Meniscus InjuryNCT06870825
Assessment of Quadriceps Femoris Muscle Function in Patients After Arthroscopic Knee Surgery in Outpatient Rehabilitation
A study testing High-intensity Magnetic Field Muscle Stimulation and Transcutaneous Neuromuscular Electrical Stimulation in people with Meniscus Injury and Meniscus Tear, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
The goal of this clinical trial is to learn if a high intensity magnetic field is an effective way to treat quadriceps muscle atrophy after knee arthroscopic surgery in adult patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Meniscus Injury, Meniscus Tear, Arthroscopic Knee Surgeries
- What is being tested?
- High-intensity Magnetic Field Muscle Stimulation and Transcutaneous Neuromuscular Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jan 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older (working age).
- 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
Who cannot join
- Contraindications to electrostimulation or high-intensity magnetic therapy:
- Epilepsy
- Implanted electrical devices
- Acute rhythm disorders
- Oncological diseases (near the stimulation site, active treatment)
- Sensory disorders
Show all 11Show fewer
- Skin lesions (near the stimulation site)
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if a high intensity magnetic field is an effective way to treat quadriceps muscle atrophy after knee arthroscopic surgery in adult patients. The main questions it aims to answer are:
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.
Read more
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.
Read the detailed description
The purpose of this study is to evaluate the effectiveness of quadriceps muscle stimulation methods: transcutaneous neuromuscular electrostimulation (standard methodology) and high-intensity magnetic field (innovative methodology) stimulation in the rehabilitation of patients after arthroscopic knee surgery, and the impact of the applied methods on the quality of life.
Objectives:
- 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.
- 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.
- 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.
- 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.
- Being tested
- High-intensity Magnetic Field Muscle Stimulation, Transcutaneous Neuromuscular Electrical Stimulation
- Keywords
- arthroscopic knee surgery, quadriceps femoris atrophy, neuromuscular electrical stimulation, high intensity magnetic field stimulation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity Magnetic Field Muscle StimulationDevice
- The procedure is performed for 20 min., 1k/d, 5k/week, a total of 14 times (rehabilitation duration 14 days).
- Parameters: applied parameters according to the manufacturer's specified program for muscle stimulation: "muscle strengthening" program
- 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.
- device: BLT Super Inductive System
- Along with muscle stimulation techniques, all subjects will undergo a standardized outpatient rehabilitation plan.
Transcutaneous Neuromuscular Electrical StimulationDevice
- the procedure is performed for 20 min., 1k/d, 5k/week, a total of 14 times (rehab. duration 14 days).
- Parameters: applied parameters according to the manufacturer's specified program for muscle stimulation (EMS, P3)
- Stimulation site: quadriceps femoris muscle, applied above the motor point.
- device: ITO ES-5200
- Along with muscle stimulation techniques, all subjects will undergo a standardized outpatient rehabilitation plan.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity magnetic field muscle stimulation group | Experimental | Group will receive High-intensity magnetic field muscle stimulation group to treat quadriceps muscle atrophy Receives: Device: High-intensity Magnetic Field Muscle Stimulation |
| Transcutaneous neuromuscular electrical stimulation group | Active comparator | Group will receive a Transcutaneous neuromuscular electrical stimulation to treat quadriceps muscle atrophy Receives: Device: Transcutaneous Neuromuscular Electrical Stimulation |
| Control group | No intervention | A Control group, that will receive a standard outpatient rehabilitation plan, without additional quadriceps muscle stimulation methodology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thigh circumference measurement with a centimeter tape (cm)
Measuring thigh circumference using a centimeter tape (cm) is a simple yet effective way to track changes in muscle mass, body composition, or to monitor progress. In order to obtain accurate data, the distance between the anterior angle of the iliac wing and the upper edge of the patella is measured with a centimeter tape. Mark the point: ⅓ from the edge of the patella. At the marked point, the thigh circumference is estimated with a centimeter tape, the measurement is repeated 3 times, and the average of the measurements is derived.
Measured: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Ultrasound assessment of quadriceps muscle cross-sectional area
Ultrasound (Mindray DC-80a device) Subject position: During the study, the subject lies on his back, with the knee joints in 15° passive flexion (a cushion is used under the knee joints). During the study, the participants were instructed to relax the thigh muscles. Measurements are performed after the subject has been in a horizontal position for 5 min., to determine the distribution of body fluids [Berg et al., 1993]. Assessment methodology: in order to obtain accurate data, the distance between the greater trochanter of the femur and the upper edge of the patella is measured with a centimeter tape. A point is marked in the distal quarter (75% of the total distance). At the marked point, the ultrasound transducer is placed perpendicular to the longitudinal axis of the thigh on the medial surface, the edge of the quadriceps muscle VM is visualized, and from the starting point, a continuous single image is scanned with the transducer traveling transversely across the thigh along the m
Measured: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Muscle echogenicity assessed by ultrasound
is performed using an ultrasound device (Mindray, DC-80a), in order to obtain accurate data, the distance between the greater trochanter of the femur and the upper edge of the patella is measured with a centimeter tape. A point is marked in the distal quarter (75% of the total distance). At the marked points, the ultrasound transducer is placed perpendicular to the longitudinal axis of the thigh. At the mentioned points, the heads of the quadriceps muscle are visualized, with clear contours, and the image is captured. The image is processed by the ImageJ program, and the visual quantitative scale (VAS echogenicity) is evaluated from 0 to 100.
Measured: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Muscle strength/power (kg), assessed with a hand-held dynamometer
Quadriceps muscle strength will be assessed manually using a manual muscle testing device - Lafayette. Measurements are performed with the subject sitting; the back is supported, the pelvis and knees are bent at an angle of 90°. Then the subjects voluntarily perform 3 consecutive maximal voluntary extensions through the knee joint. (contraction time 3 sec., rest time 7 sec.), the highest value during the assessment was considered the maximal force.
Measured: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Knee joint pain intensity
Pain at rest and during movement will be assessed using the visual analogue scale (VAS)-a line marked with dashes and marked with 11 numbers, from 0 to 10. The subject will be asked to mark a number that indicates the intensity of the pain experienced. Pain is assessed on a scale of 0 to 10, where 0 is no pain, 1, 2, 3 is mild pain, 4, 5, 6 is severe pain, 7, 8, 9 is very severe pain, and 10 is unbearable pain.
Measured: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Secondary outcomes (4)
Range of motion through the knee joint
Active range of motion through the joints is measured with a plastic goniometer (SEAHAN® Grid, 360° per 1° 20 cm) using the neutral zero method. The minimum significant change in range of motion is 5°. The measurements will be repeated three times. After adding all the results obtained during one measurement, the arithmetic mean is calculated.
Measured: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
6-minute walk test
The test was used to assess the level of physical fitness. Subjects were asked to walk at their usual maximum pace along a 30-meter long, level, straight hospital corridor without encouragement. The test measured the distance the patient walked in 6 minutes.
Measured: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Quality of life questionnaire
The European Quality of Life and Health Status Questionnaire (EQ-5D-3L) is a standardized quality of life and health status assessment scale developed by the international EuroQoL group. This questionnaire consists of two parts: i. a descriptive part of 5 questions, in which the subject rates his/her health status in 5 dimensions: mobility, self-care, usual activities, pain or discomfort, anxiety or depression, choosing from three options (no problems, some problems or moderate pain, major problems); ii. a visual analogue scale, in which the subject is asked to rate his/her health status on a scale from 0 to 100, where 100 is the highest rating and 0 is the lowest.
Measured: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Tolerating of interventions
Patients are asked to answer the following questions posed by the researcher:
- "Did you experience any discomfort/pain during the procedure?"
- "What was the intensity of the discomfort/pain during the stimulation and for the first 2-3 hours after the stimulation" (subjects were asked to rate the pain on the VAS scale)
- "Do you have any other comments that are important to you about the discomfort/sensations experienced during the procedure? If so, describe them"
Measured: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jan 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus InjuryStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gintare Repeckaite, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870825
- Sponsor's protocol ID
- P2-BE-2-60/2024
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For now, we do not have enough human and financial resources to share IPD, but if our circumstances change, we are open to reconsider this decision.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quadriceps Femoris Muscle Function in Patients After Arthroscopic Knee Surgery in Outpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT06870825
- Acronym / sponsor ID
- P2-BE-2-60/2024
- Keywords
- arthroscopic knee surgery, quadriceps femoris atrophy, neuromuscular electrical stimulation, high intensity magnetic field stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 11 Mar 2025 (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 goal of this clinical trial is to learn if a high intensity magnetic field is an effective way to treat quadriceps muscle atrophy after knee arthroscopic surgery in adult patients. The main questions it aims to answer are:
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.
Detailed description
The purpose of this study is to evaluate the effectiveness of quadriceps muscle stimulation methods: transcutaneous neuromuscular electrostimulation (standard methodology) and high-intensity magnetic field (innovative methodology) stimulation in the rehabilitation of patients after arthroscopic knee surgery, and the impact of the applied methods on the quality of life.
Objectives:
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-intensity magnetic field muscle stimulation group | Experimental | Device: High-intensity Magnetic Field Muscle StimulationGroup will receive High-intensity magnetic field muscle stimulation group to treat quadriceps muscle atrophy |
| Transcutaneous neuromuscular electrical stimulation group | Active comparator | Device: Transcutaneous Neuromuscular Electrical StimulationGroup will receive a Transcutaneous neuromuscular electrical stimulation to treat quadriceps muscle atrophy |
| Control group | No intervention | –A Control group, that will receive a standard outpatient rehabilitation plan, without additional quadriceps muscle stimulation methodology. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and older (working age).
- 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
Key exclusion criteria (11 listed)
- Contraindications to electrostimulation or high-intensity magnetic therapy:
- 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
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 |
|---|---|---|
| High-intensity Magnetic Field Muscle Stimulation1. 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. | Device | High-intensity magnetic field muscle stimulation group |
| Transcutaneous Neuromuscular Electrical Stimulation1. 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. | Device | Transcutaneous neuromuscular electrical stimulation group |
Primary outcome
Thigh circumference measurement with a centimeter tape (cm)
Time frame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Measuring thigh circumference using a centimeter tape (cm) is a simple yet effective way to track changes in muscle mass, body composition, or to monitor progress. In order to obtain accurate data, the distance between the anterior angle of the iliac wing and the upper edge of the patella is measured with a centimeter tape. Mark the point: ⅓ from the edge of the patella. At the marked point, the thigh circumference is estimated with a centimeter tape, the measurement is repeated 3 times, and the average of the measurements is derived.
Ultrasound assessment of quadriceps muscle cross-sectional area
Time frame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Ultrasound (Mindray DC-80a device) Subject position: During the study, the subject lies on his back, with the knee joints in 15° passive flexion (a cushion is used under the knee joints). During the study, the participants were instructed to relax the thigh muscles. Measurements are performed after the subject has been in a horizontal position for 5 min., to determine the distribution of body fluids [Berg et al., 1993]. Assessment methodology: in order to obtain accurate data, the distance between the greater trochanter of the femur and the upper edge of the patella is measured with a centimeter tape. A point is marked in the distal quarter (75% of the total distance). At the marked point, the ultrasound transducer is placed perpendicular to the longitudinal axis of the thigh on the medial surface, the edge of the quadriceps muscle VM is visualized, and from the starting point, a continuous single image is scanned with the transducer traveling transversely across the thigh along the m
Muscle echogenicity assessed by ultrasound
Time frame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
is performed using an ultrasound device (Mindray, DC-80a), in order to obtain accurate data, the distance between the greater trochanter of the femur and the upper edge of the patella is measured with a centimeter tape. A point is marked in the distal quarter (75% of the total distance). At the marked points, the ultrasound transducer is placed perpendicular to the longitudinal axis of the thigh. At the mentioned points, the heads of the quadriceps muscle are visualized, with clear contours, and the image is captured. The image is processed by the ImageJ program, and the visual quantitative scale (VAS echogenicity) is evaluated from 0 to 100.
Muscle strength/power (kg), assessed with a hand-held dynamometer
Time frame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Quadriceps muscle strength will be assessed manually using a manual muscle testing device - Lafayette. Measurements are performed with the subject sitting; the back is supported, the pelvis and knees are bent at an angle of 90°. Then the subjects voluntarily perform 3 consecutive maximal voluntary extensions through the knee joint. (contraction time 3 sec., rest time 7 sec.), the highest value during the assessment was considered the maximal force.
Knee joint pain intensity
Time frame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Pain at rest and during movement will be assessed using the visual analogue scale (VAS)-a line marked with dashes and marked with 11 numbers, from 0 to 10. The subject will be asked to mark a number that indicates the intensity of the pain experienced. Pain is assessed on a scale of 0 to 10, where 0 is no pain, 1, 2, 3 is mild pain, 4, 5, 6 is severe pain, 7, 8, 9 is very severe pain, and 10 is unbearable pain.
4 secondary outcomes
Range of motion through the knee joint
Time frame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
6-minute walk test
Time frame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Quality of life questionnaire
Time frame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Tolerating of interventions
Time frame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No. For now, we do not have enough human and financial resources to share IPD, but if our circumstances change, we are open to reconsider this decision.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity Magnetic Field Muscle Stimulation and Transcutaneous Neuromuscular Electrical Stimulation in people with Meniscus Injury and Meniscus Tear, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2025. 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 Lithuania. 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?
This study is still under way. Results are not available in the source record yet.
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?
Thigh circumference measurement with a centimeter tape (cm) (time frame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2025.