StrokeNCT07914413
Foot Drop Rehabilitation and Mobility in Chronic Stroke
A study testing Conventional Physical Therapy Program and FES-Assisted Gait Training in people with Stroke, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
Stroke is a leading cause of long-term disability, frequently resulting in motor impairments, balance deficits, and walking difficulties that limit functional independence and quality of life. Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional Physical Therapy Program and FES-Assisted Gait Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Nov 2026to Nov 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 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male adults aged 50-60 years.
- Confirmed chronic post-stroke hemiplegia lasting more than six months, documented in medical records or confirmed by the treating physician, with MRI findings supporting the diagnosis as specified in the study protocol.
- Lower-limb spasticity graded 1, 1+, or 2 on the Modified Ashworth Scale.
- Ability to understand and follow instructions.
- Absence of serious or recurrent medical complications, as determined by the treating physician.
- Absence of significant hip or knee flexion contractures, Achilles tendon tightness, or major lower-limb rotational malalignment.
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- Intact common fibular (peroneal) nerve function and adequate function of the proximal lower-limb muscles required for the intervention.
- Absence of other medical or neurological conditions that could substantially affect balance, apart from stroke-related impairments.
- No concurrent treatment specifically intended to improve the affected lower-limb function during the study period.
Who cannot join
- Skin conditions or known allergies to adhesive tapes or materials used during the intervention.
- Visual, auditory, or perceptual impairments that may interfere with understanding instructions or participating safely in the study.
- A history of lower-limb surgery, as specified in the study protocol.
- A history of seizures or epilepsy.
- Botulinum toxin injections into the lower-limb muscles within the preceding six months or planned during the study period, or initiation or modification of antispasticity medication within the three months before baseline assessment, as specified in the protocol.
- Radiographically confirmed hip pathology that may be aggravated by the intervention, a history of hip or knee surgery, or peripheral neuropathy that may affect treatment safety or outcomes.
- Back disorders, sciatica, or spinal stenosis that may interfere with gait training or functional mobility.
- An implanted pacemaker or other electronic device that may be incompatible with functional electrical stimulation (FES).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Ehab Mohamed Abd El Kafy
Mecca, Mecca Region, 21955
Ehab M Abd El Kafy, PhD, +966531698541, emkafy@uqu.edu.sa
About this study
Official title: Impact of Foot Drop Rehabilitation on Functional Mobility and Quality of Life in Patients With Chronic Stroke: A Randomized Controlled Trial
Stroke is a leading cause of long-term disability, frequently resulting in motor impairments, balance deficits, and walking difficulties that limit functional independence and quality of life. Conventional rehabilitation approaches, including gait training and assistive devices, may not fully address these limitations. Functional electrical stimulation (FES) offers a complementary approach by activating targeted muscles through electrical impulses, potentially improving ankle control, gait performance, and mobility in individuals with post-stroke foot drop. However, variations in clinical outcomes, treatment protocols, and accessibility highlight the need for further investigation. Therefore, this study aims to evaluate the effects of FES on functional mobility and quality of life in individuals with chronic stroke.
Read the detailed description
Stroke is a leading cause of long-term disability worldwide and represents a substantial health burden for survivors, their families, and healthcare systems. Although advances in acute stroke management have improved survival rates, many survivors experience persistent neurological impairments and activity limitations that can adversely affect their independence and quality of life. Motor dysfunction is among the most common consequences of stroke, particularly in individuals with hemiparesis, and frequently manifests as muscle weakness, impaired selective motor control, abnormal muscle tone, reduced postural stability, and gait disturbances. These impairments can compromise functional mobility, increase the risk of falls, restrict participation in activities of daily living, and limit social reintegration. Consequently, restoring safe and efficient mobility and improving health-related quality of life are major priorities in stroke rehabilitation.
Conventional approaches to improving mobility after stroke typically involve task-specific gait training, balance exercises, strengthening, and the use of assistive devices, such as canes, walkers, and ankle-foot orthoses (AFOs). Although these interventions can improve functional performance, their effectiveness may be limited by the severity of motor impairment, inadequate muscle activation, persistent abnormal movement patterns, and difficulties achieving sufficient repetition of functional movements. Functional electrical stimulation (FES) has emerged as an adjunctive rehabilitation approach that may address some of these limitations by delivering controlled electrical impulses to peripheral nerves to elicit contractions in the targeted skeletal muscles. In individuals with stroke, FES is commonly applied to facilitate muscle activation during functional activities, particularly to improve ankle dorsiflexion during the swing phase of gait in patients with foot drop. By supporting more appropriate muscle activation and movement timing, FES may contribute to improved foot clearance, gait performance, and functional mobility. Its application has also been investigated in other neurological conditions, including spinal cord injury and other disorders associated with impaired voluntary muscle control.
Despite the potential benefits of FES, its clinical implementation in stroke rehabilitation remains variable. This variation may reflect differences in patient characteristics, stimulation protocols, treatment duration, device design, and outcome measures, as well as inconsistencies in the reported magnitude and durability of treatment effects. In addition, equipment costs, technical complexity, the need for appropriate patient selection, and limited access to specialized rehabilitation services may restrict its routine use in clinical practice. Importantly, improvements in specific motor functions or gait parameters do not necessarily translate into greater independence in daily activities or better perceived quality of life. Therefore, evaluating both functional and patient-centered outcomes is essential to determine the broader clinical value of FES.
Accordingly, this study aims to investigate the effectiveness of functional electrical stimulation for foot-drop rehabilitation in improving functional mobility and health-related quality of life among individuals with chronic stroke. By examining changes in functional performance alongside quality-of-life outcomes, the study seeks to provide evidence regarding the potential contribution of FES to comprehensive stroke rehabilitation and its role in promoting greater independence and participation in everyday life.
- Conditions
- Stroke
- Being tested
- Conventional Physical Therapy Program, FES-Assisted Gait Training
- Keywords
- Functional Mobility, Balance, Gait, Quality of Life, Functional Electrical Stimulation, Conventional Exercise Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical Therapy ProgramOther
This intervention will include core stability training, stretching exercises, strengthening and facilitation exercises for the affected lower-limb muscles, postural reaction training and gait training. Materials and Equipment Used for Conventional Physical Therapy: These include therapeutic mats, Bobath treatment tables. exercise balls, wedges, rolls, parallel bars, a stepper, a balance board, and obstacles.
FES-Assisted Gait TrainingDevice
FES-Assisted Gait Training Using the WalkAide® Foot-Drop Stimulator: During gait training, the WalkAide® device delivers functional electrical stimulation (FES) to help lift the foot during the swing phase of walking. The device is secured around the calf, with electrodes positioned near the head of the fibula to stimulate the common peroneal nerve and activate the ankle dorsiflexor muscles. An integrated tilt sensor detects the onset of the swing phase and automatically triggers electrical stimulation, while the stimulation parameters are adjusted to produce adequate ankle dorsiflexion and improve foot clearance during walking.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants assigned to the control group will receive a conventional physical therapy program lasting 90 minutes per session. The session will consist of two 40-minute components, separated by a 10-minute rest period. The first component will include core stability training, stretching exercises, strengthening and facilitation exercises for the affected lower-limb muscles, and postural reaction training. The second component will focus on gait training. The conventional physical therapy program will be administered by therapists experienced in stroke rehabilitation. Treatment will be provided three times per week for eight consecutive weeks. Receives: Other: Conventional Physical Therapy Program |
| Experimental Group | Experimental | Participants assigned to the experimental group will receive the same conventional physical therapy program as the control group, with the addition of FES-assisted gait training using the WalkAide® foot-drop stimulator. Each session will last 90 minutes and will consist of two 40-minute components separated by a 10-minute rest period. The first component will include core stability training, stretching exercises, strengthening and facilitation exercises for the affected lower-limb muscles, and postural reaction training. During the second component, participants will perform gait training with the WalkAide® device to deliver electrical stimulation to facilitate ankle dorsiflexion during walking. The intervention will be administered by physical therapists experienced in stroke rehabilitation, three times per week for eight consecutive weeks. Receives: Other: Conventional Physical Therapy Program; Device: FES-Assisted Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the gait parameter (stride length).
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: stride length (m).
Measured: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in the gait parameter (stride time).
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: stride time (second).
Measured: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in the gait parameter (velocity).
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: velocity (meter / second).
Measured: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in the Overall Stability Index {percentage value (%)} for Limit of Stability Test (test that assess the change in balance ability)
The Biodex Balance System will be used to assess the change in the Overall Stability Index. This test involves measurement of overall directional control which represented as a percentage value (%). The higher scores will indicate better balance control.
Measured: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in functional independence in activities of daily living, and quality of life will be assessed using the Barthel Index.
Change in functional independence in activities of daily living and quality of life, will be assessed using the Barthel Index. Higher scores indicate greater independence.
Measured: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in the Overall Stability Index {Time of Control (seconds)} for Limit of Stability Test (test that assess the change in balance ability)
The Biodex Balance System will be used to assess the change in the Time of Control of the Limit of Stability Test. This test involves measurement of total time required to complete the test (seconds), improvement in this parameter requires minimizing the time recorded to complete the test.
Measured: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Secondary outcomes (2)
The change in the six-minute walk test score.
The six-minute walk test (6MWT) will assess the distance that the participant's ability to walk for a total of six minutes on a hard, uneven surface. It has been used to determine exercise tolerance changes following interventions for healthy older adults.
Measured: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in the score of fall risk test .
The Biodex Balance System will be used to assess changes in the Overall Stability Index (OSI) during the Fall Risk Test. The results for each participant will be recorded and compared with the age-specific normative data available in the device software for children.
Measured: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Abd El Kafy, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914413
- Sponsor's protocol ID
- HAPO-02-K-012-2026
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: \- The data available is Case-by-case basis at the discretion of Primary Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Foot Drop Rehabilitation on Functional Mobility and Quality of Life in Patients With Chronic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07914413
- Acronym / sponsor ID
- HAPO-02-K-012-2026
- Conditions
- Stroke
- Keywords
- Functional Mobility, Balance, Gait, Quality of Life, Functional Electrical Stimulation, Conventional Exercise Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
Stroke is a leading cause of long-term disability, frequently resulting in motor impairments, balance deficits, and walking difficulties that limit functional independence and quality of life. Conventional rehabilitation approaches, including gait training and assistive devices, may not fully address these limitations. Functional electrical stimulation (FES) offers a complementary approach by activating targeted muscles through electrical impulses, potentially improving ankle control, gait performance, and mobility in individuals with post-stroke foot drop. However, variations in clinical outcomes, treatment protocols, and accessibility highlight the need for further investigation. Therefore, this study aims to evaluate the effects of FES on functional mobility and quality of life in individuals with chronic stroke.
Detailed description
Stroke is a leading cause of long-term disability worldwide and represents a substantial health burden for survivors, their families, and healthcare systems. Although advances in acute stroke management have improved survival rates, many survivors experience persistent neurological impairments and activity limitations that can adversely affect their independence and quality of life. Motor dysfunction is among the most common consequences of stroke, particularly in individuals with hemiparesis, and frequently manifests as muscle weakness, impaired selective motor control, abnormal muscle tone, reduced postural stability, and gait disturbances. These impairments can compromise functional mobility, increase the risk of falls, restrict participation in activities of daily living, and limit social reintegration. Consequently, restoring safe and efficient mobility and improving health-related quality of life are major priorities in stroke rehabilitation.
Conventional approaches to improving mobility after stroke typically involve task-specific gait training, balance exercises, strengthening, and the use of assistive devices, such as canes, walkers, and ankle-foot orthoses (AFOs). Although these interventions can improve functional performance, their effectiveness may be limited by the severity of motor impairment, inadequate muscle activation, persistent abnormal movement patterns, and difficulties achieving sufficient repetition of functional movements. Functional electrical stimulation (FES) has emerged as an adjunctive rehabilitation approach that may address some of these limitations by delivering controlled electrical impulses to peripheral nerves to elicit contractions in the targeted skeletal muscles. In individuals with stroke, FES is commonly applied to facilitate muscle activation during functional activities, particularly to improve ankle dorsiflexion during the swing phase of gait in patients with foot drop. By supporting more appropriate muscle activation and movement timing, FES may contribute to improved foot clearance, gait performance, and functional mobility. Its application has also been investigated in other neurological conditions, including spinal cord injury and other disorders associated with impaired voluntary muscle control.
Despite the potential benefits of FES, its clinical implementation in stroke rehabilitation remains variable. This variation may reflect differences in patient characteristics, stimulation protocols, treatment duration, device design, and outcome measures, as well as inconsistencies in the reported magnitude and durability of treatment effects. In addition, equipment costs, technical complexity, the need for appropriate patient selection, and limited access to specialized rehabilitation services may restrict its routine use in clinical practice. Importantly, improvements in specific motor functions or gait parameters do not necessarily translate into greater independence in daily activities or better perceived quality of life. Therefore, evaluating both functional and patient-centered outcomes is essential to determine the broader clinical value of FES.
Accordingly, this study aims to investigate the effectiveness of functional electrical stimulation for foot-drop rehabilitation in improving functional mobility and health-related quality of life among individuals with chronic stroke. By examining changes in functional performance alongside quality-of-life outcomes, the study seeks to provide evidence regarding the potential contribution of FES to comprehensive stroke rehabilitation and its role in promoting greater independence and participation in everyday life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional Physical Therapy ProgramParticipants assigned to the control group will receive a conventional physical therapy program lasting 90 minutes per session. The session will consist of two 40-minute components, separated by a 10-minute rest period. The first component will include core stability training, stretching exercises, strengthening and facilitation exercises for the affected lower-limb muscles, and postural reaction training. The second component will focus on gait training. The conventional physical therapy program will be administered by therapists experienced in stroke rehabilitation. Treatment will be provided three times per week for eight consecutive weeks. |
| Experimental Group | Experimental | Other: Conventional Physical Therapy Program, Device: FES-Assisted Gait TrainingParticipants assigned to the experimental group will receive the same conventional physical therapy program as the control group, with the addition of FES-assisted gait training using the WalkAide® foot-drop stimulator. Each session will last 90 minutes and will consist of two 40-minute components separated by a 10-minute rest period. The first component will include core stability training, stretching exercises, strengthening and facilitation exercises for the affected lower-limb muscles, and postural reaction training. During the second component, participants will perform gait training with the WalkAide® device to deliver electrical stimulation to facilitate ankle dorsiflexion during walking. The intervention will be administered by physical therapists experienced in stroke rehabilitation, three times per week for eight consecutive weeks. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male adults aged 50-60 years.
- Confirmed chronic post-stroke hemiplegia lasting more than six months, documented in medical records or confirmed by the treating physician, with MRI findings supporting the diagnosis as specified in the study protocol.
- Lower-limb spasticity graded 1, 1+, or 2 on the Modified Ashworth Scale.
- Ability to understand and follow instructions.
- Absence of serious or recurrent medical complications, as determined by the treating physician.
Key exclusion criteria (8 listed)
- Skin conditions or known allergies to adhesive tapes or materials used during the intervention.
- Visual, auditory, or perceptual impairments that may interfere with understanding instructions or participating safely in the study.
- A history of lower-limb surgery, as specified in the study protocol.
- A history of seizures or epilepsy.
- Botulinum toxin injections into the lower-limb muscles within the preceding six months or planned during the study period, or initiation or modification of antispasticity medication within the three months before baseline assessment, as specified in the protocol.
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 |
|---|---|---|
| Conventional Physical Therapy ProgramThis intervention will include core stability training, stretching exercises, strengthening and facilitation exercises for the affected lower-limb muscles, postural reaction training and gait training. Materials and Equipment Used for Conventional Physical Therapy: These include therapeutic mats, Bobath treatment tables. exercise balls, wedges, rolls, parallel bars, a stepper, a balance board, and obstacles. | Other | Control Group, Experimental Group |
| FES-Assisted Gait TrainingFES-Assisted Gait Training Using the WalkAide® Foot-Drop Stimulator: During gait training, the WalkAide® device delivers functional electrical stimulation (FES) to help lift the foot during the swing phase of walking. The device is secured around the calf, with electrodes positioned near the head of the fibula to stimulate the common peroneal nerve and activate the ankle dorsiflexor muscles. An integrated tilt sensor detects the onset of the swing phase and automatically triggers electrical stimulation, while the stimulation parameters are adjusted to produce adequate ankle dorsiflexion and improve foot clearance during walking. | Device | Experimental Group |
Primary outcome
Change in the gait parameter (stride length).
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: stride length (m).
Change in the gait parameter (stride time).
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: stride time (second).
Change in the gait parameter (velocity).
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: velocity (meter / second).
Change in the Overall Stability Index {percentage value (%)} for Limit of Stability Test (test that assess the change in balance ability)
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
The Biodex Balance System will be used to assess the change in the Overall Stability Index. This test involves measurement of overall directional control which represented as a percentage value (%). The higher scores will indicate better balance control.
Change in functional independence in activities of daily living, and quality of life will be assessed using the Barthel Index.
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in functional independence in activities of daily living and quality of life, will be assessed using the Barthel Index. Higher scores indicate greater independence.
Change in the Overall Stability Index {Time of Control (seconds)} for Limit of Stability Test (test that assess the change in balance ability)
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
The Biodex Balance System will be used to assess the change in the Time of Control of the Limit of Stability Test. This test involves measurement of total time required to complete the test (seconds), improvement in this parameter requires minimizing the time recorded to complete the test.
2 secondary outcomes
The change in the six-minute walk test score.
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in the score of fall risk test .
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. - The data available is Case-by-case basis at the discretion of Primary Sponsor
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy Program and FES-Assisted Gait Training in people with Stroke, run by Umm Al-Qura University at 1 site in Saudi Arabia.
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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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 Saudi Arabia. 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?
Contact Ehab M Abd El Kafy, PhD (+966531698541, emkafy@uqu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the gait parameter (stride length). (time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).). The study lists 6 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 3 Nov 2026.