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Rotator Cuff TearNCT00275366

Arm Robotics in Musculoskeletal Rehabilitation

A study testing Robotic Therapy in people with Rotator Cuff Tear, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Rotator Cuff Tear
What is being tested?
Robotic Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Jul 2005to Dec 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Age <39, or >65 years
  • Rotator cuff tear >5cm
  • Surgical finding of poor tendon tissue status
  • Open surgical procedure;
  • Rotator cuff revision procedure
  • Worker's compensation injury
  • History of neuro-motor disease of the upper extremities.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Maryland Health Care System, Baltimore

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Upper Extremity Robotics in Musculoskeletal Rehabilitation

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.

Read the 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.

Being tested
Robotic Therapy
Keywords
cuff, rotator, Rotator cuff
Medical subject headings
Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic TherapyDevice

Study groups in NCT00275366
Study groupRoleWhat they receive
1OtherNot described
Receives: Device: Robotic Therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2006 (estimated)
  2. Study startJul 2005
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00275366
Sponsor's protocol ID
B3827V
Status last verified
Mar 2008
First submitted
10 Jan 2006
Last updated
11 Mar 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Robotic Therapy in people with Rotator Cuff Tear, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2008.

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