Clinical trial NCT05802368: Hemophilic Knee Arthropathy Virtual Reality
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Knee Arthropathy
Lead sponsor: Qassim University
Sponsor class: OTHER
Collaborators: name: Cairo University
name: Prince Sattam Bin Abdulaziz University
First posted: 2023-04-06
Enrollment: 56
Sex: MALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait Analysis
timeFrame: at first week
measure: Gait Analysis
timeFrame: after 12 weeks
Secondary outcomes:
measure: Functional ability assessment
timeFrame: at first week
measure: Functional ability assessment
timeFrame: after 12 weeks
measure: Physical activity level assessment
timeFrame: at first week
measure: Physical activity level assessment
timeFrame: after 12 weeks
Other outcomes:
Locations:
city: Al-Kharj
country: Saudi Arabia
facility: King Khalid Hospital
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Alshimaa Azab, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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):227-32. doi: 10.1159/000442752. Epub 2015 Nov 26.