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

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ClinicalTrials.gov Identifier: NCT02775188
Recruitment Status : Withdrawn (Because of technical and feasibility issues with InterACTION, the study to investigate the system for individuals following ACL reconstruction was terminated.)
First Posted : May 17, 2016
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
James J. Irrgang, 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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Device: interACTION Other: Standard of Care Physical Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: interACTION: A Portable Joint Function Monitoring and Training System to Supplement Home Exercise Programs Following Anterior Cruciate Ligament Reconstruction
Study Start Date : July 2016
Actual Primary Completion Date : January 19, 2018
Actual Study Completion Date : January 19, 2018


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
Physical Therapy
After ACL Reconstruction, subjects will undergo physical therapy 1 time per week
Other: Standard of Care Physical Therapy



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775188


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh

Responsible Party: James J. Irrgang, PhD, PT, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02775188     History of Changes
Other Study ID Numbers: PRO16020108
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018