NCT02750176

Brief Summary

A single arm design will be used to assess the feasibility and preliminary efficacy of a closed-chain rehabilitation protocol for patients with full thickness rotator cuff tears of the shoulder. Full thickness rotator cuff tears will be documented using MRI or ultrasound images. 30 participants will be recruited for this study. The rehabilitation protocol will include two stages: stage 1, physical therapy, and stage 2, gym program. Stage I will include a total number of session between 12 and 24. The number of session included in stage 2, will depend on the total number of session completed during stage 1. The total duration of both stages will 5 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Apr 2016

Typical duration for early_phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

April 18, 2016

Last Update Submit

October 23, 2018

Conditions

Full Thickness Rotator Cuff Tear

Keywords

RehabilitationClosed chain exercises

Outcome Measures

Primary Outcomes (3)

  • Feasibility - recruitment

    Recruit 65% of the patients with rotator cuff tears that come to the USC PT Associate clinic for physical therapy treatment or patients that are seen at the physician office and are referred for physical therapy treatment.

    End of the study (Stage 2): 5 months / approximately 24 weeks

  • Patient Specific Functional Scale (PSFS)

    End of the study (Stage 2): 5 months / approximately 24 weeks

  • Penn Shoulder Score (Penn)

    End of the study (Stage 2): 5 months / approximately 24 weeks

Secondary Outcomes (9)

  • Feasibility - retention

    End of the study (Stage 2): 5 months / approximately 24 weeks

  • Quick Disabilities of the Arm Shoulder Hand (QDASH) scale

    End of the study (Stage 2): 5 months / approximately 24 weeks

  • Global Rating of Change (GRoC) scale

    End of the study (Stage 2): 5 months / approximately 24 weeks

  • Numeric Pain Rating Scale (NPRS)

    End of the study (Stage 2): 5 months / approximately 24 weeks

  • American Shoulder and Elbow Surgeon Patient-report (ASES) scale

    End of the study (Stage 2): 5 months / approximately 24 weeks

  • +4 more secondary outcomes

Study Arms (1)

CERCT

EXPERIMENTAL

Closed chain exercises

Other: Closed chain exercises

Interventions

Closed chain exercisesOTHER

Closed-chain strengthening will be performed with the shoulder moving over a fixed hand. Resistance will be provided by body weight against gravity. To off-load and progress the amount of body-weight resistance, elastic bands will be used to support body weight using a exercise frame. Patients will perform 6 exercises.

CERCT

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Full-thickness rotator cuff tears - confirmed by ultrasound (US) or magnetic resonance imagining (MRI)
  • Symptomatic for \> 3 months
  • Reduction in shoulder function:
  • Patient satisfaction with use of their shoulder: ≤ 7/10 (10 = fully satisfied) OR Penn Function Subscale Score ≤ 40/60 (60 = full function)

You may not qualify if:

  • Physical therapy for current shoulder symptoms within last 3 months
  • Previous shoulder surgery on the involved shoulder
  • Cervical radiculopathy
  • Undergoing treatment for active cancer
  • Cardiovascular, pulmonary, neurological disease with physician limitations on exercise
  • Uncontrolled high blood pressure (\> systolic above 90, diastolic above 140)
  • Unstable shoulder - primary diagnosis
  • Unable to complete up to 5 months of treatment at the clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory

Los Angeles, California, 90089, United States

Location

Study Officials

  • Lori Michener, PT, ATC, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 25, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

US(1)