HealthyBalance1NCT03414749
Extremity Manipulation Impact on Postural Sway Characteristics
A study testing Lower Extremity First (LEF) and Upper Extremity First (UEF) in people with Healthy, run by Parker University at 1 site in United States.
Trial summary
This study will evaluate the multi-segmental postural sway after upper versus lower extremity manipulation. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lower Extremity First (LEF) and Upper Extremity First (UEF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2017to 9 Aug 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- student in Parker University's Doctor of Chiropractic program and patient at the Parker University Wellness Clinic;
- available to take part in the study for all 3 test days;
- willing to forgo all non-normal daily activities and chiropractic treatments during the test days;
Who cannot join
- pregnant;
- previous major injury involving the extremities;
- previous surgeries to an extremity joint; and
- known neurological or systemic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Balance Changes After Extremity Manipulation Therapy
This study will evaluate the multi-segmental postural sway after upper versus lower extremity manipulation.
Read the detailed description
The focus of this study is to explore the effect of upper and lower extremity chiropractic adjustments (manipulation) as well as surface condition (hard surface vs rocker board) on multisegmental postural control as represented by postural sway. Using a rocker (tilt) board, the participant cannot stand still, but has to adjust posture continuously to maintain balance. Body sways are considered to be self-induced because the design of the rocker board creates a natural instability without any external perturbation. This task provides a self-driven sensorimotor condition in addition to amplifying the sway dynamics. Because the rocker board has only one degree of freedom of motion, anteroposterior and lateral sways were considered separately on the device.
The investigators had the following hypotheses.
Hypothesis 1: Lower extremity adjustments will lead to reduced postural sway magnitude compared to upper extremity adjustments.
Hypothesis 2: Lower extremity adjustments will reduce sway variability of the rocker board, trunk and head compared to upper extremity adjustments.
Hypothesis 3: Lower extremity adjustments will facilitate the organization of sway behavior as assessed by the chaotic structure of sway.
- Conditions
- Healthy
- Being tested
- Lower Extremity First (LEF), Upper Extremity First (UEF)
- Keywords
- Chiropractic, postural sway, manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Extremity First (LEF)Procedure or surgery
The intervention for the LEF group was a non-specific long-axis distraction to the ankle, knee, and hip or shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience).
Upper Extremity First (UEF)Procedure or surgery
The intervention for the UEF group was a non-specific long-axis distraction to the shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience).
| Study group | Role | What they receive |
|---|---|---|
| Lower Extremity First (LEF) | Experimental | The treatment was a non-specific long-axis distraction to the ankle, knee, and hip provided was at the discretion of the clinic doctor (over 25 years experience). Receives: Procedure: Lower Extremity First (LEF) |
| Upper Extremity First (UEF) | Experimental | The treatment was a non-specific long-axis distraction to the shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience). Receives: Procedure: Upper Extremity First (UEF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Assessment
Each participant was fitted with two Shimmer3 sensors (Shimmer Sensing, Dublin, Ireland) on their head (occiput) and low back (over S2 tubercle) (see Figure 2) with a third Shimmer3 sensor placed on the surface (ground or rocker board). Participants were asked to perform a series of four postural tasks with two surface conditions (floor or rocker board) and two variations of each (eyes open or closed, and AP or ML rocker board direction). The conditions were randomized (using REDCap) such that either both floor or both rocker board conditions were performed first, with the remainder performed second. The order of variation within the surface type was held consistent for all occasions; eyes open then eyes closed on the floor, and AP then ML rotation direction on the rocker board.
Measured: Post Treatment on Day 1
Postural Assessment
Each participant was fitted with two Shimmer3 sensors (Shimmer Sensing, Dublin, Ireland) on their head (occiput) and low back (over S2 tubercle) (see Figure 2) with a third Shimmer3 sensor placed on the surface (ground or rocker board). Participants were asked to perform a series of four postural tasks with two surface conditions (floor or rocker board) and two variations of each (eyes open or closed, and AP or ML rocker board direction). The conditions were randomized (using REDCap) such that either both floor or both rocker board conditions were performed first, with the remainder performed second. The order of variation within the surface type was held consistent for all occasions; eyes open then eyes closed on the floor, and AP then ML rotation direction on the rocker board.
Measured: Pre Treatment on Day 2
Postural Assessment
Each participant was fitted with two Shimmer3 sensors (Shimmer Sensing, Dublin, Ireland) on their head (occiput) and low back (over S2 tubercle) (see Figure 2) with a third Shimmer3 sensor placed on the surface (ground or rocker board). Participants were asked to perform a series of four postural tasks with two surface conditions (floor or rocker board) and two variations of each (eyes open or closed, and AP or ML rocker board direction). The conditions were randomized (using REDCap) such that either both floor or both rocker board conditions were performed first, with the remainder performed second. The order of variation within the surface type was held consistent for all occasions; eyes open then eyes closed on the floor, and AP then ML rotation direction on the rocker board.
Measured: Post Treatment on Day 2
Postural Assessment
Each participant was fitted with two Shimmer3 sensors (Shimmer Sensing, Dublin, Ireland) on their head (occiput) and low back (over S2 tubercle) (see Figure 2) with a third Shimmer3 sensor placed on the surface (ground or rocker board). Participants were asked to perform a series of four postural tasks with two surface conditions (floor or rocker board) and two variations of each (eyes open or closed, and AP or ML rocker board direction). The conditions were randomized (using REDCap) such that either both floor or both rocker board conditions were performed first, with the remainder performed second. The order of variation within the surface type was held consistent for all occasions; eyes open then eyes closed on the floor, and AP then ML rotation direction on the rocker board.
Measured: Pre Treatment on Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start24 Jul 2017
- Primary completion9 Aug 2017
- Study completion9 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- This study used a randomized, crossover experimental design over three days of testing.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, Whittier University, University of Houston
- Responsible party
- Sponsor
- Investigators
- Katherine A Pohlman, DC, MS, Study director, Parker University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414749
- Sponsor's protocol ID
- Parker17_001
- Acronym
- Balance1
- Status last verified
- Feb 2020
- First submitted
- 22 Jan 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Balance Changes After Extremity Manipulation Therapy
- ClinicalTrials.gov ID
- NCT03414749
- Acronym / sponsor ID
- Balance1 / Parker17_001
- Conditions
- Healthy
- Keywords
- Chiropractic, postural sway, manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Parker UniversityUniversity, hospital or other
- Collaborators
- University of Miami, Whittier University, University of Houston
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 9 Aug 2017 (actual)
- Study completion
- 9 Aug 2017 (actual)
- First posted
- 30 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.
This study will evaluate the multi-segmental postural sway after upper versus lower extremity manipulation.
Detailed description
The focus of this study is to explore the effect of upper and lower extremity chiropractic adjustments (manipulation) as well as surface condition (hard surface vs rocker board) on multisegmental postural control as represented by postural sway. Using a rocker (tilt) board, the participant cannot stand still, but has to adjust posture continuously to maintain balance. Body sways are considered to be self-induced because the design of the rocker board creates a natural instability without any external perturbation. This task provides a self-driven sensorimotor condition in addition to amplifying the sway dynamics. Because the rocker board has only one degree of freedom of motion, anteroposterior and lateral sways were considered separately on the device.
The investigators had the following hypotheses.
Hypothesis 1: Lower extremity adjustments will lead to reduced postural sway magnitude compared to upper extremity adjustments.
Hypothesis 2: Lower extremity adjustments will reduce sway variability of the rocker board, trunk and head compared to upper extremity adjustments.
Hypothesis 3: Lower extremity adjustments will facilitate the organization of sway behavior as assessed by the chaotic structure of sway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a randomized, crossover experimental design over three days of testing.
| Arm | Type | Receives |
|---|---|---|
| Lower Extremity First (LEF) | Experimental | Procedure: Lower Extremity First (LEF)The treatment was a non-specific long-axis distraction to the ankle, knee, and hip provided was at the discretion of the clinic doctor (over 25 years experience). |
| Upper Extremity First (UEF) | Experimental | Procedure: Upper Extremity First (UEF)The treatment was a non-specific long-axis distraction to the shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience). |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- student in Parker University's Doctor of Chiropractic program and patient at the Parker University Wellness Clinic;
- available to take part in the study for all 3 test days;
- willing to forgo all non-normal daily activities and chiropractic treatments during the test days;
Key exclusion criteria (4 listed)
- pregnant;
- previous major injury involving the extremities;
- previous surgeries to an extremity joint; and
- known neurological or systemic diseases.
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 |
|---|---|---|
| Lower Extremity First (LEF)The intervention for the LEF group was a non-specific long-axis distraction to the ankle, knee, and hip or shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience). | Procedure or surgery | Lower Extremity First (LEF) |
| Upper Extremity First (UEF)The intervention for the UEF group was a non-specific long-axis distraction to the shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience). | Procedure or surgery | Upper Extremity First (UEF) |
Primary outcome
Postural Assessment
Time frame: Post Treatment on Day 1
Each participant was fitted with two Shimmer3 sensors (Shimmer Sensing, Dublin, Ireland) on their head (occiput) and low back (over S2 tubercle) (see Figure 2) with a third Shimmer3 sensor placed on the surface (ground or rocker board). Participants were asked to perform a series of four postural tasks with two surface conditions (floor or rocker board) and two variations of each (eyes open or closed, and AP or ML rocker board direction). The conditions were randomized (using REDCap) such that either both floor or both rocker board conditions were performed first, with the remainder performed second. The order of variation within the surface type was held consistent for all occasions; eyes open then eyes closed on the floor, and AP then ML rotation direction on the rocker board.
Postural Assessment
Time frame: Pre Treatment on Day 2
Each participant was fitted with two Shimmer3 sensors (Shimmer Sensing, Dublin, Ireland) on their head (occiput) and low back (over S2 tubercle) (see Figure 2) with a third Shimmer3 sensor placed on the surface (ground or rocker board). Participants were asked to perform a series of four postural tasks with two surface conditions (floor or rocker board) and two variations of each (eyes open or closed, and AP or ML rocker board direction). The conditions were randomized (using REDCap) such that either both floor or both rocker board conditions were performed first, with the remainder performed second. The order of variation within the surface type was held consistent for all occasions; eyes open then eyes closed on the floor, and AP then ML rotation direction on the rocker board.
Postural Assessment
Time frame: Post Treatment on Day 2
Each participant was fitted with two Shimmer3 sensors (Shimmer Sensing, Dublin, Ireland) on their head (occiput) and low back (over S2 tubercle) (see Figure 2) with a third Shimmer3 sensor placed on the surface (ground or rocker board). Participants were asked to perform a series of four postural tasks with two surface conditions (floor or rocker board) and two variations of each (eyes open or closed, and AP or ML rocker board direction). The conditions were randomized (using REDCap) such that either both floor or both rocker board conditions were performed first, with the remainder performed second. The order of variation within the surface type was held consistent for all occasions; eyes open then eyes closed on the floor, and AP then ML rotation direction on the rocker board.
Postural Assessment
Time frame: Pre Treatment on Day 3
Each participant was fitted with two Shimmer3 sensors (Shimmer Sensing, Dublin, Ireland) on their head (occiput) and low back (over S2 tubercle) (see Figure 2) with a third Shimmer3 sensor placed on the surface (ground or rocker board). Participants were asked to perform a series of four postural tasks with two surface conditions (floor or rocker board) and two variations of each (eyes open or closed, and AP or ML rocker board direction). The conditions were randomized (using REDCap) such that either both floor or both rocker board conditions were performed first, with the remainder performed second. The order of variation within the surface type was held consistent for all occasions; eyes open then eyes closed on the floor, and AP then ML rotation direction on the rocker board.
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 7 Feb 2020.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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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.
Katherine A Pohlman, DC, MS study director
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 Lower Extremity First (LEF) and Upper Extremity First (UEF) in people with 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 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 7 Feb 2020. 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?
Postural Assessment (time frame: Post Treatment on Day 1). The study lists 4 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 7 Feb 2020.