Knee InjuriesNCT05080894
Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction
A study testing Virtual reality in people with Knee Injuries, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 1 site in Spain.
Trial summary
The purpose of this study is to ascertain whether 4 weeks of daily virtual-reality-based rehabilitation at home improves disability in the early stages of recovery from anterior cruciate ligament reconstruction surgery compared with standard care. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 15 Dec 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-40 (either sex)
- Post-operative anterior cruciate ligament reconstruction (autograft), either bone-patellar tendon-bone graft or semitendinosus (hamstring) graft
Who cannot join
- Patients with significant cognitive deficit (MEC<24).
- Patients with epilepsy or severe vision problems
- Pregnant patients
- Previous surgery on the reconstructed knee, excluding arthroscopy
- Previous anterior cruciate ligament reconstruction on either knee
- Sustained concurrent injury to the contralateral knee
- Concomitant collateral ligament and/or meniscal repair
- Presence of symptomatic tibiofemoral osteoarthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Domestic Rehabilitation Using Virtual Reality for Patients With Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
The purpose of this study is to ascertain whether 4 weeks of daily virtual-reality-based rehabilitation at home improves disability in the early stages of recovery from anterior cruciate ligament reconstruction surgery compared with standard care.
Read the detailed description
After being informed about the study and potential risks and benefits, patients giving written informed consent will be randomized to one of two groups in a 1:1 ratio. The treatment group will perform daily a 20-minute rehabilitation session in virtual reality, in which they will observe their virtual body performing a series of exercises they would otherwise be unable to perform in real life. Both groups will also undergo the standard rehabilitation protocol. The investigators will assess for differences between groups in self-reported disability, knee range of motion, and quadriceps strength at baseline, 4 weeks, 12 weeks and 9 months.
- Conditions
- Knee Injuries
- Being tested
- Virtual reality
- Keywords
- virtual reality, embodiment, rehabilitation, anterior cruciate ligament reconstruction
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Embodiment of a healthy virtual body in virtual reality and action observation/motor imagery of the subject's virtual body performing high-level lower limb exercises.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Daily 20-minute sessions of virtual reality based rehabilitation for the first 4 weeks post-operatively + standard rehabilitation protocol Receives: Device: Virtual reality |
| Standard intervention | No intervention | Standard rehabilitation protocol only |
What is being measured
The primary outcome is the main question the study is designed to answer.
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: Baseline (day 1 post-surgery)
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: 4 weeks
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: 12 weeks
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: 9 months
Secondary outcomes (13)
Isometric quadriceps strength
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Measured: Baseline
Isometric quadriceps strength
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Measured: 4 weeks
Isometric quadriceps strength
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Measured: 12 weeks
Isometric quadriceps strength
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Measured: 9 months
Knee extension active range of motion
Measured with a digital goniometer (smartphone app)
Measured: Baseline
Knee extension active range of motion
Measured with a digital goniometer (smartphone app)
Measured: 4 weeks
Knee extension active range of motion
Measured with a digital goniometer (smartphone app)
Measured: 12 weeks
Knee extension active range of motion
Measured with a digital goniometer (smartphone app)
Measured: 9 months
Time taken to return to sporting activity
Taken retrospectively at 9 months, number of days from surgery to full return to sport
Measured: 9 months
Kinesiophobia
Fear of movement as measured with the Tampa scale of kinesiophobia
Measured: Baseline
Kinesiophobia
Fear of movement as measured with the Tampa scale of kinesiophobia
Measured: 4 weeks
Kinesiophobia
Fear of movement as measured with the Tampa scale of kinesiophobia
Measured: 12 weeks
Kinesiophobia
Fear of movement as measured with the Tampa scale of kinesiophobia
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 Oct 2021
- Primary completion15 Nov 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee InjuriesStudies 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
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Responsible party
- Principal investigator, Prof. Maria V. Sanchez-Vives, Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Investigators
- Maria V. Sanchez-Vives, Principal investigator, Institut d'Investigacions Biomèdiques August Pi i Sunyer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080894
- Sponsor's protocol ID
- HCB-2019-0670
- Status last verified
- Apr 2024
- First submitted
- 20 Sep 2021
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donegan T, Amestoy-Alonso B, Spanlang B, Sastre S, Combalia A, Sanchez-Vives MV. Decreased kinesiophobia with virtual embodiment for post-surgical knee rehabilitation: a randomized controlled trial. J Orthop Surg Res. 2026 Apr 26;21(1):356. doi: 10.1186/s13018-026-06865-6.
PubMed 42036710
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Domestic Rehabilitation Using Virtual Reality for Patients With Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05080894
- Acronym / sponsor ID
- HCB-2019-0670
- Conditions
- Knee Injuries
- Keywords
- virtual reality, embodiment, rehabilitation, anterior cruciate ligament reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Institut d'Investigacions Biomèdiques August Pi i SunyerUniversity, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 18 Oct 2021 (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.
The purpose of this study is to ascertain whether 4 weeks of daily virtual-reality-based rehabilitation at home improves disability in the early stages of recovery from anterior cruciate ligament reconstruction surgery compared with standard care.
Detailed description
After being informed about the study and potential risks and benefits, patients giving written informed consent will be randomized to one of two groups in a 1:1 ratio. The treatment group will perform daily a 20-minute rehabilitation session in virtual reality, in which they will observe their virtual body performing a series of exercises they would otherwise be unable to perform in real life. Both groups will also undergo the standard rehabilitation protocol. The investigators will assess for differences between groups in self-reported disability, knee range of motion, and quadriceps strength at baseline, 4 weeks, 12 weeks and 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual realityDaily 20-minute sessions of virtual reality based rehabilitation for the first 4 weeks post-operatively + standard rehabilitation protocol |
| Standard intervention | No intervention | –Standard rehabilitation protocol only |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18-40 (either sex)
- Post-operative anterior cruciate ligament reconstruction (autograft), either bone-patellar tendon-bone graft or semitendinosus (hamstring) graft
Key exclusion criteria (8 listed)
- Patients with significant cognitive deficit (MEC<24).
- Patients with epilepsy or severe vision problems
- Pregnant patients
- Previous surgery on the reconstructed knee, excluding arthroscopy
- Previous anterior cruciate ligament reconstruction on either knee
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 realityEmbodiment of a healthy virtual body in virtual reality and action observation/motor imagery of the subject's virtual body performing high-level lower limb exercises. | Device | Virtual reality |
Primary outcome
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Time frame: Baseline (day 1 post-surgery)
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Time frame: 4 weeks
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Time frame: 12 weeks
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Time frame: 9 months
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
13 secondary outcomes
Isometric quadriceps strength
Time frame: Baseline
Isometric quadriceps strength
Time frame: 4 weeks
Isometric quadriceps strength
Time frame: 12 weeks
Isometric quadriceps strength
Time frame: 9 months
Knee extension active range of motion
Time frame: Baseline
Knee extension active range of motion
Time frame: 4 weeks
Knee extension active range of motion
Time frame: 12 weeks
Knee extension active range of motion
Time frame: 9 months
Time taken to return to sporting activity
Time frame: 9 months
Kinesiophobia
Time frame: Baseline
Kinesiophobia
Time frame: 4 weeks
Kinesiophobia
Time frame: 12 weeks
Kinesiophobia
Time frame: 9 months
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 18 Apr 2024.
- Derived from this study: PubMed 42036710Donegan T, Amestoy-Alonso B, Spanlang B, Sastre S, Combalia A, Sanchez-Vives MV. Decreased kinesiophobia with virtual embodiment for post-surgical knee rehabilitation: a randomized controlled trial. J Orthop Surg Res. 2026 Apr 26;21(1):356. doi: 10.1186/s13018-026-06865-6.
- 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.
Maria V. Sanchez-Vives principal investigator
Institut d'Investigacions Biomèdiques August Pi i Sunyer
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 in people with Knee Injuries, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 1 site in Spain.
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 8 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 18 Apr 2024. 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 Spain. 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?
The International Knee Documentation Committee (IKDC) Subjective Knee Form (time frame: Baseline (day 1 post-surgery)). The study lists 4 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 NCT05080894, which also lists 1 linked publication.
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 18 Apr 2024.