muscle strength
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injuries, Spinal CordStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sugalya Amatachaya, Khon Kaen University
- Investigators
- Sugalya Amatachaya, PhD, Principal investigator, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917590
- Sponsor's protocol ID
- PHD/0128/2556
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2016
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Task Obstacle Crossing: Effects on Walking and Balance Ability, and Relationship With Falls in Independent Ambulatory Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02917590
- Acronym / sponsor ID
- PHD/0128/2556
- Conditions
- Injuries, Spinal Cord
- Keywords
- Spinal cord injury, dual-task obstacle crossing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-task obstacle crossing training | Experimental | Other: Dual-task obstacle crossing trainingThe 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. |
| Single-task obstacle crossing training | Sham comparator | Other: Single-task obstacle crossing trainingThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-task obstacle crossing trainingObstacle crossing simultaneously a color word stroop task training | Other | Dual-task obstacle crossing training |
| Single-task obstacle crossing trainingObstacle crossing training | Other | Single-task obstacle crossing training |
Primary outcome
10MWT (Single-task)
Time frame: 1 day
Walking speed in single-task condition
3 secondary outcomes
10MWT (Dual-task)
Time frame: 1 day
TUGT
Time frame: 1 day
FTSST
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sugalya Amatachaya, PhD principal investigator
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand
Questions about this trial
What is this clinical trial studying?
A study testing Dual-task obstacle crossing training and Single-task obstacle crossing training in people with Injuries, Spinal Cord, run by Khon Kaen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10MWT (Single-task) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.