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Completed

NCT Number: NCT05802368

Hemophilic Knee Arthropathy Virtual Reality

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.

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Key information

Age range

10 year–14 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

King Khalid Hospital

Al Kharj, Riyadh Region, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Group

Other

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

Exercise group

Other

Traditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least

Other names: physical exercises alone

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Functional ability assessment

    Time frame: at first week

    The 6-minute walk test was used to assess functional abilities.

  2. Functional ability assessment

    Time frame: after 12 weeks

    The 6-minute walk test was used to assess functional abilities.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Maged Basha

Other

Collaborators

  • Cairo University
  • Prince Sattam Bin Abdulaziz University

Registry information

Official study title

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

Acronym: hemophilia

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 6, 2023
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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