Effect of Virtual Reality on Upper Extremity Function Post-operative Rotator Cuff Repair

NCT06246305 | Unknown

• 1 other identifier: VR on rotator cuff repair
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the effect and the impact of performing virtual reality intervention on upper extremity function in patients with post-operative rotator cuff repair. The main question that it aims to answer is: Does the application of virtual reality intervention improves upper extremity function in patients with post-operative rotator cuff repair. Participants will be randomized into 2 groups: the control group receiving conventional physical therapy intervention and the experimental group receiving the virtual reality intervention.

Conditions

Rotator Cuff Impingement Syndrome; Rotator Cuff Tears; Rotator Cuff Injuries

Keywords

rotator cuff repair; post-operative; upper extremity; function

Outcome Measures

Primary Outcomes (1)

• Shoulder function with disabilities of arm, shoulder and hand

  in numbers, it ranges from 0 to 100 with 0 being the lowest and 100 the highest. The higher the score means the better outcome

  Measured at baseline, after 6 weeks, and after 12 weeks

Secondary Outcomes (3)

• The Numerical Pain Intensity Rating Scale

  Measured at baseline, after 6 weeks, and after 12 weeks

• Active and passive range of motion using goniometer

  Measured at baseline, after 6 weeks, and after 12 weeks

• Isometric muscle test by Handheld Dynamometer

  Measured at baseline, after 6 weeks, and after 12 weeks

Study Arms (2)

Conventional physical therapy

ACTIVE COMPARATOR

The conventional therapy rehabilitation program is divided into three phases: on-brace, off-brace, and active mobilization. The on-brace phase (post-op 0-6 weeks) mainly consists of low-intensity whole-body exercises with shoulder girdle, elbow, and hand mobilization exercises on the affected side. In this phase, exercises are done of three sets with 10 repetitions per day. The off-brace phase (post-op 6-9 weeks) consists of passive shoulder ROM exercises using an exercise stick and an early scapular stabilization exercise. The active mobilization phase (post-op 9-12 weeks) consists of both active and passive shoulder ROM , strengthening exercise with progressive resistance using TheraBand, and scapular stabilization exercises. During the off-brace and active mobilization phases, exercises are done of 3-5 sets of exercises with 10 repetitions per day.

Other: conventional physical therapy training

Virtual reality (VR)

EXPERIMENTAL

During the on-brace phase(0-6 weeks), participants in this group will use the program as performed in the control group. During the off-brace (6-9 weeks post-op) and active mobilization phases (9-12 weeks post-op), participants will use the Virtual Reality machine. This program includes warming and cooling periods with posterior, anterior and inferior capsule stretching and pectoral muscle stretching. Exercise training includes bilateral shoulder elevation, boxing, bowling and tennis games accompanied by avatar. Resistance training is progressed in the active mobilization phase using TheraBand.

Device: Virtual Reality (VR) training

Interventions

conventional physical therapy training OTHER

conventional therapy rehabilitation program is divided into three phases: on-brace, off-brace, and active mobilization. The on-brace phase (post-op 0-6 weeks) mainly consists of low-intensity whole-body exercises with shoulder girdle, elbow, and hand mobilization exercises on the affected side. The off-brace phase (post-op 6-9 weeks) consists of passive shoulder ROM exercises using an exercise stick and an early scapular stabilization exercise. The active mobilization phase (post-op 9-12 weeks) consists of both active and passive shoulder ROM , strengthening exercise with progressive resistance, and scapular stabilization exercises. The intervention is done 3 times per week for 12 weeks.

Conventional physical therapy

Virtual Reality (VR) training DEVICE

During the on-brace phase (0-6 weeks), participants in this group will use the program as performed in the control group. During the off-brace (6-9 weeks post-op) and active mobilization phases (9-12 weeks post-op), participants will use the Virtual Reality machine. this program involves warming up and down stretching exercises and exercise training that includes bilateral shoulder elevation, boxing, bowling and tennis games accompanied by avatar. The intervention is done 3 times per week for 12 weeks.

Virtual reality (VR)

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years old and younger than 70 years old, and referred by the Adult Orthopedic Department with arthroscopic RC repair of a non-retracted isolated full-thickness supraspinatus tear with maximum 5 days post operation.
• Poor response to initial non-operative treatment.

You may not qualify if:

• Large-sized RC tears (3-5 cm),
• Massive or irreparable RC tears,
• Anteroinferior labral (Bankart) or superior labrum anterior to posterior lesions,
• Severe glenohumeral osteoarthritis,
• Adhesive capsulitis, or
• Previous surgery on the affected shoulder
• Re-tears of the RC.
• Indication for revision RCR
• Severe neurological deficits
• Infection in the affected shoulder
• Blindness and/or illiteracy

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed ElMelhat [aelmelhat]

Cairo, Egypt

RECRUITING

Related Publications (2)

• Gutierrez-Espinoza H, Araya-Quintanilla F, Pinto-Concha S, Zavala-Gonzalez J, Gana-Hervias G, Cavero-Redondo I, Alvarez-Bueno C. Effectiveness of supervised early exercise program in patients with arthroscopic rotator cuff repair: Study protocol clinical trial. Medicine (Baltimore). 2020 Jan;99(4):e18846. doi: 10.1097/MD.0000000000018846.

  PMID: 31977882 BACKGROUND

• Correia FD, Molinos M, Luis S, Carvalho D, Carvalho C, Costa P, Seabra R, Francisco G, Bento V, Lains J. Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):237-249. doi: 10.1097/PHM.0000000000001780.

  PMID: 33935152 BACKGROUND

Related Links

• Post-operative rehabilitation using a digital healthcare system in patients who had undergone rotator cuff repair: protocol for a single-center randomized controlled trial
• A randomized controlled trial of postoperative rehabilitation using digital healthcare system after rotator cuff repair
• Comparison of virtual reality exergaming and home exercise programs in patients with subacromial impingement syndrome and scapular dyskinesis: Short term effect
• The Effects of Virtual Reality Exergaming on Pain, Functionality and Acromiohumeral Distance in Shoulder Impingement Syndrome Patients: A Randomized Controlled Study

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries

Study Officials

• Ahmed El Melhat, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed El Melhat, PhD

CONTACT

01112595022; ahmed.elmelhat@cu.edu.eg

Aseel El kawam, DPT

CONTACT

70656958; aseelkawam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants will be randomized into one of the 2 groups: the control group receiving the conventional physical therapy intervention or to the experimental group receiving virtual reality intervention

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 7, 2024
• Study Start: January 28, 2024
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-01

Locations

EG (1)