Rehabilitation With the Shoulder Pacemaker

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT06501859
Status
Enrolling By Invitation

Conditions

  • Shoulder Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard of care physical therapy — OTHER
    Standard rehabilitation protocol for 3 months.
  • Shoulder pacemaker with physical therapy — DEVICE
    Standardized rehabilitation protocol with utilization of the shoulder pacemaker device 3 times per week over a 3-month period.

Study Details

The investigators purpose of the proposed study is to use the FDA approved Shoulder Pacemaker device in patients undergoing reverse shoulder arthroplasty and study the functional outcomes compared to a standard post-operative rehabilitation program. The investigators hypothesize that use of the Shoulder Pacemaker reduce pain and will allow for improved range of motion and function in patients undergoing RSA. The findings of this research may very well improve function in RSA patients through a novel, non-invasive approach.

Key Dates

Start date
Aug 2, 2023
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of care physical therapy
    Control group and will not use the shoulder pacemaker, but will participate in a standardized physical therapy protocol for 3 months.
  • Experimental: Shoulder pacemaker with physical therapy
    Include a standardized physical therapy protocol with utilization of the Shoulder Pacemaker device 3 times per week over a 3-month period starting at 6 weeks post-operatively.

Primary Outcome Measure

American Shoulder and Elbow Surgeons score [ Time Frame: Pre-operatively ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Utah OrthopedicsSalt Lake CityUtah84108-

Find similar trials in Salt Lake City, UT

By research site
University of Utah Orthopedics· Salt Lake City, UT

Related Studies