Hemophilic Knee Arthropathy Virtual Reality

NCT05802368 | Completed

• 1 other identifier: RHPT/0021/0023
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia; Knee Arthropathy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Functional ability assessment

  at first week

• Functional ability assessment

  after 12 weeks

• Physical activity level assessment

  at first week

• Physical activity level assessment

  after 12 weeks

Study Arms (2)

study group

EXPERIMENTAL

a 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy.

Other: virtual reality group; Other: exercise group

control group

EXPERIMENTAL

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

Other: exercise group

Interventions

virtual reality group OTHER

a 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy.

Also known as: Kinect based virtual reality combined with physical exercises

study group

exercise group OTHER

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

Also known as: physical exercises alone

control group; study group

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maged Basha: lead
• Cairo University: collaborator
• Prince Sattam Bin Abdulaziz University: collaborator

Study Sites (1)

King Khalid Hospital

Al Kharj, Riyadh Region, Saudi Arabia

Location

Related Publications (3)

• 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.

  PMID: 11851757 BACKGROUND

• 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.

  PMID: 10647529 BACKGROUND

• 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.

  PMID: 26613579 RESULT

MeSH Terms

Conditions

Hemophilia A

Interventions

Exercise

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alshimaa Azab, PhD

  Prince Sattam Bin Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, College of Medical Rehabilitation, Qassim University

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 6, 2023
• Study Start: November 10, 2021
• Primary Completion: October 16, 2022
• Study Completion: January 23, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

SA (1)