NCT04374227

Brief Summary

Participants will be recruited from the Des Moines University community and randomized into treatment and control groups. The treatment group will undergo three treatments one week apart. The control group will have an osteopathic structural exam without treatment. During the first treatment weeks both groups will undergo balance testing on a force plate pre and post intervention. Additional balance testing will take place one week after last intervention. Six variables will be compared between groups used a linear mixed model analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

April 29, 2020

Last Update Submit

May 1, 2020

Conditions

Outcome Measures

Primary Outcomes (6)

  • Length of pathway of center of mass

    the center of mass of the participant is tracked on the force plate and the overall length it travels will be recorded

    60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell

  • area covered by center of mass

    the center of mass of the participant is tracked on the force plate and its total area covered was measured

    60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell

  • velocity of center of mass

    the center of mass of the participant is tracked on the force plate and the velocity at which that point moved was measured

    60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell

  • medial-lateral sway

    the center of mass of the participant is tracked on the force plate and the amount of lateral movement the point had was measured

    60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell

  • anterior-posterior sway

    the center of mass of the participant is tracked on the force plate and the amount of front-to-back movement the point had was measured

    60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell

  • Time

    we measured the amount of time participants were able to stand upright without touching the ground or having one leg touch the other in the single-leg tests

    60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell

Study Arms (2)

Treatment Group

EXPERIMENTAL

The treatment group received three osteopathic manipulative treatments once a week for three weeks. The osteopathic manipulative treatment was a full body treatment based upon Dr. Zink's model of a common compensatory pattern.

Procedure: Osteopathic Manipulative Treatment

Control Group

NO INTERVENTION

This group received an osteopathic structural exam once a week for three weeks without any treatment performed.

Interventions

Body regions that were treated included head, cervical, thoracic, ribs, lumbar, pelvis, sacrum, lower extremity, and upper extremity.

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be 18-40 years old
  • Have the ability to give consent
  • Be able to bare weight on both feet

You may not qualify if:

  • had manipulation performed by a D.O., physical therapist, or chiropractor in the last two months,
  • had surgery in the six months
  • had broken or fractured a bone in the last six months
  • have an abnormal neurological exam
  • cerebellar dysfunction or ataxia
  • has a condition that impairs balance (including orthostatic hypertension,otoneurologic conditions, or arrhythmias)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Des Moines University

Des Moines, Iowa, 50311, United States

Location

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The person running the force plate and its analysis was blind to who was in the treatment group and who was not because the analysis and treatments were given in different rooms.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The subjects were randomized into treatment or control groups. The treatment group for week 1 completed two measurements (before and after) and one treatment. Week 2 the treatment group received a treatment. Week 3 the treatment group received a treatment. Week 2 they completed one measurement. The control group completed two measurements and an assessment during week 1. They completed an assessment during weeks 2 and 3, and then completed a measurement during week 4.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 5, 2020

Study Start

October 16, 2019

Primary Completion

November 21, 2019

Study Completion

November 21, 2019

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations