Assessment of Quadriceps Femoris Muscle Function in Patients After Arthroscopic Knee Surgery in Outpatient Rehabilitation
NCT ID: NCT06870825
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2025-01-01
2027-08-01
Brief Summary
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Is high intensity magnetic field muscle stimulation is an effective way to treat quadriceps muscle atrophy Is high intensity magnetic field muscle stimulation is more effective and more tolerable option for quadriceps muscle stimulation than transcutaneous muscle electrical stimulation Researchers will compare high intensity magnetic field muscle stimulation to transcutaneous muscle electrical stimulation and control group, to see if high intensity magnetic field muscle stimulation works to treat quadriceps muscle atrophy.
Participants will:
receive high intensity magnetic field or transcutaneous muscle electrical stimulation 1 time/day for 14 days, Visit the rehabilitation department for testing before/after and 1 month after rehabilitation.
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Detailed Description
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Objectives:
1. To evaluate and check the quadriceps muscle volume, strength, knee joint motion amplitude, pain intensity before and after outpatient rehabilitation and to identify factors that may influence their occurrence.
2. To evaluate and compare the effectiveness of transcutaneous neuromuscular electrical stimulation and high-intensity magnetic field stimulation on changes in quadriceps muscle volume and strength in patients undergoing outpatient rehabilitation after knee joint arthroscopic surgeries.
3. To evaluate the impact of quadriceps muscle size and strength reduction on movement function and quality of life during outpatient rehabilitation, to evaluate changes in condition after outpatient rehabilitation and the previous 1 month, to compare the results obtained.
4. To establish and compare the tolerance of different muscle stimulation methods used and possible adverse reactions after arthroscopic knee joint surgeries.
Subject of the study:
Patients undergoing outpatient rehabilitation, according to the profile of musculoskeletal injuries, 14 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High-intensity magnetic field muscle stimulation group
Group will receive High-intensity magnetic field muscle stimulation group to treat quadriceps muscle atrophy
High-intensity Magnetic Field Muscle Stimulation
1. The procedure is performed for 20 min., 1k/d, 5k/week, a total of 14 times (rehabilitation duration 14 days).
2. Parameters: applied parameters according to the manufacturer's specified program for muscle stimulation: "muscle strengthening" program
3. Stimulation site: quadriceps femoris muscle, applied above the motor point approximately 60% of the distance from the upper medial border of the patella to the anterior upper wing of the iliac bone.
4. device: BLT Super Inductive System
* Along with muscle stimulation techniques, all subjects will undergo a standardized outpatient rehabilitation plan.
Transcutaneous neuromuscular electrical stimulation group
Group will receive a Transcutaneous neuromuscular electrical stimulation to treat quadriceps muscle atrophy
Transcutaneous Neuromuscular Electrical Stimulation
1. the procedure is performed for 20 min., 1k/d, 5k/week, a total of 14 times (rehab. duration 14 days).
2. Parameters: applied parameters according to the manufacturer's specified program for muscle stimulation (EMS, P3)
3. Stimulation site: quadriceps femoris muscle, applied above the motor point.
4. device: ITO ES-5200
* Along with muscle stimulation techniques, all subjects will undergo a standardized outpatient rehabilitation plan.
Control group
A Control group, that will receive a standard outpatient rehabilitation plan, without additional quadriceps muscle stimulation methodology.
No interventions assigned to this group
Interventions
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High-intensity Magnetic Field Muscle Stimulation
1. The procedure is performed for 20 min., 1k/d, 5k/week, a total of 14 times (rehabilitation duration 14 days).
2. Parameters: applied parameters according to the manufacturer's specified program for muscle stimulation: "muscle strengthening" program
3. Stimulation site: quadriceps femoris muscle, applied above the motor point approximately 60% of the distance from the upper medial border of the patella to the anterior upper wing of the iliac bone.
4. device: BLT Super Inductive System
* Along with muscle stimulation techniques, all subjects will undergo a standardized outpatient rehabilitation plan.
Transcutaneous Neuromuscular Electrical Stimulation
1. the procedure is performed for 20 min., 1k/d, 5k/week, a total of 14 times (rehab. duration 14 days).
2. Parameters: applied parameters according to the manufacturer's specified program for muscle stimulation (EMS, P3)
3. Stimulation site: quadriceps femoris muscle, applied above the motor point.
4. device: ITO ES-5200
* Along with muscle stimulation techniques, all subjects will undergo a standardized outpatient rehabilitation plan.
Eligibility Criteria
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Inclusion Criteria
* Arthroscopic knee joint surgery performed
* The dr. orthopedic traumatologist allowed the operated limb to be activated - and rehabilitation to begin
* The period between the operation and the start of rehabilitation is not shorter than 4 weeks and not longer than 2 months.
* Impaired self-service or movement function: Barthel index 80 points or more (according to the order of the Ministry of Health of the Republic of Lithuania) Subjects agreeing to participate in the study
Exclusion Criteria
1. Epilepsy
2. Implanted electrical devices
3. Acute rhythm disorders
4. Oncological diseases (near the stimulation site, active treatment)
5. Sensory disorders
6. Skin lesions (near the stimulation site)
7. Pregnancy.
* Cannot perform the functional tests presented in the study.
* Subjects who cannot be treated with a standardized outpatient rehabilitation plan due to other contraindications (e.g. IC, DVT)
* Subjects who refuse to participate in the study
18 Years
65 Years
ALL
No
Sponsors
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Lithuanian University of Health Sciences
OTHER
Responsible Party
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Gintare Repeckaite
assistant teacher, phd student.
Locations
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Lithuanian University of Health Sciences
Kaunas, , Lithuania
Countries
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Other Identifiers
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P2-BE-2-60/2024
Identifier Type: -
Identifier Source: org_study_id
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