Hemophilic Knee Arthropathy Virtual Reality

Hemophilia Clinical Trial

— hemophilia  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05802368
• Other study ID #: RHPT/0021/0023
• Status: Completed
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: January 23, 2023

Study information

• Verified date: March 2023
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 23, 2023
• Est. primary completion date: October 16, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 10 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia
• Joint Diseases
• Knee Arthropathy

Intervention

Other:
• virtual reality group
a 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy.
• exercise group
Traditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least

Locations

Country	Name	City	State
Saudi Arabia	King Khalid Hospital	Al-Kharj	Riyadh

Sponsors (3)

Lead Sponsor	Collaborator
Maged Basha	Cairo University, Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

Falk B, Portal S, Tiktinsky R, Weinstein Y, Constantini N, Martinowitz U. Anaerobic power and muscle strength in young hemophilia patients. Med Sci Sports Exerc. 2000 Jan;32(1):52-7. doi: 10.1097/00005768-200001000-00009. — View Citation

Hilberg T, Herbsleb M, Gabriel HH, Jeschke D, Schramm W. Proprioception and isometric muscular strength in haemophilic subjects. Haemophilia. 2001 Nov;7(6):582-8. doi: 10.1046/j.1365-2516.2001.00563.x. — View Citation

Regaieg S, Charfi N, Yaich S, Damak J, Abid M. The Reliability and Concurrent Validity of a Modified Version of the International Physical Activity Questionnaire for Adolescents (IPAQ-A) in Tunisian Overweight and Obese Youths. Med Princ Pract. 2016;25(3) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Analysis	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
Primary	Gait Analysis	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	Functional ability assessment	The 6-minute walk test was used to assess functional abilities.	at first week
Secondary	Functional ability assessment	The 6-minute walk test was used to assess functional abilities.	after 12 weeks
Secondary	Physical activity level assessment	The Adolescents' Physical Activity Questionnaire (PAQ-A) in Arabic edition was used to measure the physical activity level assessment.	at first week
Secondary	Physical activity level assessment	The Adolescents' Physical Activity Questionnaire (PAQ-A) in Arabic edition was used to measure the physical activity level assessment.	after 12 weeks