Coordination and Balance DisturbancesNCT05226715
Effect of Lower Extremity Joint Manipulation on a Lower Extremity Somatosensory Illusion
A study testing chiropractic manual therapy in people with Coordination and Balance Disturbances and Healthy, run by Parker University at 1 site in United States.
Trial summary
The purpose of this study is to examine the influence of extremity manipulation on individual's center of pressure after they adapt to an ankle based illusion. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Coordination and Balance Disturbances, Healthy
- What is being tested?
- chiropractic manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 16 May 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No previous surgeries
- Not knowingly pregnant
- No neuromusculoskeletal injuries or systemic diseases that could affect an individual's ability to stand on an incline for 3 minutes with their eyes closed.
Who cannot join
- Weight over the force plate operating limit of 440 lbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effect of Lower Extremity Joint Manipulation on a Lower Extremity Somatosensory Illusion: a Preliminary, Randomized, Controlled Crossover Clinical Trial
The purpose of this study is to examine the influence of extremity manipulation on individual's center of pressure after they adapt to an ankle based illusion.
- Conditions
- Coordination and Balance Disturbances, Healthy
- Being tested
- chiropractic manual therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chiropractic manual therapyOther
high velocity low amplitude thrust into a human joint
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Received a bilateral, lower extremity manipulation series Receives: Other: chiropractic manual therapy |
| Control | No intervention | 30 seconds of lying supine on a chiropractic bench (control) without manual manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of pressure position
position in centimeters as evaluated by a force plate
Measured: baseline, immediately post-intervention, same day
Secondary outcomes (3)
Pathlength
cumulative distance traveled by center of pressure during trial
Measured: baseline, immediately post-intervention, same day
RMS
(Root mean square) measure of amplitude of center of pressure during trial
Measured: baseline, immediately post-intervention, same day
Mean velocity
average speed and direction of center of pressure during trial
Measured: baseline, immediately post-intervention, same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start14 May 2021
- Primary completion16 May 2021
- Study completion16 May 2021
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 Coordination and Balance DisturbancesStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher A Malaya, DC, Principal investigator, Parker University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226715
- Sponsor's protocol ID
- Parker
- Status last verified
- Feb 2022
- First submitted
- 1 Nov 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schueren S, Hunger H, Pham H, Smith DL, Layne C, Malaya CA. Immediate effect of lower extremity joint manipulation on a lower extremity somatosensory illusion: a randomized, controlled crossover clinical pilot study. Front Hum Neurosci. 2022 Nov 8;16:1011997. doi: 10.3389/fnhum.2022.1011997. eCollection 2022.
PubMed 36425882
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Lower Extremity Joint Manipulation on a Lower Extremity Somatosensory Illusion: a Preliminary, Randomized, Controlled Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT05226715
- Acronym / sponsor ID
- Parker
- Conditions
- Coordination and Balance Disturbances, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Parker UniversityUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 16 May 2021 (actual)
- Study completion
- 16 May 2021 (actual)
- First posted
- 7 Feb 2022 (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 purpose of this study is to examine the influence of extremity manipulation on individual's center of pressure after they adapt to an ankle based illusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: chiropractic manual therapyReceived a bilateral, lower extremity manipulation series |
| Control | No intervention | –30 seconds of lying supine on a chiropractic bench (control) without manual manipulation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No previous surgeries
- Not knowingly pregnant
- No neuromusculoskeletal injuries or systemic diseases that could affect an individual's ability to stand on an incline for 3 minutes with their eyes closed.
Key exclusion criteria (1 listed)
- Weight over the force plate operating limit of 440 lbs
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 |
|---|---|---|
| chiropractic manual therapyhigh velocity low amplitude thrust into a human joint | Other | Intervention |
Primary outcome
Center of pressure position
Time frame: baseline, immediately post-intervention, same day
position in centimeters as evaluated by a force plate
3 secondary outcomes
Pathlength
Time frame: baseline, immediately post-intervention, same day
RMS
Time frame: baseline, immediately post-intervention, same day
Mean velocity
Time frame: baseline, immediately post-intervention, same day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Derived from this study: PubMed 36425882Schueren S, Hunger H, Pham H, Smith DL, Layne C, Malaya CA. Immediate effect of lower extremity joint manipulation on a lower extremity somatosensory illusion: a randomized, controlled crossover clinical pilot study. Front Hum Neurosci. 2022 Nov 8;16:1011997. doi: 10.3389/fnhum.2022.1011997. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Coordination and Balance Disturbances
Recruiting
Virtual Reality for Pediatric Motor Rehabilitation.
Coordination and Balance Disturbances
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 A Malaya, DC principal investigator
Parker University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chiropractic manual therapy in people with Coordination and Balance Disturbances and Healthy, run by Parker University at 1 site in United States.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 14 Feb 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Center of pressure position (time frame: baseline, immediately post-intervention, same day). 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 NCT05226715, 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 14 Feb 2022.