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

NCT02775188 | Withdrawn

• 1 other identifier: PRO16020108
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (1)

• Value evaluated by the ratio of patient outcomes to costs of rehabilitation

  Value will be evaluated by the ratio of patient outcomes to costs of rehabilitation

  6 weeks

Study Arms (2)

Physical Therapy with InterACTION

EXPERIMENTAL

After ACL Reconstruction, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.

Device: interACTION

Physical Therapy

OTHER

After ACL Reconstruction, subjects will undergo physical therapy 1 time per week

Other: Standard of Care Physical Therapy

Interventions

interACTION DEVICE

Physical Therapy with InterACTION

Standard of Care Physical Therapy OTHER

Physical Therapy

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

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: PhD, PT

Study Record Dates

• First Submitted: May 14, 2016
• First Posted: May 17, 2016
• Study Start: July 1, 2016
• Primary Completion: January 19, 2018
• Study Completion: January 19, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

US (1)