Familial Mediterranean Fever (FMF )NCT07013045
Comparing Structured Neuromuscular Exercise and Exergaming Program in Adolescents With Familial Mediterranean Fever
A study testing Structured Neuromuscular Exercise Group and Neuromuscular Exergaming Program Group in people with Familial Mediterranean Fever (FMF ), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Familial Mediterranean Fever (FMF) is an autosomal recessive, autoinflammatory disease characterized by recurrent fever attacks and inflammation of the serous membranes. FMF is defined by short, self-limiting inflammatory attacks that typically resolve within 1-3 days, and classic symptoms during an attack include… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Familial Mediterranean Fever (FMF )
- What is being tested?
- Structured Neuromuscular Exercise Group and Neuromuscular Exergaming Program Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Sep 2026
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged between 12 and 18 years
- Diagnosed with FMF at least 6 months ago at the Istanbul Faculty of Medicine, Pediatric Rheumatology Clinic
- Receiving routine medical treatment for FMF
- Being in an attack-free period
- Being willing to participate in the study
Who cannot join
- Having any chronic systemic disease other than FMF
- Having balance problems of vestibular or neurological origin
- Positive Fukuda (Unterberger) Test
- Having visual or hearing impairments
- Presence of scoliosis, leg length discrepancy, or recent lower extremity surgery
- Development of amyloidosis
Show all 10Show fewer
- Presence of acute pain due to any cause
- Withdrawal Criteria:
- Lack of cooperation with the exercise program
- Missing three consecutive exercise sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Effects of Structured Neuromuscular Exercise Training and Neuromuscular Exergaming Program in Adolescents Diagnosed With Familial Mediterranean Fever
Familial Mediterranean Fever (FMF) is an autosomal recessive, autoinflammatory disease characterized by recurrent fever attacks and inflammation of the serous membranes. FMF is defined by short, self-limiting inflammatory attacks that typically resolve within 1-3 days, and classic symptoms during an attack include fever, abdominal pain, chest pain, joint pain, and swelling.
Adolescents with chronic illnesses face numerous challenges in participating in physical activity, and often the disease itself leads to deconditioning and a decline in functional ability. Previous studies have reported that adolescents with FMF have lower cardiorespiratory fitness, exercise capacity, and muscle strength compared to their healthy peers. Even during attack-free periods, children experience high levels of fatigue, lower motivation and activity levels, and problems with concentration.
Read more
In the literature, there is evidence that physical activity and exercise programs are safe and feasible in rheumatic diseases such as Juvenile Systemic Lupus Erythematosus, Juvenile Idiopathic Arthritis, Juvenile Fibromyalgia, and Juvenile Dermatomyositis. These programs have been shown to improve patients' functional capacities, physical fitness, and reduce fatigue. However, only one study has been found regarding the effectiveness of physical activity and exercise programs in patients with FMF. This study compared the effectiveness of physical activity counseling and a 12-week online aerobic dance program conducted twice a week. It was found that both interventions led to positive improvements in functional capacity and physical fitness in children and adolescents with FMF, and aerobic dance was found to be feasible in this population. Accordingly, it is evident that further studies comparing the effects of different types of exercise in adolescents with FMF are needed in the literature.
Neuromuscular exercise is defined as a type of training that aims to improve the ability to generate controlled movement through coordinated muscle activation by enhancing various parameters such as muscle strength, flexibility, balance, and agility. Neuromuscular training programs conducted over 6-12 weeks have been shown to positively affect performance-related parameters in adolescent athletes from different sports disciplines, improve motor skills and motor control, enhance balance, proprioception, and core stabilization, reduce injury incidence, and improve both health- and skill-related physical fitness parameters.
Exergaming, derived from the combination of exercise training and video gaming, has gained significant popularity over the past few decades. In the literature, it has been found to improve muscular fitness and physical activity in obese children and adolescents, reduce the perception of fatigue and dyspnea in patients with Cystic Fibrosis, and be a safe option in various conditions with impaired neuromotor control, such as Down Syndrome, Developmental Coordination Disorder, and Cerebral Palsy. However, no study has been found investigating the effectiveness of exergaming in adolescents with FMF.
The aim of our study is to compare the effects of structured neuromuscular exercise training and a neuromuscular exergaming program in adolescents diagnosed with FMF.
- Conditions
- Familial Mediterranean Fever (FMF )
- Being tested
- Structured Neuromuscular Exercise Group, Neuromuscular Exergaming Program Group
- Keywords
- Familial Mediterranean Fever, Neuromuscular exercise, exergame
- Medical subject headings
- Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Neuromuscular Exercise GroupOther
In the Structured Neuromuscular Exercise group, the exercise program will be administered to patients diagnosed with FMF twice a week for 12 weeks under the supervision of a physiotherapist. The exercises will be performed using a balance board and will include sitting, standing, lunge, modified push-up, and plank positions.
Neuromuscular Exergaming Program GroupOther
In the Neuromuscular Exergaming group, patients diagnosed with FMF will perform the same exercises as those in the structured neuromuscular exercise program, delivered in an exergaming format using the Smart Exercise Board (SEG-Board). The program will be conducted under the supervision of a physiotherapist, twice weekly for 12 weeks, and will include exercises performed in sitting, standing, lunge, modified push-up, and plank positions.
| Study group | Role | What they receive |
|---|---|---|
| Structured Neuromuscular Exercise Training Group | Experimental | In the Structured Neuromuscular Exercise group, the exercise program will be implemented under the supervision of a physiotherapist for 12 weeks, twice a week, in patients diagnosed with FMF. Receives: Other: Structured Neuromuscular Exercise Group |
| Neuromuscular Exergaming Program Group | Experimental | In the Neuromuscular Exergaming program, the same exercises included in the Structured Neuromuscular Exercise group will be applied to patients diagnosed with FMF through an exergaming format, under the supervision of a physiotherapist, for 12 weeks, twice a week. Receives: Other: Neuromuscular Exergaming Program Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-Stair Climb Test (10-SCT)
The 10-SCT is commonly used to assess functional capacity in adolescents with chronic rheumatic diseases. During the test, participants will be asked to climb 10 steps (14x28x120 cm) as quickly as possible. The time taken to ascend the stairs will be recorded in seconds using a stopwatch.
Measured: From enrollment to the end of treatment at 12 weeks
6-Minute Walk Test (6MWT)
The 6MWT is a simple, easy-to-administer, and well-tolerated test that reflects the submaximal level of functional capacity. It measures the distance a patient can walk quickly on a hard, flat surface within six minutes. Participants will be instructed on how to perform the test, and the distance walked in six minutes will be recorded in meters. The 6MWT will be used to assess the functional capacity of the participants.
Measured: From enrollment to the end of treatment at 12 weeks
30 Second Sit-to-Stand Test
The 30SST is one of the tests used to assess lower extremity functional strength and performance in adolescents. During the test, participants will sit in the center of an armless chair with a seat height of 45 cm, feet flat on the floor, and arms crossed over their chest. Upon the evaluator's command, they will be instructed to stand up fully and sit back down using both lower limbs, completing as many sit-to-stand-to-sit cycles as possible within 30 seconds. Participants will also be instructed to perform at their maximum effort. The 30SST will be used to evaluate the functional performance of the lower extremities.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (11)
FitnessGram Physical Activity Test Battery- Curl-up Test
The curl-up test will be used to assess the abdominal muscle strength and endurance of the participants. The test will begin with the patient lying supine on an exercise mat, knees flexed at approximately 140°, feet flat on the floor, and legs slightly apart. Arms will be positioned parallel to the body and the floor, with palms placed flat on the ground and fingers extended. The goal of the test is to perform as many curl-ups as possible at a controlled pace. The rhythm of the test will be set to 20 curl-ups per minute, or one curl-up every 3 seconds. A maximum of 75 curl-ups will be counted. The test will end when the participant completes 75 curl-ups, fails to perform two consecutive repetitions correctly, or is unable to continue.
Measured: From enrollment to the end of treatment at 12 weeks
FitnessGram Physical Activity Test Battery- Push-up Test
The push-up test will be used to assess upper extremity muscle strength and endurance. The test will begin with the patient in a prone position on an exercise mat, with hands placed at or slightly wider than shoulder-width apart, fingers extended, palms flat on the floor, and legs slightly apart. During the test, participants will lower their torso toward the floor by bending their elbows to approximately 90°, then push themselves back up to the starting position. The pace will be set at 20 push-ups per minute, or one push-up every 3 seconds. The test will be terminated if the participant makes two errors.
Measured: From enrollment to the end of treatment at 12 weeks
FitnessGram Physical Activity Test Battery- Trunk Lift Test
The trunk lift test will be used to assess trunk extensor muscle strength and flexibility. The test will begin with the patient lying in a prone position on an exercise mat, with hands placed under the thighs. During the test, participants will slowly and in a controlled manner lift their upper body up to a maximum height of 12 inches (30.48 cm). At the end of the test, the distance between the participant's chin and the floor will be measured with a tape measure and recorded in centimeters.
Measured: From enrollment to the end of treatment at 12 weeks
FitnessGram Physical Activity Test Battery- Back-Saver Sit and Reach Test
This test allows for the assessment of each leg separately, enabling the identification of any asymmetry in hamstring flexibility and helping to prevent knee hyperextension. The back-saver sit and reach test will be used to assess hamstring flexibility in patients. A test box is required for the procedure, measuring 35 cm in length, 45 cm in width, and 32 cm in height, with a top plate measuring 50 cm in length and 45 cm in width placed on top. During the test, participants will remove their shoes and sit in front of the test box. One leg will remain extended while the other is flexed. Participants will place one hand on top of the other and reach forward four times, holding the fourth reach for one second. The procedure will be repeated for the opposite leg. The distance reached will be recorded in centimeters.
Measured: From enrollment to the end of treatment at 12 weeks
Progressive Aerobic Cardiovascular Endurance Run (PACER)
The PACER test is a modified version of the 20-meter shuttle run test and consists of multiple stages. It will be used to assess the aerobic capacity of the participants. During the test, patients will be asked to run back and forth between two cones placed 20 meters apart, following a pre-recorded audio cue set to music standardized by the Cooper Institute. The test begins at a slow pace and progressively increases in speed each minute. The test will be terminated when the participant can no longer maintain the required pace for their current level. If a participant fails to reach the cone at the sound of the beep for the first time, they will be instructed to continue running in the opposite direction and try to maintain the rhythm. At the end of the test, the total number of laps completed, including the lap that could not be completed, will be recorded.
Measured: From enrollment to the end of treatment at 12 weeks
Kinvent K-Plate Measurement System
The KPlate, included in the Kinvent Measurement Set, will be used to evaluate the patients' static and dynamic balance.
Measured: From enrollment to the end of treatment at 12 weeks
Digitsole Pro® System
The Digitsole Pro® system is capable of measuring walking patterns and gait variables under real-life conditions. The smart insoles of Digitsole Pro® can be placed inside any shoe, allowing for the measurement of spatial, temporal, and kinematic gait parameters. Gait profile of the patients will be assessed using Digitsole Pro®.
Measured: From enrollment to the end of treatment at 12 weeks
Fatigue Assessment Scale
The Fatigue Assessment Scale is a 10-item questionnaire that includes five questions on physical fatigue and five on mental fatigue. It will be used to evaluate the fatigue levels of the patients.
Measured: From enrollment to the end of treatment at 12 weeks
Kinvent K-Pull Measurement System
The K-Pull device, included in the Kinvent Measurement Set, will be used to assess the quadriceps and hamstring muscle strength of the patients.
Measured: From enrollment to the end of treatment at 12 weeks
Physical Activity
The physical activity levels of the patients will be monitored using a smartwatch. The participants' step counts will be recorded via a smartwatch for a period of 3 months.
Measured: From enrollment to the end of treatment at 12 weeks
Exercise Satisfaction
Patients' satisfaction levels will be assessed with Numerical Rating Scale. A score of 0 indicates no satisfaction from exercise, while a score of 10 indicates very high satisfaciton from exercise.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean Fever (FMF )Studies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asya Albayrak, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013045
- Sponsor's protocol ID
- fmfthesis
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Structured Neuromuscular Exercise Training and Neuromuscular Exergaming Program in Adolescents Diagnosed With Familial Mediterranean Fever
- ClinicalTrials.gov ID
- NCT07013045
- Acronym / sponsor ID
- fmfthesis
- Conditions
- Familial Mediterranean Fever (FMF )
- Keywords
- Familial Mediterranean Fever, Neuromuscular exercise, exergame
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 10 Jun 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.
Familial Mediterranean Fever (FMF) is an autosomal recessive, autoinflammatory disease characterized by recurrent fever attacks and inflammation of the serous membranes. FMF is defined by short, self-limiting inflammatory attacks that typically resolve within 1-3 days, and classic symptoms during an attack include fever, abdominal pain, chest pain, joint pain, and swelling.
Adolescents with chronic illnesses face numerous challenges in participating in physical activity, and often the disease itself leads to deconditioning and a decline in functional ability. Previous studies have reported that adolescents with FMF have lower cardiorespiratory fitness, exercise capacity, and muscle strength compared to their healthy peers. Even during attack-free periods, children experience high levels of fatigue, lower motivation and activity levels, and problems with concentration.
In the literature, there is evidence that physical activity and exercise programs are safe and feasible in rheumatic diseases such as Juvenile Systemic Lupus Erythematosus, Juvenile Idiopathic Arthritis, Juvenile Fibromyalgia, and Juvenile Dermatomyositis. These programs have been shown to improve patients' functional capacities, physical fitness, and reduce fatigue. However, only one study has been found regarding the effectiveness of physical activity and exercise programs in patients with FMF. This study compared the effectiveness of physical activity counseling and a 12-week online aerobic dance program conducted twice a week. It was found that both interventions led to positive improvements in functional capacity and physical fitness in children and adolescents with FMF, and aerobic dance was found to be feasible in this population. Accordingly, it is evident that further studies comparing the effects of different types of exercise in adolescents with FMF are needed in the literature.
Neuromuscular exercise is defined as a type of training that aims to improve the ability to generate controlled movement through coordinated muscle activation by enhancing various parameters such as muscle strength, flexibility, balance, and agility. Neuromuscular training programs conducted over 6-12 weeks have been shown to positively affect performance-related parameters in adolescent athletes from different sports disciplines, improve motor skills and motor control, enhance balance, proprioception, and core stabilization, reduce injury incidence, and improve both health- and skill-related physical fitness parameters.
Exergaming, derived from the combination of exercise training and video gaming, has gained significant popularity over the past few decades. In the literature, it has been found to improve muscular fitness and physical activity in obese children and adolescents, reduce the perception of fatigue and dyspnea in patients with Cystic Fibrosis, and be a safe option in various conditions with impaired neuromotor control, such as Down Syndrome, Developmental Coordination Disorder, and Cerebral Palsy. However, no study has been found investigating the effectiveness of exergaming in adolescents with FMF.
The aim of our study is to compare the effects of structured neuromuscular exercise training and a neuromuscular exergaming program in adolescents diagnosed with FMF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Neuromuscular Exercise Training Group | Experimental | Other: Structured Neuromuscular Exercise GroupIn the Structured Neuromuscular Exercise group, the exercise program will be implemented under the supervision of a physiotherapist for 12 weeks, twice a week, in patients diagnosed with FMF. |
| Neuromuscular Exergaming Program Group | Experimental | Other: Neuromuscular Exergaming Program GroupIn the Neuromuscular Exergaming program, the same exercises included in the Structured Neuromuscular Exercise group will be applied to patients diagnosed with FMF through an exergaming format, under the supervision of a physiotherapist, for 12 weeks, twice a week. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged between 12 and 18 years
- Diagnosed with FMF at least 6 months ago at the Istanbul Faculty of Medicine, Pediatric Rheumatology Clinic
- Receiving routine medical treatment for FMF
- Being in an attack-free period
- Being willing to participate in the study
Key exclusion criteria (10 listed)
- Having any chronic systemic disease other than FMF
- Having balance problems of vestibular or neurological origin
- Positive Fukuda (Unterberger) Test
- Having visual or hearing impairments
- Presence of scoliosis, leg length discrepancy, or recent lower extremity surgery
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 |
|---|---|---|
| Structured Neuromuscular Exercise GroupIn the Structured Neuromuscular Exercise group, the exercise program will be administered to patients diagnosed with FMF twice a week for 12 weeks under the supervision of a physiotherapist. The exercises will be performed using a balance board and will include sitting, standing, lunge, modified push-up, and plank positions. | Other | Structured Neuromuscular Exercise Training Group |
| Neuromuscular Exergaming Program GroupIn the Neuromuscular Exergaming group, patients diagnosed with FMF will perform the same exercises as those in the structured neuromuscular exercise program, delivered in an exergaming format using the Smart Exercise Board (SEG-Board). The program will be conducted under the supervision of a physiotherapist, twice weekly for 12 weeks, and will include exercises performed in sitting, standing, lunge, modified push-up, and plank positions. | Other | Neuromuscular Exergaming Program Group |
Primary outcome
10-Stair Climb Test (10-SCT)
Time frame: From enrollment to the end of treatment at 12 weeks
The 10-SCT is commonly used to assess functional capacity in adolescents with chronic rheumatic diseases. During the test, participants will be asked to climb 10 steps (14x28x120 cm) as quickly as possible. The time taken to ascend the stairs will be recorded in seconds using a stopwatch.
6-Minute Walk Test (6MWT)
Time frame: From enrollment to the end of treatment at 12 weeks
The 6MWT is a simple, easy-to-administer, and well-tolerated test that reflects the submaximal level of functional capacity. It measures the distance a patient can walk quickly on a hard, flat surface within six minutes. Participants will be instructed on how to perform the test, and the distance walked in six minutes will be recorded in meters. The 6MWT will be used to assess the functional capacity of the participants.
30 Second Sit-to-Stand Test
Time frame: From enrollment to the end of treatment at 12 weeks
The 30SST is one of the tests used to assess lower extremity functional strength and performance in adolescents. During the test, participants will sit in the center of an armless chair with a seat height of 45 cm, feet flat on the floor, and arms crossed over their chest. Upon the evaluator's command, they will be instructed to stand up fully and sit back down using both lower limbs, completing as many sit-to-stand-to-sit cycles as possible within 30 seconds. Participants will also be instructed to perform at their maximum effort. The 30SST will be used to evaluate the functional performance of the lower extremities.
11 secondary outcomes
FitnessGram Physical Activity Test Battery- Curl-up Test
Time frame: From enrollment to the end of treatment at 12 weeks
FitnessGram Physical Activity Test Battery- Push-up Test
Time frame: From enrollment to the end of treatment at 12 weeks
FitnessGram Physical Activity Test Battery- Trunk Lift Test
Time frame: From enrollment to the end of treatment at 12 weeks
FitnessGram Physical Activity Test Battery- Back-Saver Sit and Reach Test
Time frame: From enrollment to the end of treatment at 12 weeks
Progressive Aerobic Cardiovascular Endurance Run (PACER)
Time frame: From enrollment to the end of treatment at 12 weeks
Kinvent K-Plate Measurement System
Time frame: From enrollment to the end of treatment at 12 weeks
Digitsole Pro® System
Time frame: From enrollment to the end of treatment at 12 weeks
Fatigue Assessment Scale
Time frame: From enrollment to the end of treatment at 12 weeks
Kinvent K-Pull Measurement System
Time frame: From enrollment to the end of treatment at 12 weeks
Physical Activity
Time frame: From enrollment to the end of treatment at 12 weeks
Exercise Satisfaction
Time frame: From enrollment to the end of treatment at 12 weeks
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 17 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Familial Mediterranean Fever (FMF )
Not yet recruitingPhase 3
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
Familial Mediterranean Fever, FMF
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
Not yet recruitingObservational study
Genotype and Phenotype in Pediatric Familial Mediterranean Fever
Familial Mediterranean Fever
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Recruiting
Metabolic Syndrome Resposne to Dietary Limitations in Familial Mediterranean Fever in Adolescents
Familial Mediterranean Fever (FMF ), Metabolic Syndrome
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.
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 Structured Neuromuscular Exercise Group and Neuromuscular Exergaming Program Group in people with Familial Mediterranean Fever (FMF ), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 10 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: enrolling by invitation, as of the sponsor's last update on 17 Jun 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 Turkey (Türkiye). 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?
10-Stair Climb Test (10-SCT) (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 3 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 17 Jun 2025.