StrokeNCT07735676
ZEPU-AI1 Gait Robot Training Study (ZEPUAI1RCT)
A study testing ZEPU-AI1 Gait Training and Evaluation System and Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise) in people with Stroke and Spinal Cord Injuries (SCI), run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
Walking problems caused by stroke, spinal cord injury, or orthopedic surgery are common and can seriously limit a person's independence. Robotic-assisted gait training devices, which use a computer-controlled system to help patients practice standing and walking, have shown promise in improving strength, balance, and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stroke, Spinal Cord Injuries (SCI), Gait Disorders, Neurologic
- What is being tested?
- ZEPU-AI1 Gait Training and Evaluation System and Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBangladesh
- Study dates
- 14 May 2026to 7 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Lower-limb motor dysfunction from one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal-cord injury (neurological level T12 and below, ASIA C or D), (c) orthopedic surgery (e.g., knee/hip replacement) with persistent gait impairment >3 months post-surgery
- Age >18 and ≤60 years
- Able to provide informed consent and understand instructions
- Weight ≤100 kg and height within device adjustable range (per manufacturer specification)
- Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac/respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated DVT)
Who cannot join
- Complete spinal cord injury with inability to bear any weight
- Severe cognitive impairment (e.g., MMSE <24) preventing safe participation
- Severe spasticity (Modified Ashworth Scale >3) in lower limbs
- Unstable fractures, severe hip/knee contractures (>30° fixed flexion), or severe osteoarthritis requiring imminent surgery
- Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or implanted electronic device incompatible with robot sensors
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Safety and Efficacy of ZEPU AI1 Gait Training and Evaluation System Robot in Patients With Lower Limb Motor Weakness
Walking problems caused by stroke, spinal cord injury, or orthopedic surgery are common and can seriously limit a person's independence. Robotic-assisted gait training devices, which use a computer-controlled system to help patients practice standing and walking, have shown promise in improving strength, balance, and walking ability in other countries. However, this type of technology has not yet been carefully studied in Bangladesh.
This study will test a robotic gait training and evaluation device called ZEPU-AI1 in adults aged 19 to 60 years who have difficulty walking due to stroke, incomplete spinal cord injury, or gait problems following surgery. The main goals are to find out whether using this robotic device alongside standard physical therapy is feasible (practical to carry out) and safe, and to explore whether it helps improve walking speed, balance, muscle strength, and daily function compared with standard physical therapy alone.
Read more
Fifty-one participants took part (32 were originally planned; more were enrolled because additional eligible patients were available). Twenty-five received robot-assisted gait training three times a week for 12 weeks in addition to usual rehabilitation therapy, while 26 received usual rehabilitation therapy alone. Participants were assessed regularly using standard walking, balance, and strength tests over the 12-week period.
The results of this study will help doctors and researchers understand whether this robotic technology can be safely and effectively introduced into rehabilitation care in Bangladesh.
Read the detailed description
This is a single-site, pilot, randomized controlled trial evaluating the feasibility, safety, and preliminary efficacy of the ZEPU-AI1 Gait Training and Evaluation System, a computer-controlled robotic rehabilitation device, in adults with lower-limb motor dysfunction. The trial will be conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University (BMU), Dhaka, Bangladesh.
Fifty-one participants aged 19-60 years (planned enrolment 32; enrolment exceeded the target because additional eligible participants were available) with lower-limb motor dysfunction secondary to stroke (2-24 months post-onset), incomplete spinal cord injury (ASIA C or D, neurological level T12 or below), or persistent gait impairment following orthopedic surgery (>3 months post-surgery) were enrolled after screening against detailed inclusion/exclusion criteria (including device-specific anthropometric limits, medical stability, and absence of severe spasticity, unstable fractures, or cardiac contraindications). Participants were randomized into two parallel arms:
Intervention Arm (n=25): ZEPU-AI1 robot-assisted gait training combined with standard-of-care rehabilitation.
Control Arm (n=26): Standard-of-care rehabilitation alone.
The ZEPU-AI1 is a bilateral robotic exoskeleton system integrating a gait control unit (programmable hip range 30°-50°, knee range 50°-80°), a dynamic body-weight support mechanism (0-80 kg unloading), a motorized treadmill (0.1-3.5 km/h), and dedicated software providing real-time gait monitoring, spasticity detection, and automatic safety shutoff. Intervention-arm participants will undergo supervised training three times weekly for 12 weeks (36 sessions total), each session approximately 45 minutes, comprising warm-up, device donning, structured standing/gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down, with progressive adjustment of speed, body-weight support, and duration based on tolerance.
Primary outcomes are feasibility (recruitment, session adherence, device set-up/donning time, therapist competency time) and safety (incidence of device-related adverse events and serious adverse events, tolerability, dropout rate), assessed continuously throughout the intervention and at two-week intervals.
Secondary outcomes assess efficacy using standardized, validated instruments administered at baseline and two-week intervals over the 12-week period: 6-Minute Walk Test, Medical Research Council (MRC) Muscle Strength Scale, Functional Ambulation Category (FAC), Berg Balance Scale, Timed Up and Go (TUG) test, Modified Ashworth Scale (MAS), and a validated Bengali version of the EuroQol quality-of-life questionnaire. Usability and acceptability will be assessed via the Post-Study System Usability Questionnaire (PSSUQ) at study completion.
Data will be collected on standardized case report forms and entered into a password-protected, anonymized electronic database, with independent verification and monthly adverse-event review by a safety monitor not involved in training delivery. Analysis will follow an intention-to-treat approach (with a secondary per-protocol analysis), using descriptive
- Being tested
- ZEPU-AI1 Gait Training and Evaluation System, Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)
- Keywords
- Gait Training, Robotic Rehabilitation, Neurorehabilitation
- Medical subject headings
- Stroke, Spinal Cord Injuries, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEPU-AI1 Gait Training and Evaluation SystemDevice
Participants received robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System, a robotic device providing body-weight-supported, guided gait training. Training was delivered 3 times per week for 12 weeks (36 sessions total), approximately 45 minutes per session, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration were progressively adjusted based on participant tolerance and performance.
Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)Behavioural
Participants received individualized rehabilitation and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU. This standard-of-care rehabilitation program was tailored to each participant's functional status and needs, and was matched in overall therapeutic content and intensity across both study groups. It was delivered without any robotic-assisted device and represents the conventional-therapy component of care for individuals undergoing gait and mobility rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Augmented Rehabilitation Group | Experimental | Participants (n=25) received robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System in addition to standard-of-care rehabilitation. Training was delivered 3 times per week for 12 weeks (36 sessions total), each session approximately 45 minutes, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration were progressively adjusted based on participant tolerance and performance. Sessions were supervised by trained physiatrists and physiotherapists at the Robotic Rehabilitation Centre, BMU. Standard-of-care rehabilitation (individualized rehabilitation and exercise) continued in parallel. Receives: Device: ZEPU-AI1 Gait Training and Evaluation System; Behavioral: Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise) |
| Usual Care (Control) Group | Active comparator | Participants (n=26) received standard-of-care rehabilitation alone, without robotic-assisted gait training. This included an individualized rehabilitation regimen and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU, matched in overall therapeutic content to the conventional-therapy component received by the intervention group. Receives: Behavioral: Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Device-Related Adverse Events and Serious Adverse Events
Number and proportion of participants experiencing device-related adverse events (AEs) and serious adverse events (SAEs), including falls, skin breakdown/pressure sores, joint pain/injury, cardiovascular events, and fracture, during the intervention and follow-up period.
Measured: Baseline (T=0) through 12-week intervention period and follow-up, assessed every 2 weeks
Secondary outcomes (7)
Change in Six-Minute Walk Distance (6MWD)
Distance (in meters) walked in six minutes, a standardized measure of walking capacity, endurance, and functional mobility.
Measured: Baseline (T=0), every 2 weeks through 12 weeks
Change in Medical Research Council (MRC) Muscle Strength Scale
Manual muscle strength grading of lower-limb muscle groups using the Medical Research Council (MRC) Muscle Strength Scale, scored from 0 (no muscle contraction) to 5 (normal muscle strength), with higher scores indicating better muscle strength.
Measured: Baseline (T=0), every 2 weeks through 12 weeks
Change in Functional Ambulation Category (FAC) Score
Level of physical assistance required for ambulation assessed using the Functional Ambulation Category, a 6-point ordinal scale ranging from 0 (non-functional ambulation, unable to walk) to 5 (independent ambulation on any surface), with higher scores indicating better ambulatory function.
Measured: Baseline (T=0), every 2 weeks through 12 weeks
Change in Berg Balance Scale Score
Assessment of static and dynamic balance during functional tasks using the Berg Balance Scale, a clinician-administered scale ranging from 0 to 56, with higher scores indicating better balance.
Measured: Baseline (T=0), every 2 weeks through 12 weeks
Change in Timed Up and Go (TUG) Test
Time (in seconds) taken to rise from a chair, walk 3 meters, turn, walk back, and sit down; a measure of functional mobility and fall risk.
Measured: Baseline (T=0), every 2 weeks through 12 weeks
Change in Modified Ashworth Scale (MAS) for Lower-Limb Muscles
Clinical assessment of spasticity/muscle tone in the lower limbs using the Modified Ashworth Scale (MAS), scored from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension), with higher scores indicating greater spasticity (worse outcome).
Measured: Baseline (T=0), every 2 weeks through 12 weeks
Change in Quality of Life (EuroQol Questionnaire, Bengali Version)
Validated Bengali-language EuroQol (EQ-5D) questionnaire assessing health-related quality of life, a self-rated measure with a descriptive system score and index value where higher scores/values indicate better health-related quality of life.
Measured: Baseline (T=0), every 2 weeks through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start14 May 2026
- Primary completion15 Sep 2026
- Study completion7 Oct 2026
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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Md. Abdus Shakoor, Ph.D., Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735676
- Sponsor's protocol ID
- PR-1427
- Status last verified
- Oct 2026
- First submitted
- 26 Jul 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Efficacy of ZEPU AI1 Gait Training and Evaluation System Robot in Patients With Lower Limb Motor Weakness
- ClinicalTrials.gov ID
- NCT07735676
- Acronym / sponsor ID
- PR-1427
- Keywords
- Gait Training, Robotic Rehabilitation, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 14 May 2026 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 7 Oct 2026 (actual)
- First posted
- 30 Jul 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.
Walking problems caused by stroke, spinal cord injury, or orthopedic surgery are common and can seriously limit a person's independence. Robotic-assisted gait training devices, which use a computer-controlled system to help patients practice standing and walking, have shown promise in improving strength, balance, and walking ability in other countries. However, this type of technology has not yet been carefully studied in Bangladesh.
This study will test a robotic gait training and evaluation device called ZEPU-AI1 in adults aged 19 to 60 years who have difficulty walking due to stroke, incomplete spinal cord injury, or gait problems following surgery. The main goals are to find out whether using this robotic device alongside standard physical therapy is feasible (practical to carry out) and safe, and to explore whether it helps improve walking speed, balance, muscle strength, and daily function compared with standard physical therapy alone.
Fifty-one participants took part (32 were originally planned; more were enrolled because additional eligible patients were available). Twenty-five received robot-assisted gait training three times a week for 12 weeks in addition to usual rehabilitation therapy, while 26 received usual rehabilitation therapy alone. Participants were assessed regularly using standard walking, balance, and strength tests over the 12-week period.
The results of this study will help doctors and researchers understand whether this robotic technology can be safely and effectively introduced into rehabilitation care in Bangladesh.
Detailed description
This is a single-site, pilot, randomized controlled trial evaluating the feasibility, safety, and preliminary efficacy of the ZEPU-AI1 Gait Training and Evaluation System, a computer-controlled robotic rehabilitation device, in adults with lower-limb motor dysfunction. The trial will be conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University (BMU), Dhaka, Bangladesh.
Fifty-one participants aged 19-60 years (planned enrolment 32; enrolment exceeded the target because additional eligible participants were available) with lower-limb motor dysfunction secondary to stroke (2-24 months post-onset), incomplete spinal cord injury (ASIA C or D, neurological level T12 or below), or persistent gait impairment following orthopedic surgery (>3 months post-surgery) were enrolled after screening against detailed inclusion/exclusion criteria (including device-specific anthropometric limits, medical stability, and absence of severe spasticity, unstable fractures, or cardiac contraindications). Participants were randomized into two parallel arms:
Intervention Arm (n=25): ZEPU-AI1 robot-assisted gait training combined with standard-of-care rehabilitation.
Control Arm (n=26): Standard-of-care rehabilitation alone.
The ZEPU-AI1 is a bilateral robotic exoskeleton system integrating a gait control unit (programmable hip range 30°-50°, knee range 50°-80°), a dynamic body-weight support mechanism (0-80 kg unloading), a motorized treadmill (0.1-3.5 km/h), and dedicated software providing real-time gait monitoring, spasticity detection, and automatic safety shutoff. Intervention-arm participants will undergo supervised training three times weekly for 12 weeks (36 sessions total), each session approximately 45 minutes, comprising warm-up, device donning, structured standing/gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down, with progressive adjustment of speed, body-weight support, and duration based on tolerance.
Primary outcomes are feasibility (recruitment, session adherence, device set-up/donning time, therapist competency time) and safety (incidence of device-related adverse events and serious adverse events, tolerability, dropout rate), assessed continuously throughout the intervention and at two-week intervals.
Secondary outcomes assess efficacy using standardized, validated instruments administered at baseline and two-week intervals over the 12-week period: 6-Minute Walk Test, Medical Research Council (MRC) Muscle Strength Scale, Functional Ambulation Category (FAC), Berg Balance Scale, Timed Up and Go (TUG) test, Modified Ashworth Scale (MAS), and a validated Bengali version of the EuroQol quality-of-life questionnaire. Usability and acceptability will be assessed via the Post-Study System Usability Questionnaire (PSSUQ) at study completion.
Data will be collected on standardized case report forms and entered into a password-protected, anonymized electronic database, with independent verification and monthly adverse-event review by a safety monitor not involved in training delivery. Analysis will follow an intention-to-treat approach (with a secondary per-protocol analysis), using descriptive
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-Augmented Rehabilitation Group | Experimental | Device: ZEPU-AI1 Gait Training and Evaluation System, Behavioral: Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)Participants (n=25) received robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System in addition to standard-of-care rehabilitation. Training was delivered 3 times per week for 12 weeks (36 sessions total), each session approximately 45 minutes, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration were progressively adjusted based on participant tolerance and performance. Sessions were supervised by trained physiatrists and physiotherapists at the Robotic Rehabilitation Centre, BMU. Standard-of-care rehabilitation (individualized rehabilitation and exercise) continued in parallel. |
| Usual Care (Control) Group | Active comparator | Behavioral: Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)Participants (n=26) received standard-of-care rehabilitation alone, without robotic-assisted gait training. This included an individualized rehabilitation regimen and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU, matched in overall therapeutic content to the conventional-therapy component received by the intervention group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Lower-limb motor dysfunction from one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal-cord injury (neurological level T12 and below, ASIA C or D), (c) orthopedic surgery (e.g., knee/hip replacement) with persistent gait impairment >3 months post-surgery
- Age >18 and ≤60 years
- Able to provide informed consent and understand instructions
- Weight ≤100 kg and height within device adjustable range (per manufacturer specification)
- Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac/respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated DVT)
Key exclusion criteria (6 listed)
- Complete spinal cord injury with inability to bear any weight
- Severe cognitive impairment (e.g., MMSE <24) preventing safe participation
- Severe spasticity (Modified Ashworth Scale >3) in lower limbs
- Unstable fractures, severe hip/knee contractures (>30° fixed flexion), or severe osteoarthritis requiring imminent surgery
- Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or implanted electronic device incompatible with robot sensors
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 |
|---|---|---|
| ZEPU-AI1 Gait Training and Evaluation SystemParticipants received robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System, a robotic device providing body-weight-supported, guided gait training. Training was delivered 3 times per week for 12 weeks (36 sessions total), approximately 45 minutes per session, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration were progressively adjusted based on participant tolerance and performance. | Device | Robotic-Augmented Rehabilitation Group |
| Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)Participants received individualized rehabilitation and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU. This standard-of-care rehabilitation program was tailored to each participant's functional status and needs, and was matched in overall therapeutic content and intensity across both study groups. It was delivered without any robotic-assisted device and represents the conventional-therapy component of care for individuals undergoing gait and mobility rehabilitation. | Behavioural | Robotic-Augmented Rehabilitation Group, Usual Care (Control) Group |
Primary outcome
Incidence of Device-Related Adverse Events and Serious Adverse Events
Time frame: Baseline (T=0) through 12-week intervention period and follow-up, assessed every 2 weeks
Number and proportion of participants experiencing device-related adverse events (AEs) and serious adverse events (SAEs), including falls, skin breakdown/pressure sores, joint pain/injury, cardiovascular events, and fracture, during the intervention and follow-up period.
7 secondary outcomes
Change in Six-Minute Walk Distance (6MWD)
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Change in Medical Research Council (MRC) Muscle Strength Scale
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Change in Functional Ambulation Category (FAC) Score
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Change in Berg Balance Scale Score
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Change in Timed Up and Go (TUG) Test
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Change in Modified Ashworth Scale (MAS) for Lower-Limb Muscles
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Change in Quality of Life (EuroQol Questionnaire, Bengali Version)
Time frame: Baseline (T=0), every 2 weeks through 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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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 ZEPU-AI1 Gait Training and Evaluation System and Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise) in people with Stroke and Spinal Cord Injuries (SCI), run by Bangladesh Medical University at 1 site in Bangladesh.
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 6 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: finished, as of the sponsor's last update on 2 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 Bangladesh. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Device-Related Adverse Events and Serious Adverse Events (time frame: Baseline (T=0) through 12-week intervention period and follow-up, assessed every 2 weeks). 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 2 Nov 2026.