The Effect of Cross-Education on Shoulder Arthroscopy

NCT04470570 | Completed

• 1 other identifier: STUDY00000737
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effectiveness of a strength training protocol on the uninjured upper extremity either alone or with the addition of blood flow restriction (BFR) training on subjects who have undergone shoulder arthroscopy.

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries; Rotator Cuff Repair

Keywords

biceps tenodesis; Cross-Education; Blood-Flow Restriction Training

Outcome Measures

Primary Outcomes (1)

• Change in strength of the shoulder at 6 weeks and 12 weeks

  Strength of the shoulder will be assessed via hand-held dynamometer

  pre-operative visit, 6 week post-operative visit, 12-week post-operative visit

Study Arms (3)

Control Group

NO INTERVENTION

This group will undergo a standardized rehabilitation protocol of the involved shoulder only.

Cross-Education Group

EXPERIMENTAL

This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side.

Other: Cross-Education

Cross-Education + Blood-Flow Restriction Group

EXPERIMENTAL

This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side with blood-flow restriction simultaneously.

Other: Cross-Education; Other: Blood-Flow Restriction Training

Interventions

Cross-Education OTHER

1\) Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.

Cross-Education + Blood-Flow Restriction Group; Cross-Education Group

Blood-Flow Restriction Training OTHER

1\) Blood Flow Restriction: A type of resistance training using a blood-pressure like cuff that partially occludes venous blood flow to induce various neurohormonal effects and allows strength gains to be achieved at very low loads of resistance.

Cross-Education + Blood-Flow Restriction Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Diagnosed with rotator cuff injury
• Scheduled for rotator cuff surgery via shoulder arthroscopy

You may not qualify if:

• Less than 18 years old
• History of previous contra-lateral surgery or injury
• Previous ipsi-lateral upper extremity surgery
• History of shoulder osteoarthritis

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Kerlan-Jobe Institute

Los Angeles, California, 90045, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Michael B Banffy, MD

  Cedars-Sinai Kerlan-Jobe Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Orthopedic Sports Medicine Fellowship

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 14, 2020
• Study Start: July 13, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 6 months after the study has been published.

Locations

US (1)