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| Name | Class |
|---|---|
| Fundación Mutua Madrileña | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality | Experimental | Daily 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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). | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Isometric quadriceps strength | Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons) | Baseline |
| Isometric quadriceps strength | Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria V. Sanchez-Vives | Institut d'Investigacions Biomèdiques August Pi i Sunyer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IDIBAPS | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42036710 | Derived | 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. |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| 4 weeks |
| Isometric quadriceps strength | Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons) | 12 weeks |
| Isometric quadriceps strength | Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons) | 9 months |
| Knee extension active range of motion | Measured with a digital goniometer (smartphone app) | Baseline |
| Knee extension active range of motion | Measured with a digital goniometer (smartphone app) | 4 weeks |
| Knee extension active range of motion | Measured with a digital goniometer (smartphone app) | 12 weeks |
| Knee extension active range of motion | Measured with a digital goniometer (smartphone app) | 9 months |
| Time taken to return to sporting activity | Taken retrospectively at 9 months, number of days from surgery to full return to sport | 9 months |
| Kinesiophobia | Fear of movement as measured with the Tampa scale of kinesiophobia | Baseline |
| Kinesiophobia | Fear of movement as measured with the Tampa scale of kinesiophobia | 4 weeks |
| Kinesiophobia | Fear of movement as measured with the Tampa scale of kinesiophobia | 12 weeks |
| Kinesiophobia | Fear of movement as measured with the Tampa scale of kinesiophobia | 9 months |