Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles
1 other identifier
interventional
31
1 country
1
Brief Summary
This study evaluates the effect of a rotation based exercise program on core muscle thickness. Additionally, a second aim is to demonstrate the ability of a clinical assessment tool to identify muscle thickness changes. Half of participants receive the rotation based exercises, while the other half perform a traditional core exercise program. It was hypothesized that the rotation based exercises would result in greater changes in muscle thickness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2016
CompletedFirst Submitted
Initial submission to the registry
May 16, 2018
CompletedFirst Posted
Study publicly available on registry
May 29, 2018
CompletedResults Posted
Study results publicly available
September 7, 2020
CompletedSeptember 7, 2020
September 1, 2020
1.5 years
May 16, 2018
August 3, 2020
September 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Muscle Thickness
Musculoskeletal ultrasound measured changes in muscle thickness
Baseline and 10 minutes post intervention
Secondary Outcomes (1)
Changes in Clinical Muscle Assessment Using the Novel Sling Screen
Baseline and 10 minutes post intervention
Study Arms (2)
Rotation Exercises
EXPERIMENTAL8 minute program of rotation based exercises
Control Exercises
ACTIVE COMPARATOR8 minute program of traditional exercises
Interventions
The subjects received 7 trunk rotation stability exercises x 10 reps each
The subjects received 7 traditional exercises x 10 reps each
Eligibility Criteria
You may qualify if:
- ° Undergraduate and graduate subjects from the University of the Delaware student community.
You may not qualify if:
- You could be excluded if you have recently undergone surgery in the last 6 months.
- Currently suffering from low back pain.
- Or have a history of a neurological condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Delaware
Newark, Delaware, 19702, United States
Results Point of Contact
- Title
- Brian Catania
- Organization
- ChristianaCare
Study Officials
- STUDY DIRECTOR
Andrea DiTrani, PhD, ATC
Neumann University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physical Therapy Program Manager
Study Record Dates
First Submitted
May 16, 2018
First Posted
May 29, 2018
Study Start
February 25, 2015
Primary Completion
August 25, 2016
Study Completion
August 25, 2016
Last Updated
September 7, 2020
Results First Posted
September 7, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share