Clinical Trials Directory

Trials / Completed

CompletedNCT04470570

The Effect of Cross-Education on Shoulder Arthroscopy

The Effects of Cross-Education and Blood Flow Restriction Study on Patients Undergoing Shoulder Arthroscopy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Cedars-Sinai Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

The purpose of this study is to examine the effectiveness of a strength training protocol on the uninjured limb either alone or with the addition of blood flow restriction (BFR) training on the status of the injured limb post shoulder arthroscopy. Patients will be randomized into one of three standardized physical therapy (PT) groups after shoulder arthroscopy: Control group (CON), Strength Training on the uninvolved shoulder (STR), strength training with the BFR on the uninvolved shoulder (BFR). All three patient groups will follow a standardized PT rehab protocol that is usual standard of care on the involved shoulder. The STR and BFR group will follow a typical standard of care rehab protocol to the uninvolved side to investigate the potential effects of cross-education. Isometric strength will be assessed utilizing handheld dynamometry (HHD) at Kerlan-Jobe during their regularly scheduled pre-operative and follow-up visits. Patients age 18 and older undergoing shoulder arthroscopy for rotator cuff repair and/or biceps tenodesis. The study includes 3 visits which are standard of care pre-operative and post-operative visits. The duration of the study will be 14 weeks. 2 weeks to allow for a pre-op baseline strength assessment and 12 weeks post-op for the final assessment during the patients routine follow-up visit. Physical Therapy will be standardized for all three groups in terms of frequency and rehabilitation protocol. The only exercises that will be added will be to the intervention groups on the uninvolved side. Patients will present to physical therapy 2-3 times/week during the duration of the study regardless of their group allocation.

Conditions

Interventions

TypeNameDescription
OTHERCross-Education1\) Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.
OTHERBlood-Flow Restriction Training1\) 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.

Timeline

Start date
2020-07-13
Primary completion
2020-09-30
Completion
2020-10-30
First posted
2020-07-14
Last updated
2024-02-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04470570. Inclusion in this directory is not an endorsement.