NCT00275366

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 11, 2008

Status Verified

March 1, 2008

Enrollment Period

2.4 years

First QC Date

January 10, 2006

Last Update Submit

March 10, 2008

Conditions

Rotator Cuff Tear

Keywords

cuff, rotatorRotator cuff

Study Arms (1)

1

OTHER
Device: Robotic Therapy

Interventions

Robotic TherapyDEVICE
1

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Margaret Finley, PhD

    VA Maryland Health Care System, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 11, 2006

Study Start

July 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 11, 2008

Record last verified: 2008-03

Locations

US(1)