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Hemophilic Knee Arthropathy Virtual Reality (hemophilia)

Primary Purpose

Hemophilia, Knee Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
virtual reality group
exercise group
Sponsored by
Maged Basha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia

Eligibility Criteria

10 Years - 14 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • King Khalid Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

study group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Functional ability assessment
The 6-minute walk test was used to assess functional abilities.
Functional ability assessment
The 6-minute walk test was used to assess functional abilities.
Physical activity level assessment
The Adolescents' Physical Activity Questionnaire (PAQ-A) in Arabic edition was used to measure the physical activity level assessment.
Physical activity level assessment
The Adolescents' Physical Activity Questionnaire (PAQ-A) in Arabic edition was used to measure the physical activity level assessment.

Full Information

First Posted
March 27, 2023
Last Updated
March 27, 2023
Sponsor
Maged Basha
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT05802368
Brief Title
Hemophilic Knee Arthropathy Virtual Reality
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
October 16, 2022 (Actual)
Study Completion Date
January 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maged Basha
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia, Knee Arthropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
a 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy.
Arm Title
control group
Arm Type
Experimental
Arm Description
Traditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least
Intervention Type
Other
Intervention Name(s)
virtual reality group
Other Intervention Name(s)
Kinect based virtual reality combined with physical exercises
Intervention Description
a 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy.
Intervention Type
Other
Intervention Name(s)
exercise group
Other Intervention Name(s)
physical exercises alone
Intervention Description
Traditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least
Primary Outcome Measure Information:
Title
Gait Analysis
Description
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.
Time Frame
at first week
Title
Gait Analysis
Description
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.
Time Frame
after 12 weeks
Secondary Outcome Measure Information:
Title
Functional ability assessment
Description
The 6-minute walk test was used to assess functional abilities.
Time Frame
at first week
Title
Functional ability assessment
Description
The 6-minute walk test was used to assess functional abilities.
Time Frame
after 12 weeks
Title
Physical activity level assessment
Description
The Adolescents' Physical Activity Questionnaire (PAQ-A) in Arabic edition was used to measure the physical activity level assessment.
Time Frame
at first week
Title
Physical activity level assessment
Description
The Adolescents' Physical Activity Questionnaire (PAQ-A) in Arabic edition was used to measure the physical activity level assessment.
Time Frame
after 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshimaa Azab, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Khalid Hospital
City
Al-Kharj
State/Province
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
Citations:
PubMed Identifier
11851757
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.
Results Reference
background
PubMed Identifier
10647529
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.
Results Reference
background
PubMed Identifier
26613579
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.
Results Reference
result

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Hemophilic Knee Arthropathy Virtual Reality

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