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

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 Overview

• Status: Withdrawn
• Conditions: Anterior Cruciate Ligament Reconstruction
• Intervention / Treatment: Device: interACTION; Other: Standard of Care Physical Therapy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Physical Therapy with InterACTION; After ACL Reconstruction, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.	Device: interACTION
OTHER: Physical Therapy; After ACL Reconstruction, subjects will undergo physical therapy 1 time per week	Other: Standard of Care Physical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): January 19, 2018
• Study Completion (ACTUAL): January 19, 2018

Study Registration Dates

• First Submitted: May 14, 2016
• First Submitted That Met QC Criteria: May 14, 2016
• First Posted (ESTIMATE): May 17, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PRO16020108