interACTION: A Portable Joint Function Monitoring and Training System to Supplement Home Exercise Programs Following Anterior Cruciate Ligament Reconstruction

Not Applicable

Withdrawn

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Device: interACTION; Other: Standard of Care Physical Therapy

• Registration Number: NCT02775188
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-14
• Study First Submitted QC: 2016-05-14
• Study First Posted: 2016-05-17
• Study Start: 2016-07
• Primary Completion: 2018-01-19
• Study Completion: 2018-01-19
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Between 15 to 30 years of age;
2. Have undergone ACL Reconstruction;
3. Being referred for post-operative outpatient physical therapy;
4. Agree to and able to perform pre-designed exercises that they would normally perform in a physical therapy program after ACL Reconstruction.

Exclusion Criteria

1. Patients undergoing concomitant meniscal repair or other surgical procedure requiring modification of post-operative physical therapy program;
2. Patients with BMI >40 at the time of surgery;
3. 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Therapy with InterACTION	interACTION	After ACL Reconstruction, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.
Physical Therapy	Standard of Care Physical Therapy	After ACL Reconstruction, subjects will undergo physical therapy 1 time per week

Primary Outcome Measures

Name	Time	Method
Value evaluated by the ratio of patient outcomes to costs of rehabilitation	6 weeks	Value will be evaluated by the ratio of patient outcomes to costs of rehabilitation

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States