NCT07713342

Brief Summary

Traction apophysitis of the medial epicondyle (MEC) is a common elbow injury in adolescent baseball players. The underlying pathology of the lesions associated with apophysitis seems to be due to repetitive traction stress via the medial ulnar collateral ligament (MUCL) to the skeletally immature MEC, as seen in young baseball players. Various types of morphological changes are observed at the MEC in baseball players, and fragmentation and hypertrophy have been commonly reported.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress14%
Jul 2026Oct 2026

First Submitted

Initial submission to the registry

July 2, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 20, 2026

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2026

Expected
Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

12 days

First QC Date

July 2, 2026

Last Update Submit

July 17, 2026

Conditions

Keywords

Medial Epicondyle ApophysitisVirtual Reality,strengthing exercise

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale

    pain assessment tool, the scale ranged from 0-10 (at which 0 indicate no pain and 10 indicate sever pain)

    at day 0

  • Visual Analogue Scale

    pain assessment scale, the scale ranged from 0-10 (at which 0 indicate no pain and 10 indicate sever pain)

    at day 90

Secondary Outcomes (4)

  • Range of Motion

    at day 0

  • Range of Motion

    at day 90

  • Range of Motion

    at day 0

  • Range of Motion

    at day 90

Study Arms (2)

Experimental: The Control Group

EXPERIMENTAL

Group (A)

Other: The Control Group

The Study Group

EXPERIMENTAL

Group (B)

Other: The Study Group

Interventions

All adolescents will receive 60 min. of the selected physical therapy program including strengthening the muscles of upper limb, stretching for elbow flexors and forearms pronators

Also known as: Group (A)
Experimental: The Control Group

all adolescents will receive selected physical therapy program for 30 min. containing strengthening the muscles of upper limb, stretching for elbow flexors and forearms pronators plus 30 of virtual reality training

Also known as: Group (B)
The Study Group

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cases diagnosed with medial epicondyle apophysitis.
  • Cases participated in this study will from both sexes.
  • Cases receiving standard treatment protocol.
  • Cases with a disease duration of more than four months.

You may not qualify if:

  • Cases with resent fractures in affected upper limb.
  • Cases diagnosis of any neurological disease or musculoskeletal disease affecting upper extremity functional ability.
  • Uncooperative cases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nehad A Abo-zaid

Asyut, Egypt

Location

Related Publications (7)

  • Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014.

    PMID: 24681826BACKGROUND
  • Thomas S, Fazakarley L, Thomas PW, Collyer S, Brenton S, Perring S, Scott R, Thomas F, Thomas C, Jones K, Hickson J, Hillier C. Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis. BMJ Open. 2017 Sep 27;7(9):e016966. doi: 10.1136/bmjopen-2017-016966.

    PMID: 28954791BACKGROUND
  • McPhail SM, O'Hara M, Gane E, Tonks P, Bullock-Saxton J, Kuys SS. Nintendo Wii Fit as an adjunct to physiotherapy following lower limb fractures: preliminary feasibility, safety and sample size considerations. Physiotherapy. 2016 Jun;102(2):217-20. doi: 10.1016/j.physio.2015.04.006. Epub 2015 Jun 17.

    PMID: 26209909BACKGROUND
  • Shousha TM, Abo-Zaid NA, Hamada HA, Abdelsamee MYA, Behiry MA. Virtual reality versus Biodex training in adolescents with chronic ankle instability: a randomized controlled trial. Arch Med Sci. 2021 Mar 18;19(4):1059-1068. doi: 10.5114/aoms/134635. eCollection 2023.

    PMID: 37560731BACKGROUND
  • Benzing V, Schmidt M. Exergaming for Children and Adolescents: Strengths, Weaknesses, Opportunities and Threats. J Clin Med. 2018 Nov 8;7(11):422. doi: 10.3390/jcm7110422.

  • Mouhamed HA, Abo-Zaid NA, Khalifa HA, Ali ME, Elserty NS, Behiry MA, Heneidy WE. Efficacy of virtual reality on balance impairment in ataxic cerebral palsy children: randomized controlled trial. Eur J Phys Rehabil Med. 2024 Dec;60(6):949-955. doi: 10.23736/S1973-9087.24.08617-9. Epub 2024 Oct 23.

  • Abo-Zaid, N.A., Helmy, N.A., Elsayed, N.I., & Mohammed, A.H. (2021). Wii Sport versus task-oriented training on gait in unilateral cerebral palsy: A randomized controlled trial. Journal of Human Sport and Exercise, 16(2proc), S522-S531. doi:https://doi.org/10.14198/jhse.2021.16.Proc2.36

    RESULT

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Nehad A Abo-zaid, Assistant Professor

    South Valley University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nehad A Abo-zaid, Assistant Professor

CONTACT

Ola A KamalLecturer, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Duple blinded (Outcomes Assessor, patients) Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group 1 (control group) and Group 2 (virtual reality group),
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: G 1 (control) received traditional physical therapy program for 60 min. G 2 (study) received traditional physical therapy program for 30 min. and virtual reality for 30 min. all groups treated for 3 successive months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 20, 2026

Study Start

July 20, 2026

Primary Completion

August 1, 2026

Study Completion (Estimated)

October 20, 2026

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations