Diabetic Shoulder Mobility
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02162212|
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : November 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Other: Optimized Shoulder Movement Program Other: ADA Guideline Instructed||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Diabetic Upper Extremity Pathophysiology, Limited Joint Mobility and Disability|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||October 12, 2016|
|Actual Study Completion Date :||October 12, 2016|
Active Comparator: ADA guideline Instructed
The control intervention will be instruction in basic wellness activities according to the American Diabetes Association guidelines
Other: ADA Guideline Instructed
The ADA guideline instructions are to include: blood sugar control (goal is A1c < 7.0%), physical activity (150 minutes/week of moderate intensity aerobic activity), foot care (examine feet daily, monofilament testing), and blood pressure control (goal is <130/80). Participants will receive a logbook to record daily outcomes. The goal of this intervention is to control for personal interactions with investigators and provide useful information for disease management but not provide intervention that likely would improve shoulder joint motion. The control group will be given instruction in the exercise program at the end of the 1 year study period.
Experimental: Optimized Shoulder Movement Program
The experimental intervention is the Optimized Shoulder Movement Program. Participants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation, and active shoulder motion based on the participant's baseline "activity count" .
Other: Optimized Shoulder Movement Program
A trained physical therapist will see the participant for a max of 6 visits over the 3 month intervention; for baseline instruction, and at 2, 4, 6, and 8 weeks to progress and check subject adherence before a final check-out and testing visit at 3 months. Participants will perform 3 assigned stretching motions a min of 2 sets of 10 reps each and will be instructed in active shoulder movements with a dose based on the subject's measured "activity count" at baseline and with enough duration to increase it by 10%. Exercise: 10-15 minutes 2x/day for 3 month duration. Participants will log their activity.
- Arm elevation. [ Time Frame: One year ]Arm elevation is a composite of shoulder (glenohumeral) and scapular motion and will be measured using goniometry and computer assisted kinematics. Glenohumeral elevation and external rotation motions are the main focus.
- Disability of the Arm, Shoulder, and Hand (DASH) questionnaire [ Time Frame: One year ]The DASH is an established, standardized measure used to characterize pain and disability in the upper extremity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162212
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63108|
|Principal Investigator:||Michael J Mueller, PT, PHD||Washington University School of Medicine|