Study Stopped
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Effects on Shoulder Pain of Simulated Hyper-gravity During Rehabilitation Exercises
1 other identifier
interventional
N/A
1 country
2
Brief Summary
Determine if adding "extra-gravity" (sustained increase in vertical loading) during standard rehabilitation exercises has a beneficial effect on pain reduction in subjects suffering from shoulder pain of different origin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2015
2 active sites
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
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 23, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFebruary 20, 2017
February 1, 2017
1.3 years
October 23, 2015
February 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in pain level
The patient will grade the pain level using a numeric pain scale (0 no pain; 10 unbearable pain requiring pain medication). Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
three months
Secondary Outcomes (4)
Changes in Stability Score
three months
Changes in shoulder range of motion
three months
Changes in Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
three months
Test of Sustained Selective Attention (TOSSA)
three months
Study Arms (4)
hypergravity WITH isometric load
EXPERIMENTALPatient performing rehabilitation exercises under hypergravity as well as loaded isometric squats
hypergravity WITHOUT isometric load
EXPERIMENTALPatient performing rehabilitation exercises under hypergravity
normal gravity WITH isometric load
EXPERIMENTALPatient performing rehabilitation exercises under normal gravity as well as loaded isometric squats
normal gravity WITHOUT isometric load
ACTIVE COMPARATORPatient performing rehabilitation exercises under normal gravity
Interventions
the rubber bands attached to the waist belt are tighten to simulate extra gravity during every exercise the subject performs while standing
at the end of the therapy session the subject will perform 2 sets of one minute each of a 33% squat under load
the rubber bands attached to the waist belt are NOT tighten so the subject performs the exercises in normal gravity
Eligibility Criteria
You may qualify if:
- Diagnosis of shoulder pain (potentially including rotator cuff pathology, impingement, bursitis, SLAP tear)
You may not qualify if:
- adhesive capsulitis, fracture, dislocation, inflammatory arthritis, cancer, ligament disruption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
FIFE Therapy
Savannah, Georgia, 31404, United States
Optim Orthopedics - DeRenne
Savannah, Georgia, 31405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederick R Carrick, PhD
Carrick Institute for Graduate Studies
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 23, 2015
First Posted
October 28, 2015
Study Start
October 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
February 20, 2017
Record last verified: 2017-02