Postural BalanceNCT03877367
Comparison of Balance Changes After Chiropractic Adjustments in Health Adults.
A study testing Upper extremity manipulation in people with Postural Balance and Musculoskeletal Manipulation, run by Parker University at 1 site in United States.
Trial summary
This study will examine the effect of upper and lower extremity manipulations on an upper extremity balancing task. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Balance, Musculoskeletal Manipulation
- What is being tested?
- Upper extremity manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2019to 24 Jul 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the age 18 years old and 35 years old
- Cleared to be treated in Parker Wellness Clinic
Who cannot join
- Hx of neurological disorders
- Hx of musculoskeletal disorders/injuries that could impact his/her ability to stand upright
- Currently known to be pregnant
- Compromised vision (beyond the wearing of corrective lenses)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Impact of Extremity Manipulation on an Upper Extremity (UE) Balancing Task
This study will examine the effect of upper and lower extremity manipulations on an upper extremity balancing task.
Read the detailed description
Spinal manipulation has long been thought to have beneficial effects on posture, balance and proprioception; however, only a single study has investigated the effect of chiropractic treatment of the extremities on balance and posture. In a previous study, it was noted that lower extremity manipulation led to more ordered behavior on a dynamic, lower extremity balance task. It was also found that upper extremity manipulation led to less ordered behavior with same lower extremity balance task. Further studies are needed not only to validate this theory, but to further clarify the mechanism regarding specificity of manipulation to task.
- Conditions
- Postural Balance, Musculoskeletal Manipulation
- Being tested
- Upper extremity manipulation
- Keywords
- Chiropractic manipulation, Extremity manipulation, Balance task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper extremity manipulationOther
Also called Manipulation
An upper extremity (glenohumeral, humeroulnar and radioulnar joints, bilaterally) or a lower extremity (coxofemoral, tibiofemoral, and tibiotalar, bilaterally) manipulation series.
| Study group | Role | What they receive |
|---|---|---|
| Upper Extremity Group, Day 1 | Experimental | Day 1: This group will receive a pre-test, upper extremity intervention, and post-test.
Day 2: This group will receive a pre-test, lower extremity intervention, and post-test. Receives: Other: Upper extremity manipulation |
| Lower Extremity Group, Day 2 | Experimental | Day 1: This group will receive a pre-test, lower extremity intervention, and post-test.
Day 2: This group will receive a pre-test, upper extremity intervention, and post-test. Receives: Other: Upper extremity manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head Sensor to calculate angle of head inclination
There will be a sensor placed on each participant's head (in a neoprene headband), as well as on the midpoint of the tube. The head sensor will be used to calculate the angle of head inclination. The sensor on the tube will be used to calculate Sample Entropy as well as general kinematics.
Measured: 30 seconds
Secondary outcomes (5)
Ground reaction force
Participants will be standing on a force plate that will characterize their ground reaction forces, eyes open without tube (EONT) versus eyes closed without the tube (ECNT).
Measured: less than 1 minute
Center of pressure
Participants will be standing on a force plate that will characterize their center of pressure, EONT versus eye open with the tube horizontally (EOWT).
Measured: less than 1 minute
Velocity to measure sway.
Participants will be standing on a force plate that will characterize their velocity of sway, EOWT versus eye closed with tube held horizontally (ECWT).
Measured: less than 1 minute
Sway: measuring distance
Participants will be standing on a force plate that will characterize their distance of sway, EOWT versus ECWT.
Measured: less than 1 minute
acceleration to measure sway
Participants will be standing on a force plate that will characterize their acceleration of sway, EOWT versus ECWT.
Measured: less than 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start22 Jul 2019
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
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 Postural BalanceStudies 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
- Model description
- The study will be a patient and outcome assessor blinded, cross-over randomized clinical trial. Participants will randomized into two groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston, Whittier University, University of Miami, Private Practice
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877367
- Sponsor's protocol ID
- Parker19_03
- Status last verified
- Sep 2019
- First submitted
- 13 Mar 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Malaya CA, Haworth J, Pohlman KA, Smith DL. Immediate impact of extremity manipulation on dual task performance: a randomized, crossover clinical trial. Chiropr Man Therap. 2021 Feb 5;29(1):6. doi: 10.1186/s12998-021-00366-5.
PubMed 33541378
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Impact of Extremity Manipulation on an Upper Extremity (UE) Balancing Task
- ClinicalTrials.gov ID
- NCT03877367
- Acronym / sponsor ID
- Parker19_03
- Conditions
- Postural Balance, Musculoskeletal Manipulation
- Keywords
- Chiropractic manipulation, Extremity manipulation, Balance task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Parker UniversityUniversity, hospital or other
- Collaborators
- University of Houston, Whittier University, University of Miami, Private Practice
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 15 Mar 2019 (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 will examine the effect of upper and lower extremity manipulations on an upper extremity balancing task.
Detailed description
Spinal manipulation has long been thought to have beneficial effects on posture, balance and proprioception; however, only a single study has investigated the effect of chiropractic treatment of the extremities on balance and posture. In a previous study, it was noted that lower extremity manipulation led to more ordered behavior on a dynamic, lower extremity balance task. It was also found that upper extremity manipulation led to less ordered behavior with same lower extremity balance task. Further studies are needed not only to validate this theory, but to further clarify the mechanism regarding specificity of manipulation to task.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be a patient and outcome assessor blinded, cross-over randomized clinical trial. Participants will randomized into two groups.
| Arm | Type | Receives |
|---|---|---|
| Upper Extremity Group, Day 1 | Experimental | Other: Upper extremity manipulationDay 1: This group will receive a pre-test, upper extremity intervention, and post-test. Day 2: This group will receive a pre-test, lower extremity intervention, and post-test. |
| Lower Extremity Group, Day 2 | Experimental | Other: Upper extremity manipulationDay 1: This group will receive a pre-test, lower extremity intervention, and post-test. Day 2: This group will receive a pre-test, upper extremity intervention, and post-test. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between the age 18 years old and 35 years old
- Cleared to be treated in Parker Wellness Clinic
Key exclusion criteria (4 listed)
- Hx of neurological disorders
- Hx of musculoskeletal disorders/injuries that could impact his/her ability to stand upright
- Currently known to be pregnant
- Compromised vision (beyond the wearing of corrective lenses)
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 |
|---|---|---|
| Upper extremity manipulationAlso: ManipulationAn upper extremity (glenohumeral, humeroulnar and radioulnar joints, bilaterally) or a lower extremity (coxofemoral, tibiofemoral, and tibiotalar, bilaterally) manipulation series. | Other | Lower Extremity Group, Day 2, Upper Extremity Group, Day 1 |
Primary outcome
Head Sensor to calculate angle of head inclination
Time frame: 30 seconds
There will be a sensor placed on each participant's head (in a neoprene headband), as well as on the midpoint of the tube. The head sensor will be used to calculate the angle of head inclination. The sensor on the tube will be used to calculate Sample Entropy as well as general kinematics.
5 secondary outcomes
Ground reaction force
Time frame: less than 1 minute
Center of pressure
Time frame: less than 1 minute
Velocity to measure sway.
Time frame: less than 1 minute
Sway: measuring distance
Time frame: less than 1 minute
acceleration to measure sway
Time frame: less than 1 minute
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 6 Sep 2019.
- Derived from this study: PubMed 33541378Malaya CA, Haworth J, Pohlman KA, Smith DL. Immediate impact of extremity manipulation on dual task performance: a randomized, crossover clinical trial. Chiropr Man Therap. 2021 Feb 5;29(1):6. doi: 10.1186/s12998-021-00366-5.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper extremity manipulation in people with Postural Balance and Musculoskeletal Manipulation, 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 2 inclusion and 4 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 6 Sep 2019. 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?
Head Sensor to calculate angle of head inclination (time frame: 30 seconds). 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 NCT03877367, 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 6 Sep 2019.