NCT07054814

Brief Summary

The purpose of this study is to investigate the effectiveness of integrating game based virtual reality on muscle strength ,balance , range of motion ,functional mobility after foot tendon repair and to compare it with standard rehabilitation methods.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

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

First Submitted

Initial submission to the registry

June 28, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

July 3, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

July 8, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 28, 2025

Last Update Submit

June 28, 2025

Conditions

Keywords

Achilles tendon repair

Outcome Measures

Primary Outcomes (1)

  • Balance

    Biodex balance system for balance assessment

    At base line and 6 weeks

Secondary Outcomes (5)

  • Symptom relief

    At base line and at 6 and 12 week

  • Range of motion

    At baseline and at 6 weeks and 12 weeks

  • Functional ability

    At base line and at 6 weeks and at 12 weeks

  • Symmetry

    At base line and week 6 and wee12

  • Muscle strength

    At baseline and week 6 and 12

Study Arms (2)

gemes based virtual reality

EXPERIMENTAL

This group includes 30 patients who will receive game based virtual reality exercise using samsung Gear VR plus accelerate functional rehab programe physical therapy 3 times per week for 30 minutes for 12 weeks starting once patient able to do partial or complete weight bearing around (4-6 weeks post operative).

Device: samsung gear VR googleOther: Traditional theraapy

accelerated functional rehab protocol

ACTIVE COMPARATOR

This group includes 30 patients who will receive accelerated functional rehab programe only for 3 sessions per week .

Other: Traditional theraapy

Interventions

do some of games based VR exercise Headmaster 3.0 Dream Match Tennis Beat Saber (PSVR) Knockout League Hoops Richie's Plank Experience Pong It VR Egg Time VR Sparc VR plus accelerated functional rehab protocol General Principles: Goal: Promote tendon healing while minimizing stiffness, muscle atrophy, and encouraging a faster return to full function. Approach: Early controlled mobilization, gradual loading based on patient tolerance (without excessive pain or swelling). Important: Supervised by an orthopedic surgeon and a physical therapist. Device: Start with a walker boot or splint keeping the ankle plantarflexed. Phases of Rehabilitation:

Also known as: traditional protocol of accelerated functional rehab
gemes based virtual reality

General Principles: accelerated functional rehab protocol Goal: Promote tendon healing while minimizing stiffness, muscle atrophy, and encouraging a faster return to full function. Approach: Early controlled mobilization, gradual loading based on patient tolerance (without excessive pain or swelling). Important: Supervised by an orthopedic surgeon and a physical therapist. Device: Start with a walker boot or splint keeping the ankle plantarflexed. Phases of Rehabilitation:

accelerated functional rehab protocolgemes based virtual reality

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18 to 26 years. Patients undergoing or who have undergone unilateral achilles tendon surgical repair .
  • weeks post operative ,partial to full weight bearing Patients willing to participate in rehabilitation protocol.

You may not qualify if:

  • o Patients with severe diseases or impaired control of gait patterns.
  • Patients with high scores in anxiety or stress tests, indicating significant psychological distress.
  • Patients who report fatigue or are medically unstable.
  • Patients who have any other orthopedic or neurological problems .
  • Patients who have renal, cardiac,hepatic edema
  • Patients who have gout,plantar fasciitis,fracture dislocation or any types of foot ulcer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Police Hospital Ministry of Interior

Cairo, +2, Egypt

Location

Study Officials

  • Mohamed AR Osman, MSC

    Police hospital ,cairo ,egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed AR osman, MSC

CONTACT

mohamed AR osman, MSC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (participant )
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 28, 2025

First Posted

July 8, 2025

Study Start

July 3, 2025

Primary Completion

October 15, 2025

Study Completion

November 15, 2025

Last Updated

July 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations