interACTION: A Portable Joint Function Monitoring and Training System to Supplement Home Exercise Programs Following Anterior Cruciate Ligament Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Pittsburgh
- Locations
- 1
- Primary Endpoint
- Value evaluated by the ratio of patient outcomes to costs of rehabilitation
Study Overview
Brief Summary
The purpose of this study is to ascertain if home-based therapy with monitoring via telemedicine can overcome many barriers to compliance and improve rehabilitation following ACL reconstruction. Patients undergoing ACL Reconstruction will be followed for 6 weeks during their outpatient physical therapy treatment. Subjects will undergo weekly physical therapy or weekly physical therapy paired with InterACTION.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Between 15 to 30 years of age;
- •Have undergone ACL Reconstruction;
- •Being referred for post-operative outpatient physical therapy;
- •Agree to and able to perform pre-designed exercises that they would normally perform in a physical therapy program after ACL Reconstruction.
Exclusion Criteria
- •Patients undergoing concomitant meniscal repair or other surgical procedure requiring modification of post-operative physical therapy program;
- •Patients with BMI >40 at the time of surgery;
- •Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of physical therapy exercises;
Arms & Interventions
Physical Therapy with InterACTION
After ACL Reconstruction, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.
Intervention: interACTION (Device)
Physical Therapy
After ACL Reconstruction, subjects will undergo physical therapy 1 time per week
Intervention: Standard of Care Physical Therapy (Other)
Outcomes
Primary Outcomes
Value evaluated by the ratio of patient outcomes to costs of rehabilitation
Time Frame: 6 weeks
Value will be evaluated by the ratio of patient outcomes to costs of rehabilitation
Secondary Outcomes
No secondary outcomes reported
Investigators
James J. Irrgang
PhD, PT
University of Pittsburgh