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A pilot study to evaluate the program supporting rehabilitation in patients with meniscal injury

A pilot study of evaluate the Software as a Medical Device supporting rehabilitation in patients with meniscal injury

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052240172
Enrollment
20
Registered
2024-10-29
Start date
2024-10-29
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

meniscal injury meniscal injury

Interventions

rehabilitation

Sponsors

Tsujii Akira
Lead Sponsor
Nakata Ken
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 16 or older 2. Patients with meniscal injury including concomitant anterior cruciate ligament injury or knee osteoarthritis 3. Patients who underwent meniscus repair for the meniscal injury within one month or plan to undergo the surgery 4. Patients who are possible to undertake the standard rehabilitation as an outpatient after meniscal repair 5. Patients who use smartphones (running iOS) and are possible to download and use mobile apps for research 6. Patients who are able to do self-training outside of the hospital using rehabilitation support apps and sensor-equipped shoes by themselves. 7. Patients who are possible to give a written consent after understanding the content of the informed consent form including the conduct of the rehabilitation in the study.

Exclusion criteria

Exclusion criteria: 1. Patients who are suffering from serious mental diseases or dementia 2. Patients who are suffering from neurological diseases affecting motor functions 3. Patients who are suffering from diseases other than meniscal injury restricting physical activity and are difficult to do the self-training 4. Patients who have already initiated rehabilitation as outpatients after leaving the hospital 5. Patients who plan to undertake rehabilitation as outpatients three times or more weekly after meniscal repair 6. Patients who are judged at the enrollment unlikely to complete the observation period for 6 months 7. In addition to 1-6, patients who are judged by t he principal investigator or a subinvestigator to ha ve difficulty in performing independent training us ing the rehabilitation support application and sens or-embedded shoes for patients

Design outcomes

Primary

MeasureTime frame
Recovery rate (%) of quadriceps muscle at 3 months after the surgery using the multipurpose exercise equipment measuring muscle function (Biodex) Isometric flexion (%) Isometric extension (%)

Secondary

MeasureTime frame
(Efficacy) 1. Rate of the patients who achieve the recovery rate of 70% or more at 3 months after the surgery as to the primary evaluation item 2. Recovery rate (%) of quadriceps muscle at 4 and 5 months after the surgery using the multipurpose exercise equipment measuring muscle function (Biodex) Isometric flexion (%) Isometric extension (%) 3. Recovery rate (%) of quadriceps muscle at 6 months after the surgery using the multipurpose exercise equipment measuring muscle function (Biodex) Isokinetic flexion (%) Isokinetic extension (%) The following evaluation items at 3 and 6 months after the surgery 4. Patient-based outcomes (patient questionnaire) KOOS [Knee injury and Osteoarthritis Outcome Score] IKDC [International Knee Documentation Committee] 5. Clinical symptoms IKDC Knee examination form (swelling, ROM, knee stability, hop) 6. Range of motion of knee joint Flexion angle (degree) Extension angle (degree) Achievement rate (%) of standard criteria (within 3 degrees of recovery) 7. Rnage of motion of knee joint (heel height difference) Extension (cm) 8. Gait analysis When treadmil walking Measurment with built-in sensors in shoes (stride length, stride time, standing time, swing time, cadence, walking speed, ground angle, takeoff angle, pronation), optical motion capture system (joint angle) When hallway walking Measurment with built-in sensors in shoes (stride length, stride time, standing time, swing time, cadence, walking speed, ground angle, takeoff angle, pronation), optical motion capture system (joint angle), joint moment, ground reaction force 9. Status of activities Possibility of jogging Possibility of jampping Return to sports 10. Training conditions Rehabilitation status as outpatients (Safety) 1. Adverse events Rate of adverse events, number of adverse events and their contents Rate of disease incidences, number

Contacts

Public ContactMutsumi Sato

The University of Osaka Hospital

mutsumi.sato@mspa.med.osaka-u.ac.jp+81-6-6210-8439

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026