HemophiliahemophiliaNCT05802368
Hemophilic Knee Arthropathy Virtual Reality
A study testing virtual reality group and exercise group in people with Hemophilia and Knee Arthropathy, run by Maged Basha at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 10 to 14 years, men only
- Conditions the study is for
- Hemophilia, Knee Arthropathy
- What is being tested?
- virtual reality group and exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Nov 2021to 23 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hemophilia, Knee Arthropathy
- Being tested
- virtual reality group, exercise group
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality groupOther
Also called Kinect based virtual reality combined with physical exercises
a 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy.
exercise groupOther
Also called physical exercises alone
Traditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | a 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy. Receives: 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 Receives: Other: exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after 12 weeks
Secondary outcomes (4)
Functional ability assessment
The 6-minute walk test was used to assess functional abilities.
Measured: at first week
Functional ability assessment
The 6-minute walk test was used to assess functional abilities.
Measured: after 12 weeks
Physical activity level assessment
The Adolescents' Physical Activity Questionnaire (PAQ-A) in Arabic edition was used to measure the physical activity level assessment.
Measured: at first week
Physical activity level assessment
The Adolescents' Physical Activity Questionnaire (PAQ-A) in Arabic edition was used to measure the physical activity level assessment.
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start10 Nov 2021
- Primary completion16 Oct 2022
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maged Basha
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Responsible party
- Sponsor-investigator, Maged Basha, Qassim University
- Investigators
- Alshimaa Azab, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802368
- Sponsor's protocol ID
- RHPT/0021/0023
- Acronym
- hemophilia
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
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.
PubMed 11851757Falk 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.
PubMed 10647529Regaieg 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.
PubMed 26613579
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05802368
- Acronym / sponsor ID
- hemophilia / RHPT/0021/0023
- Conditions
- Hemophilia, Knee Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Maged BashaUniversity, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 16 Oct 2022 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: virtual reality group, Other: exercise groupa 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy. |
| control group | Experimental | Other: exercise groupTraditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality groupAlso: Kinect based virtual reality combined with physical exercisesa 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy. | Other | study group |
| exercise groupAlso: physical exercises aloneTraditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least | Other | control group, study group |
Primary outcome
Gait Analysis
Time frame: at first week
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
Time frame: after 12 weeks
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.
4 secondary outcomes
Functional ability assessment
Time frame: at first week
Functional ability assessment
Time frame: after 12 weeks
Physical activity level assessment
Time frame: at first week
Physical activity level assessment
Time frame: after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 11851757Hilberg 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.
- Background: PubMed 10647529Falk 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 publication: PubMed 26613579Regaieg 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.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alshimaa Azab, PhD principal investigator
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality group and exercise group in people with Hemophilia and Knee Arthropathy, run by Maged Basha at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Analysis (time frame: at first week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802368, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.