Metabolic Cost of Walking With Arm Swing Assistive DeviceNCT03689647
Using the Arms to Drive the Legs During Walking
A study testing Arm Swing Driven Assistive Apparatus in people with Metabolic Cost of Walking With Arm Swing Assistive Device, run by University of Houston.
Trial summary
This study aims to understand and compare the metabolic and mechanical demands placed on the body while walking normally and walking with the use of an apparatus that drives leg swing through the use of the arms. Read more about this study
- Who is it for?
- Ages 18 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Cost of Walking With Arm Swing Assistive Device
- What is being tested?
- Arm Swing Driven Assistive Apparatus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 31 Dec 2018
- 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 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy and free from neurological disease and/or body related injury
- Community-dwelling young men and women 18-36 yrs
- Use and be contacted by telephone
- Speak, read, understand, and complete a questionnaire in English
- Body mass index < 30 kg/m2
Who cannot join
- not of the specified age range or Body Mass Index
- inadequate aerobic fitness training
- answering "no" to question #3 on Screening Form ("Is participant in good general health?")
- answering "yes" to:
- question #4 ("any difficulty with mobility?")
- question #5 ("problems with balance/dizziness?")
Show all 14Show fewer
- question #6 ("lingering symptoms/pain from injury?")
- question #7 ("chest pain/shortness of breath?")
- question #8 ("high blood pressure/hypertension?"), or
- questions #9, 10, 11 ("first degree family history of heart attack?")
- question #12 ("smoke cigarettes?")
- question #13 ("diabetes?")
- question #14 ("high cholesterol?")
- question #15 ("Is participant pregnant?")
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Reducing Metabolic Cost of Walking by Exploiting Arm Swing to Drive Leg Swing
This study aims to understand and compare the metabolic and mechanical demands placed on the body while walking normally and walking with the use of an apparatus that drives leg swing through the use of the arms. This information will help the investigators identify how arm swing mechanics helps minimize energy demands and to use this knowledge to design walking rehabilitation interventions in the future.
- Being tested
- Arm Swing Driven Assistive Apparatus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm Swing Driven Assistive ApparatusDevice
The investigators are testing a simple, custom built apparatus to determine if it can facilitate the use of the arms to swing the legs during walking. More specifically, the investigators will measure how this assistive apparatus affects the metabolic cost and biomechanics of walking.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Experimental | Experimental | Each participant will act as their own control with variables of interest measured while walking without the assistive device and while walking with the assistive device. Receives: Device: Arm Swing Driven Assistive Apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Cost
Change in Metabolic Cost
Measured: Change from walking without assistive apparatus to walking with assistive apparatus. Measures of metabolic cost are completed within a 3-hour time window during a single laboratory visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Cost of Walking With Arm Swing Assistive DeviceStudies 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
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Arellano, University of Houston
- Investigators
- Christopher J Arellano, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689647
- Sponsor's protocol ID
- STUDY00001219
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vega D, Arellano CJ. Using a simple rope-pulley system that mechanically couples the arms, legs, and treadmill reduces the metabolic cost of walking. J Neuroeng Rehabil. 2021 Jun 7;18(1):96. doi: 10.1186/s12984-021-00887-3.
PubMed 34098979
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Metabolic Cost of Walking by Exploiting Arm Swing to Drive Leg Swing
- ClinicalTrials.gov ID
- NCT03689647
- Acronym / sponsor ID
- STUDY00001219
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 28 Sep 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.
This study aims to understand and compare the metabolic and mechanical demands placed on the body while walking normally and walking with the use of an apparatus that drives leg swing through the use of the arms. This information will help the investigators identify how arm swing mechanics helps minimize energy demands and to use this knowledge to design walking rehabilitation interventions in the future.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Experimental | Experimental | Device: Arm Swing Driven Assistive ApparatusEach participant will act as their own control with variables of interest measured while walking without the assistive device and while walking with the assistive device. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Apparently healthy and free from neurological disease and/or body related injury
- Community-dwelling young men and women 18-36 yrs
- Use and be contacted by telephone
- Speak, read, understand, and complete a questionnaire in English
- Body mass index < 30 kg/m2
Key exclusion criteria (14 listed)
- not of the specified age range or Body Mass Index
- inadequate aerobic fitness training
- answering "no" to question #3 on Screening Form ("Is participant in good general health?")
- answering "yes" to:
- question #4 ("any difficulty with mobility?")
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 |
|---|---|---|
| Arm Swing Driven Assistive ApparatusThe investigators are testing a simple, custom built apparatus to determine if it can facilitate the use of the arms to swing the legs during walking. More specifically, the investigators will measure how this assistive apparatus affects the metabolic cost and biomechanics of walking. | Device | Single Group Experimental |
Primary outcome
Metabolic Cost
Time frame: Change from walking without assistive apparatus to walking with assistive apparatus. Measures of metabolic cost are completed within a 3-hour time window during a single laboratory visit.
Change in Metabolic Cost
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Derived from this study: PubMed 34098979Vega D, Arellano CJ. Using a simple rope-pulley system that mechanically couples the arms, legs, and treadmill reduces the metabolic cost of walking. J Neuroeng Rehabil. 2021 Jun 7;18(1):96. doi: 10.1186/s12984-021-00887-3.
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.
Christopher J Arellano, PhD principal investigator
University of Houston
Questions about this trial
What is this clinical trial studying?
A study testing Arm Swing Driven Assistive Apparatus in people with Metabolic Cost of Walking With Arm Swing Assistive Device, run by University of Houston.
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 5 inclusion and 14 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 2 Oct 2018. 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. 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 Christopher J Arellano, PhD (713-743-9709, carellano@uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Cost (time frame: Change from walking without assistive apparatus to walking with assistive apparatus. Measures of metabolic cost are completed within a 3-hour time window during a single laboratory visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03689647, which also lists 1 linked publication.
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 2 Oct 2018.