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Arm Robotics in Musculoskeletal Rehabilitation

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00275366
First received: January 10, 2006
Last updated: March 10, 2008
Last verified: March 2008
  Purpose

This purpose of this study is to determine the outcomes of the first-known application of robotic therapy in the rehabilitation following rotator cuff repair, using a novel vertical oblique robotic module.


Condition Intervention
Rotator Cuff Tear
Device: Robotic Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Upper Extremity Robotics in Musculoskeletal Rehabilitation

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 20
Study Start Date: July 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Device: Robotic Therapy

Detailed Description:

Musculoskeletal conditions are a leading cause of disability in the United States accounting for more than 130 million patient visits to healthcare providers annually. Rotator cuff tears are one of the most common causes of pain and disability of the upper extremity. Impaired motor control of the shoulder girdle muscles with concomitant instability often exists prior to any surgical procedure. Re-tears and/or attenuation after rotator cuff repairs occur relatively frequently and may compromise the functional result. Loading of the UE during rehabilitation, thus the repair site, following the surgical procedure has been implicated in these complications Conventional shoulder rehabilitation protocols with the human-human interface do not possess the ability to systematically quantify dosing and progression for patients in the subacute stages thus, potentially overloading the repair site. No evidence-based research exists comparing outcomes of specific rehabilitative training protocols in these post-surgical patients. Consensus statements conclude, �a need for clinical trials, and validated outcome measures is essential�.

Advances in robotics technology offer unprecedented opportunities to improve rehabilitation pathways, but until now these technologies have focused primarily on neurological disease. The MIT Newman Laboratory for Biomechanics and Human Rehabilitation upper extremity (UE) robot is an impedance controlled, back-drivable, oblique-vertical vertical robot that has been designed such that it can safely exert controlled, graded forces to move or guide a limb, functioning in passive, active-assistive, active and resistive modes, providing objective data on the motion. A major advantage is its capacity for real-time, graded changes based on patient input, providing stability against random perturbations, increasing or withdrawing assistance and allowing for dose-specific treatment. The vertical robot device has been shown to be safe and well tolerated without any adverse effects such as shoulder pain.

Goal-directed, quantifiable rehabilitation protocols for redevelopment of function through improved range of motion, strength and motor control are lacking in patients with musculoskeletal impairments. The successful robotic-assisted rehabilitation of the acute and chronic, severe impairment provides an impetus for applying this technology to UE musculoskeletal impairments. The ability to objectively control and measure the dosing and progression during the rehabilitation process is a valuable tool in the advancement of evidence�based rehabilitation interventions The proposed pilot clinical trial will determine if 8-weeks of robotic rehabilitation improves the rate and quality of recovery of range of motion, strength, and function following rotator cuff repair compared with a conventional physical therapy rehabilitation protocol.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. aged 40-65 years
  2. Surgeon referral with medical clearance;
  3. <3 weeks post-arthroscopic rotator cuff repair
  4. Rotator cuff tear size <5cm;
  5. Surgeon reported good tendon tissue health status
  6. Adequate cognition and language skills to provide informed consent and participate in robotics training and/or robotics testing.

Exclusion Criteria:

  1. Age <39, or >65 years
  2. Rotator cuff tear >5cm
  3. Surgical finding of poor tendon tissue status
  4. Open surgical procedure;
  5. Rotator cuff revision procedure
  6. Worker's compensation injury
  7. History of neuro-motor disease of the upper extremities.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275366

Locations
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Investigators
Principal Investigator: Margaret Finley, PhD VA Maryland Health Care System, Baltimore
  More Information

No publications provided

Responsible Party: Finley, Margaret - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00275366     History of Changes
Other Study ID Numbers: B3827V
Study First Received: January 10, 2006
Last Updated: March 10, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
cuff, rotator
Rotator cuff

ClinicalTrials.gov processed this record on November 25, 2014