Sport InjuryNCT04592900
Comparing VR and Balance Exercises In Rehabilitation of Adolescent Athletes
A study testing balance exercising in people with Sport Injury, run by South Valley University at 1 site in Egypt.
Trial summary
Ankle sprains are common injuries in active young people. Most of these injuries recovery quickly on their own, do not require imaging, and do better with early motion and rehabilitation. High ankle sprains and fractures are much less common but more serious. They may require imaging and more treatment. Read more about this study
- Who is it for?
- Ages 13 to 16 years, men only
- Conditions the study is for
- Sport Injury
- What is being tested?
- balance exercising
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 Oct 2020
- 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 13 to 16 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children will have sustained lateral ankle sprain (grade II).
- Their age was ranging from 13-16 years
- All children with stable medical and psychological status.
- They will able to follow the verbal commands or instructions during testing.
Who cannot join
- Children with ankle or foot deformity
- Unstable medical and psychological status.
- Children not able to follow the verbal commands or instructions during testing
- Children with any disorder affecting balance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Versus Biodex Balance Training In Adolescent Athletes With Chronic Ankle Instability.
Ankle sprains are common injuries in active young people. Most of these injuries recovery quickly on their own, do not require imaging, and do better with early motion and rehabilitation. High ankle sprains and fractures are much less common but more serious. They may require imaging and more treatment.
Read the detailed description
Phases of rehabilitation for ankle sprain Phase I treatment involves resting and protecting the ankle to permit healing, to prevent further injury, and to control pain and swelling.
Phase II treatment begins once pain and swelling have subsided to the point where the athlete can comfortably bear weight and walk from place to place.
Virtual reality (VR) is a simulated experience that can be similar to or completely different from the real world. Applications of virtual reality can include entertainment (i.e. video games) and educational purposes (i.e. medical or military training). Other, distinct types of VR style technology include augmented reality and mixed reality.
Biodex Balance Training is one of the main tool that used to assess dynamic balance and dynamic limits of stability also it can used as training tool to improve the participant balance training
- Conditions
- Sport Injury
- Being tested
- balance exercising
- Keywords
- BalanceTraining,, Virtual Reality,, Ankle Instability.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance exercisingOther
selected physical therapy program strengthening the muscles of upper and lower limbs, balancing exercise, gait training in open environment,stretching for elbow flexors and forearms pronators,lower limb hip flexors and knee extensor and ankle dorsiflexors
| Study group | Role | What they receive |
|---|---|---|
| the control group | Experimental | the control group Group 1 the control group received selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand supinator, wrist extensors, knee extensors and ankle dorsiflexors, balancing exercises, coordination exercises and balance training exercises and gait training in open environment. Receives: Other: balance exercising |
| the virtual reality group | Experimental | Group 2 the study group received the same physical therapy program 30 min. plus virtual reality for 30 min Receives: Other: balance exercising |
| the Biodex Balance Training group | Experimental | Group 3 the study group received the same physical therapy program 30 min. plus virtual reality for 30 min Receives: Other: balance exercising |
What is being measured
The primary outcome is the main question the study is designed to answer.
dynamic balance test
antro-posterior stability index
Measured: antro-posterior stability index at day 0
dynamic balance test
antro-posterior stability index
Measured: antro-posterior stability index at day 90
dynamic balance test
medio-lateral stability index
Measured: medio-lateral stability index at day 0
dynamic balance test
medio-lateral stability index
Measured: medio-lateral stability index at day 90
dynamic balance test
overall stability index
Measured: overall stability index at day 0
dynamic balance test
overall stability index
Measured: overall stability index at day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Aug 2018
- Primary completion1 Aug 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sport InjuryStudies 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
- Model description
- G 1 (control) received traditional physical therapy program for 60 min. G 2(study) received traditional physical therapy program for 30 min. and virtual reality for 30 min. G 3 (study) received traditional physical therapy program for 30 min. and Biodex Balance Training all groups treated for four successive months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehad Ahmed Youness Abo-zaid, South Valley University
- Investigators
- Nehad A Abo-zaid, Principal investigator, South Valley University, Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592900
- Sponsor's protocol ID
- P.T.REC/012/002877
- Status last verified
- Mar 2021
- First submitted
- 6 Oct 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pommering TL, Kluchurosky L, Hall SL. Ankle and foot injuries in pediatric and adult athletes. Prim Care. 2005 Mar;32(1):133-61. doi: 10.1016/j.pop.2004.11.003.
PubMed 15831316Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ Jr. The epidemiology of ankle sprains in the United States. J Bone Joint Surg Am. 2010 Oct 6;92(13):2279-84. doi: 10.2106/JBJS.I.01537.
PubMed 20926721Hootman JM, Dick R, Agel J. Epidemiology of collegiate injuries for 15 sports: summary and recommendations for injury prevention initiatives. J Athl Train. 2007 Apr-Jun;42(2):311-9.
PubMed 17710181Williams MA, Soiza RL, Jenkinson AM, Stewart A. EXercising with Computers in Later Life (EXCELL) - pilot and feasibility study of the acceptability of the Nintendo(R) WiiFit in community-dwelling fallers. BMC Res Notes. 2010 Sep 13;3:238. doi: 10.1186/1756-0500-3-238.
PubMed 20831836Arifin N, Abu Osman NA, Wan Abas WA. Intrarater test-retest reliability of static and dynamic stability indexes measurement using the Biodex Stability System during unilateral stance. J Appl Biomech. 2014 Apr;30(2):300-4. doi: 10.1123/jab.2013-0130. Epub 2013 Jul 20.
PubMed 23878204
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Versus Biodex Balance Training In Adolescent Athletes With Chronic Ankle Instability.
- ClinicalTrials.gov ID
- NCT04592900
- Acronym / sponsor ID
- P.T.REC/012/002877
- Conditions
- Sport Injury
- Keywords
- BalanceTraining,, Virtual Reality,, Ankle Instability.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 19 Oct 2020 (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.
Ankle sprains are common injuries in active young people. Most of these injuries recovery quickly on their own, do not require imaging, and do better with early motion and rehabilitation. High ankle sprains and fractures are much less common but more serious. They may require imaging and more treatment.
Detailed description
Phases of rehabilitation for ankle sprain Phase I treatment involves resting and protecting the ankle to permit healing, to prevent further injury, and to control pain and swelling.
Phase II treatment begins once pain and swelling have subsided to the point where the athlete can comfortably bear weight and walk from place to place.
Virtual reality (VR) is a simulated experience that can be similar to or completely different from the real world. Applications of virtual reality can include entertainment (i.e. video games) and educational purposes (i.e. medical or military training). Other, distinct types of VR style technology include augmented reality and mixed reality.
Biodex Balance Training is one of the main tool that used to assess dynamic balance and dynamic limits of stability also it can used as training tool to improve the participant balance training
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- G 1 (control) received traditional physical therapy program for 60 min. G 2(study) received traditional physical therapy program for 30 min. and virtual reality for 30 min. G 3 (study) received traditional physical therapy program for 30 min. and Biodex Balance Training all groups treated for four successive months.
| Arm | Type | Receives |
|---|---|---|
| the control group | Experimental | Other: balance exercisingthe control group Group 1 the control group received selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand supinator, wrist extensors, knee extensors and ankle dorsiflexors, balancing exercises, coordination exercises and balance training exercises and gait training in open environment. |
| the virtual reality group | Experimental | Other: balance exercisingGroup 2 the study group received the same physical therapy program 30 min. plus virtual reality for 30 min |
| the Biodex Balance Training group | Experimental | Other: balance exercisingGroup 3 the study group received the same physical therapy program 30 min. plus virtual reality for 30 min |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children will have sustained lateral ankle sprain (grade II).
- Their age was ranging from 13-16 years
- All children with stable medical and psychological status.
- They will able to follow the verbal commands or instructions during testing.
Key exclusion criteria (4 listed)
- Children with ankle or foot deformity
- Unstable medical and psychological status.
- Children not able to follow the verbal commands or instructions during testing
- Children with any disorder affecting balance.
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 |
|---|---|---|
| balance exercisingselected physical therapy program strengthening the muscles of upper and lower limbs, balancing exercise, gait training in open environment,stretching for elbow flexors and forearms pronators,lower limb hip flexors and knee extensor and ankle dorsiflexors | Other | the Biodex Balance Training group, the control group, the virtual reality group |
Primary outcome
dynamic balance test
Time frame: antro-posterior stability index at day 0
antro-posterior stability index
dynamic balance test
Time frame: antro-posterior stability index at day 90
antro-posterior stability index
dynamic balance test
Time frame: medio-lateral stability index at day 0
medio-lateral stability index
dynamic balance test
Time frame: medio-lateral stability index at day 90
medio-lateral stability index
dynamic balance test
Time frame: overall stability index at day 0
overall stability index
dynamic balance test
Time frame: overall stability index at day 90
overall stability index
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 9 Mar 2021.
- Background: PubMed 15831316Pommering TL, Kluchurosky L, Hall SL. Ankle and foot injuries in pediatric and adult athletes. Prim Care. 2005 Mar;32(1):133-61. doi: 10.1016/j.pop.2004.11.003.
- Background: PubMed 20926721Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ Jr. The epidemiology of ankle sprains in the United States. J Bone Joint Surg Am. 2010 Oct 6;92(13):2279-84. doi: 10.2106/JBJS.I.01537.
- Background: PubMed 17710181Hootman JM, Dick R, Agel J. Epidemiology of collegiate injuries for 15 sports: summary and recommendations for injury prevention initiatives. J Athl Train. 2007 Apr-Jun;42(2):311-9.
- Background: PubMed 20831836Williams MA, Soiza RL, Jenkinson AM, Stewart A. EXercising with Computers in Later Life (EXCELL) - pilot and feasibility study of the acceptability of the Nintendo(R) WiiFit in community-dwelling fallers. BMC Res Notes. 2010 Sep 13;3:238. doi: 10.1186/1756-0500-3-238.
- Background: PubMed 23878204Arifin N, Abu Osman NA, Wan Abas WA. Intrarater test-retest reliability of static and dynamic stability indexes measurement using the Biodex Stability System during unilateral stance. J Appl Biomech. 2014 Apr;30(2):300-4. doi: 10.1123/jab.2013-0130. Epub 2013 Jul 20.
- Individual participant dataSharing planned: No
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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.
Nehad A Abo-zaid principal investigator
South Valley University, Faculty of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balance exercising in people with Sport Injury, run by South Valley University at 1 site in Egypt.
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 4 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 9 Mar 2021. 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 Egypt. 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?
dynamic balance test (time frame: antro-posterior stability index at day 0). The study lists 6 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 NCT04592900, which also lists 5 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 9 Mar 2021.