Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05802368
Other study ID # RHPT/0021/0023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05617209 - In Vitro Correction of Thrombin Generation by Concizumab (Anti-TFPI) for Severe Hemophilia Patients
Completed NCT05039008 - Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy N/A
Recruiting NCT04398628 - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Completed NCT02546622 - ATHN 2: Factor Switching Study
Unknown status NCT02165592 - Assessment of Proprioceptive and Functional Characteristics in Patients With Hemophilia N/A
Terminated NCT02586012 - Weight-based Dosing in Hemophilia A Phase 2
Unknown status NCT02433782 - Myofascial Therapy in Patients With Hemophilic Arthropathy N/A
Completed NCT02165462 - Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy N/A
Completed NCT01232634 - Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles Phase 2
Completed NCT05104164 - Self-myofascial Release in Hemophilic Ankle Arthropathy N/A
Terminated NCT01191372 - First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients Phase 1
Completed NCT05173129 - Posture Analysis for Patients With Haemophilia N/A
Completed NCT03818529 - ATHN 8: Previously Untreated Patients (PUPs) Matter Study
Withdrawn NCT03996486 - Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia Phase 1
Completed NCT03842605 - Efficacy of Strength Training in Improving Elbow Range of Motion and Function in Adults With Hemophilia N/A
Completed NCT01708564 - A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B Phase 1
Completed NCT05549843 - Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle N/A
Recruiting NCT06010953 - SS109 and NovoSeven ® PK / PD Profile, and Preliminary Efficacy and Safety of SS109 on Demand Treatment Phase 1/Phase 2
Completed NCT05027230 - A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor Phase 1/Phase 2
Not yet recruiting NCT06014320 - Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease