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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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University of Pittsburgh

Status

Withdrawn

Conditions

Anterior Cruciate Ligament Reconstruction

Treatments

Other: Standard of Care Physical Therapy
Device: interACTION

Study type

Interventional

Funder types

Other

Identifiers

NCT02775188
PRO16020108

Details and patient eligibility

About

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.

Sex

All

Ages

15 to 30 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Physical Therapy with InterACTION
Experimental group
Description:
After ACL Reconstruction, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.
Treatment:
Device: interACTION
Physical Therapy
Other group
Description:
After ACL Reconstruction, subjects will undergo physical therapy 1 time per week
Treatment:
Other: Standard of Care Physical Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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