Motor ActivityNCT03900351
Influence of Virtual Reality Games on Knee Proprioception After Anterior Cruciate Ligament Reconstruction (ACLR)
A study testing Wii fit protocol of virtual reality games and Regular exercise rehabilitation protocol in people with Motor Activity and Proprioceptive Disorders, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
Influence of virtual reality games(Wii Fit) on knee proprioception after anterior cruciate ligament reconstruction (ACLR) will be measured in 30 postoperative patients. The age of participants will be ranged from 20 to 30 years old. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Motor Activity, Proprioceptive Disorders, Balance; Distorted
- What is being tested?
- Wii fit protocol of virtual reality games and Regular exercise rehabilitation protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 7 Apr 2019to 13 Jun 2019
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who will be in the early postoperative phase (week 2 after surgery)
- patients with BMI less than 25, and more than 20.
Who cannot join
- Patients with injury or operation accompanied by the ACLR as meniscectomy.
- Patients with any deformities affecting knee joint alignment as genu valgus, genu varus, or genu recurvatum.
Trial locations and contacts
1 site in 1 country.
About this study
Influence of virtual reality games(Wii Fit) on knee proprioception after anterior cruciate ligament reconstruction (ACLR) will be measured in 30 postoperative patients. The age of participants will be ranged from 20 to 30 years old. Subjects will be randomly assigned to Group A is the study group and Group B is the control group.
Read the detailed description
Group A will receive the Wii fit protocol of virtual reality games, in addition to the regular exercise rehabilitation protocol, for 3 non-consecutive days per week, for 8 weeks , 40 minutes for each session. Group B will receive the regular exercise rehabilitation protocol only for 3 non-consecutive days per week for 8 weeks, 40 minutes for each session.
A Universal Weight and Height Scale: will be used to measure the patient's BMI.
Biodex Isokinetic Dynamometer: will be used to assess the knee proprioception of the affected operated leg at three target angles (30,45,and 60 degrees).
- Conditions
- Motor Activity, Proprioceptive Disorders, Balance; Distorted
- Being tested
- Wii fit protocol of virtual reality games, Regular exercise rehabilitation protocol
- Medical subject headings
- Motor Activity, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii fit protocol of virtual reality gamesProcedure or surgery
the Wii fit session by standing on the Wii fit board with bare feet, hands on hips and both eyes open. Pretest on Wii fit was done to make the subject familiar with the board and tasks of weight shift .
Regular exercise rehabilitation protocolProcedure or surgery
It will be according to the criterion of Adams et al. (2012).
| Study group | Role | What they receive |
|---|---|---|
| Group A: Study group | Active comparator | They will receive the Wii fit protocol of virtual reality games for 40 minutes, 3 times per week, for 8 weeks, in addition to the regular exercise rehabilitation protocol according to the criterion of Adams et al. (2012). Receives: Procedure: Wii fit protocol of virtual reality games; Procedure: Regular exercise rehabilitation protocol |
| Group B: Control group | Experimental | They will receive the regular exercise rehabilitation protocol only for 40 minutes, for 3 days per week, for 8 weeks. Receives: Procedure: Regular exercise rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee proprioception at 30 degrees
Biodex Isokinetic Dynamometer will be used to measure knee proprioception.
Measured: 3 minutes
knee proprioception at 45 degrees
Biodex Isokinetic Dynamometer will be used to measure knee proprioception.
Measured: 3 minutes
knee proprioception at 60 degrees
Biodex Isokinetic Dynamometer will be used to measure knee proprioception
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start7 Apr 2019
- Primary completion6 Jun 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies 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
- There are two group of subjects: 1. Group A (study group). 2. Group B:(Control group).
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohammed Moustafa, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900351
- Sponsor's protocol ID
- 2387594650
- Status last verified
- Jun 2019
- First submitted
- 1 Apr 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Virtual Reality Games on Knee Proprioception After Anterior Cruciate Ligament Reconstruction (ACLR)
- ClinicalTrials.gov ID
- NCT03900351
- Acronym / sponsor ID
- 2387594650
- Conditions
- Motor Activity, Proprioceptive Disorders, Balance; Distorted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of JazanOther government
- Study start
- 7 Apr 2019 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 3 Apr 2019 (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.
Influence of virtual reality games(Wii Fit) on knee proprioception after anterior cruciate ligament reconstruction (ACLR) will be measured in 30 postoperative patients. The age of participants will be ranged from 20 to 30 years old. Subjects will be randomly assigned to Group A is the study group and Group B is the control group.
Detailed description
Group A will receive the Wii fit protocol of virtual reality games, in addition to the regular exercise rehabilitation protocol, for 3 non-consecutive days per week, for 8 weeks , 40 minutes for each session. Group B will receive the regular exercise rehabilitation protocol only for 3 non-consecutive days per week for 8 weeks, 40 minutes for each session.
A Universal Weight and Height Scale: will be used to measure the patient's BMI.
Biodex Isokinetic Dynamometer: will be used to assess the knee proprioception of the affected operated leg at three target angles (30,45,and 60 degrees).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two group of subjects: 1. Group A (study group). 2. Group B:(Control group).
| Arm | Type | Receives |
|---|---|---|
| Group A: Study group | Active comparator | Procedure: Wii fit protocol of virtual reality games, Procedure: Regular exercise rehabilitation protocolThey will receive the Wii fit protocol of virtual reality games for 40 minutes, 3 times per week, for 8 weeks, in addition to the regular exercise rehabilitation protocol according to the criterion of Adams et al. (2012). |
| Group B: Control group | Experimental | Procedure: Regular exercise rehabilitation protocolThey will receive the regular exercise rehabilitation protocol only for 40 minutes, for 3 days per week, for 8 weeks. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients who will be in the early postoperative phase (week 2 after surgery)
- patients with BMI less than 25, and more than 20.
Key exclusion criteria (2 listed)
- Patients with injury or operation accompanied by the ACLR as meniscectomy.
- Patients with any deformities affecting knee joint alignment as genu valgus, genu varus, or genu recurvatum.
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 |
|---|---|---|
| Wii fit protocol of virtual reality gamesthe Wii fit session by standing on the Wii fit board with bare feet, hands on hips and both eyes open. Pretest on Wii fit was done to make the subject familiar with the board and tasks of weight shift . | Procedure or surgery | Group A: Study group |
| Regular exercise rehabilitation protocolIt will be according to the criterion of Adams et al. (2012). | Procedure or surgery | Group A: Study group, Group B: Control group |
Primary outcome
knee proprioception at 30 degrees
Time frame: 3 minutes
Biodex Isokinetic Dynamometer will be used to measure knee proprioception.
knee proprioception at 45 degrees
Time frame: 3 minutes
Biodex Isokinetic Dynamometer will be used to measure knee proprioception.
knee proprioception at 60 degrees
Time frame: 3 minutes
Biodex Isokinetic Dynamometer will be used to measure knee proprioception
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 14 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wii fit protocol of virtual reality games and Regular exercise rehabilitation protocol in people with Motor Activity and Proprioceptive Disorders, run by University of Jazan 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 2 inclusion and 2 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 14 Jun 2019. 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?
knee proprioception at 30 degrees (time frame: 3 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2019.