Hemophilic Knee Arthropathy Virtual Reality (hemophilia)

March 27, 2023 updated by: Maged Basha

Adolescents With Hemophilic Knee Arthropathy Can Improve Their Gait Characteristics, Functional Ability, and Physical Activity Level Through Kinect-based Virtual Reality: a Randomized Clinical Trial

This study intended to examine the effect of a physical rehabilitation program incorporating Kinect-based virtual reality on gait characteristics, functional ability, and physical activity level in adolescents with hemophilic knee arthropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The usage of virtual reality in clinical practice as an alternative for conventional procedures has recently sparked the interest of health professionals. Virtual reality is a type of computer technology that provides simulated sensory feedback to allow children to participate in activities and events that are comparable to those they could face in real life. It can be used therapeutically to enhance strength, range of motion, coordination, mental concentration, problem solving, decision making, balance, and gait.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Riyadh
      • Al-Kharj, Riyadh, Saudi Arabia
        • King Khalid Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • moderate hemophilia
  • bilateral involvement of the knee joint
  • medically stable and received their factor replacement therapy
  • free from contracture or congenital anomalies
  • didn't have persisting, disabling pain.

Exclusion Criteria:

  • recent bleeding episodes
  • severe radiological abnormalities such as bone erosions, degeneration, bone ankylosis, or joint subluxation
  • engagement in a regular exercise program in the past six months
  • the unwillingness to stick to the training schedule

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
a 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy.
Other: virtual reality group
a 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy.
Other Names:
  • Kinect based virtual reality combined with physical exercises
Other: exercise group
Traditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least
Other Names:
  • physical exercises alone
Experimental: control group
Traditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least
Other: exercise group
Traditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least
Other Names:
  • physical exercises alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Analysis
Time Frame: at first week
Each participant was instructed to walk bare feet with a comfortable, self-selected speed along a 10-meter walkway while the trajectories of reflective markers and forces were respectively recorded through 12 optoelectronic cameras (Vicon Motion Systems Ltd., Oxford, UK) with a 120-Hz sampling rate and two force plates at 1000 Hz.
at first week
Gait Analysis
Time Frame: after 12 weeks
Each participant was instructed to walk bare feet with a comfortable, self-selected speed along a 10-meter walkway while the trajectories of reflective markers and forces were respectively recorded through 12 optoelectronic cameras (Vicon Motion Systems Ltd., Oxford, UK) with a 120-Hz sampling rate and two force plates at 1000 Hz.
after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional ability assessment
Time Frame: at first week
The 6-minute walk test was used to assess functional abilities.
at first week
Functional ability assessment
Time Frame: after 12 weeks
The 6-minute walk test was used to assess functional abilities.
after 12 weeks
Physical activity level assessment
Time Frame: at first week
The Adolescents' Physical Activity Questionnaire (PAQ-A) in Arabic edition was used to measure the physical activity level assessment.
at first week
Physical activity level assessment
Time Frame: after 12 weeks
The Adolescents' Physical Activity Questionnaire (PAQ-A) in Arabic edition was used to measure the physical activity level assessment.
after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maged Basha

Collaborators

Cairo University
Prince Sattam Bin Abdulaziz University

Investigators

  • Principal Investigator: Alshimaa Azab, PhD, Prince Sattam Bin Abdulaziz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2021

Primary Completion (Actual)

October 16, 2022

Study Completion (Actual)

January 23, 2023

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHPT/0021/0023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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