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

JRCT ID: jRCTs052240172

Registered date:29/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: meniscal injury
• Date of first enrollment: 29/10/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): rehabilitation

Outcome(s)

Primary Outcome

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 Outcome

(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 of disease incidences and their contents
Rate of serious desease incidences, number of serious desease incidences and their contents
2. Malfunction of devices
Presence of malfunction, number of malfunctions and their contents

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include 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 are possible to do the self-training by oneself at home using the application supporting rehabilitation and the shoes with built-in sensors
6. Gender is not considered
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. If patients are aged under 18, a written consent of the legal representative in addition to the patient must be obtained.

Exclude criteria

Patients who are judged difficult to do the self-training using the application supporting rehabilitation and the shoes with built-in sensors are excluded as written below
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 the principal investigator or a subinvestigator to have difficulty in performing independent training using the rehabilitation support application and sensor-embedded shoes for patients

Related Information

• Primary Sponsor: Tsujii Akira
• Secondary Sponsor: Nakata Ken
• Source(s) of Monetary Support: ORPHE Inc.