Ambulation DifficultyNCT03405896
The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.
A study testing Turning in people with Ambulation Difficulty, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The Validity and Reliability of a Wearable System for Assessing Turning Characteristics. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ambulation Difficulty
- What is being tested?
- Turning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Aug 2017to 23 Aug 2019
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to walk 10 m independently without any device.
Who cannot join
- Dizzy causing by eye disorders or vestibular disease.
- Any disease which involved in gait performance.
- Can't follow the order by investigator during task.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang-Ming University
Taipei, 112
Yea-Ru Yang, PhD, +886-2-28267279, yryang@ym.edu.tw
About this study
The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.
Read the detailed description
Subjects are reclaimed to finish several turning task under different turning angle.
The wearable system is patched on both subjects' legs and waist, to assess turning characteristics under different turning angle.
- Conditions
- Ambulation Difficulty
- Being tested
- Turning
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TurningOther
start to walk with normal speed, and then turn to approach the terminal under different angle.
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | Experimental | Not described Receives: Other: Turning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turning step count
record numbers of step during turning
Measured: pre-test and post-test within a week
Turing time
record second which subject spend during turning
Measured: pre-test and post-test within a week
Stride length during turning
record the distance of bipedal stride length respectively
Measured: pre-test and post-test within a week
Walking speed approached turning
record the velocity and change of velocity before start turning
Measured: pre-test and post-test within a week
Turning angle
record the total turning angle and bipedal turning angle each step
Measured: pre-test and post-test within a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start24 Aug 2017
- Primary completion23 Aug 2019 (estimated)
- Study completion23 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ambulation DifficultyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405896
- Sponsor's protocol ID
- YM106038E
- Status last verified
- Nov 2018
- First submitted
- 8 Jan 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.
- ClinicalTrials.gov ID
- NCT03405896
- Acronym / sponsor ID
- YM106038E
- Conditions
- Ambulation Difficulty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 23 Aug 2019 (estimated)
- Study completion
- 23 Aug 2019 (estimated)
- First posted
- 23 Jan 2018 (actual)
- 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.
The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.
Detailed description
Subjects are reclaimed to finish several turning task under different turning angle.
The wearable system is patched on both subjects' legs and waist, to assess turning characteristics under different turning angle.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | Experimental | Other: Turning |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Able to walk 10 m independently without any device.
Key exclusion criteria (3 listed)
- Dizzy causing by eye disorders or vestibular disease.
- Any disease which involved in gait performance.
- Can't follow the order by investigator during task.
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 |
|---|---|---|
| Turningstart to walk with normal speed, and then turn to approach the terminal under different angle. | Other | Normal subjects |
Primary outcome
Turning step count
Time frame: pre-test and post-test within a week
record numbers of step during turning
Turing time
Time frame: pre-test and post-test within a week
record second which subject spend during turning
Stride length during turning
Time frame: pre-test and post-test within a week
record the distance of bipedal stride length respectively
Walking speed approached turning
Time frame: pre-test and post-test within a week
record the velocity and change of velocity before start turning
Turning angle
Time frame: pre-test and post-test within a week
record the total turning angle and bipedal turning angle each step
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turning in people with Ambulation Difficulty, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 1 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Yea-Ru Yang, PhD (+886-2-28267279, yryang@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turning step count (time frame: pre-test and post-test within a week). The study lists 5 primary outcomes in all. 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 6 Nov 2018.