StrokeNCT04945395
Effect of Functional Electric Stimulation for Recovery of Dorsiflexion After Stroke
A study testing FES and Conventional training and AFO and Conventional training in people with Stroke and Ambulation Difficulty, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
The purpose of this project is to investigate the effect of functional electrical stimulation (FES) for recovery of dorsiflexion after stroke. It will be led from the University Department of Rehabilitation Medicine at Danderyd Hospital (RMDS) in collaboration with the MoveAbility Lab at KTH Royal Institute of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke, Ambulation Difficulty, Hemiplegia
- What is being tested?
- FES and Conventional training and AFO and Conventional training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 15 Aug 2021to Feb 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 participants with hemiplegia
- Dependence in ambulation (0- 4 according to the Functional Ambulation Categories)
- >= 50 points on the Trunc Control Test.
- Impaired dorsiflexion manifested as impaired voluntarily dorsiflex and to hold the ankle in a dorsiflexed position while sitting and for ambulatory participants: during swing phase and heel strike while walking as demonstrated by visual inspection during gait analysis performed by the physiotherapist.
- Recommended to be fitted with an ankle-foot orthosis (AFO) by an experienced physiotherapist.
- Able to understand study information and to give informed consent.
Who cannot join
- Contracture severely restricting gait movements at any lower limb joint
- Cardiovascular or other somatic condition incompatible with intensive gait training
- Notifiable infectious disease, contagious infections (e.g. Methicillin Resistant Staphylococcus Aureus (MRSA) or Extended Spectrum Beta Lactamase bacteria (ESBL)). - Not able to participate in the rehabilitation intervention due to behavioral disorder or psychiatric disease.
- The FES-system L300 Go ® should not be used if a the patient has a pacemaker, defibrillator or any electrical implant, a metallic implant in the affected leg, a cancerous lesion in the affected leg, a fracture or dislocation in the affected leg or if the affected leg is swollen, infected, or has inflamed areas or skin eruptions, such as phlebitis, thrombophlebitis, and varicose veins in the affected leg or if the patient is pregnant.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, 18288
Susanne Palmcrantz, PhD, susanne.palmcrantz@ki.se
About this study
Official title: The Effect of Using Functional Electric Stimulation for the Recovery of Dorsiflexion During Rehabilitation of Gait Function, in the Subacute Phase After Stroke- a Randomized Controlled Exploratory Study
The purpose of this project is to investigate the effect of functional electrical stimulation (FES) for recovery of dorsiflexion after stroke. It will be led from the University Department of Rehabilitation Medicine at Danderyd Hospital (RMDS) in collaboration with the MoveAbility Lab at KTH Royal Institute of Technology. Patients referred to RMDS for inpatient rehabilitation early after hemiparetic stroke will be included.
The overall aim is to explore how 4 weeks of training incorporating the FES-system (L300 Go System ® Bioness, Ottobock) effect function of the lower extremity, gait function and mobility when compared to conventional training only, in the subacute stage after stroke.
Read the detailed description
Participants will be included and allocated to either experimental group with training incorporating the FES-system and conventional training or to control group with conventional training only. Data will be collected before and after the intervention at RMDS and at the MoveAbility Lab. Physical tests and self-scored questionnaires of self-perceived aspects of functioning and disability will be performed at RMDS and gait analysis with 3D cameras and assessment of muscle function with EMG will be performed at the MoveAbilityLab. In addition, a short assessment of body function and activity will be performed weekly at RMDS by the therapist responsible for the rehabilitation intervention.
The experimental group will wear the FES-system L300 Go at all times when the patient is taking part in rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist. The settings will be adjusted by the employee from the technical company and/or the physiotherapist continuously during the intervention if needed. The system will register the distance and time accomplished during each session. Due to risk of skin irritation, if the system is overused in the beginning the experimental group will have access to an ankle-foot-orthosis too.
The control group will wear an ankle-foot-orthosis (AFO) and receive conventional training. The control group will wear a FES-system too, to record the distance and time accomplished during each session, but the system will not be active for stimulation.
- Conditions
- Stroke, Ambulation Difficulty, Hemiplegia
- Being tested
- FES and Conventional training, AFO and Conventional training
- Keywords
- Rehabilitation, Functional electrical stimulation, Walking, Stroke
- Medical subject headings
- Stroke, Mobility Limitation, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES and Conventional trainingDevice
The experimental group will be fitted with the Functional electrical stimulation system L300 Go to be used during 4 weeks of inpatient rehabilitation in the subacute phase after hemiplegic stroke. Settings will be adjusted continuously to enhance dorsiflexion of the affected foot during walking and mobility training.
AFO and Conventional trainingDevice
The control group will be fitted with an ankle-foot-orthosis (AFO) according to clinical practice to enhance dorsiflexion of the foot while taking part in conventional rehabilitation interventions during 4 weeks of inpatient rehabilitation including walking and mobility training in the subacute phase after hemiplegic stroke
| Study group | Role | What they receive |
|---|---|---|
| FES and conventional training | Experimental | The experimental group will wear the Functional electrical stimulation system L3100 Go for dorsiflexion of the ankle during conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist. Receives: Device: FES and Conventional training |
| AFO and Conventional training only | Active comparator | The control group will wear an ankle-foot-orthosis (AFO) to enhance dorsiflexion of the foot while taking part in conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist. Receives: Device: AFO and Conventional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Profile Score (GPS)
GPS is a single index measure that summarises the overall deviation of kinematic gait data relative to normative data. The GPS can be decomposed to provide the Gait Variable Score (GVS) (an index that measures single gait variable deviation), for nine key relevant kinematic variables. A larger GPS indicates greater deviation from normal gait
Measured: At baseline and after completion of the 4 week intervention to assess change.
Ankle Sagittal range (degrees)
Assesses range of motion in the ankle (plantarflexion from 0-50 degrees, dorsiflexion from 0-20 degrees)
Measured: At baseline and after completion of the 4 week intervention to assess change.
Ankle Positive work
Assesses the force at the ankle joint (J/kg) detected in gait laboratory
Measured: At baseline and after completion of the 4 week intervention to assess change.
Step length
Step length will be assessed in the gait laboratory with 3D gait analyses
Measured: At baseline and after completion of the 4 week intervention to assess change.
6 minutes walk test
Assesses walking endurance in meters walked
Measured: At baseline and after completion of the 4 week intervention to assess change.
Rated Perceived Exertion (RPE) Scale
Ratings (min 6, max 20) according to the RPE scale are made at the end of the 6 minutes walk test. A higher score indicates a higher degree of perceived exertion.
Measured: At baseline and after completion of the 4 week intervention to assess change.
Secondary outcomes (20)
The Montreal Cognitive Assessment (MoCa)
Assesses mental function (0p max impairment summed up to 30p no detected impairment)
Measured: At baseline and after completion of the 4 week intervention to assess change.
Fugl-Meyer score (FMA-LE)
Assesses sensory and movement related functions in the lower extremity (0p max impairment summed up to 86p max no detected impairment)
Measured: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Neuroflexor
Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton)
Measured: At baseline, weekly during the intervention, and after completion of the 4 week intervention to assess change.
Modified Ashworth scale 0-5
Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle)
Measured: At baseline, weekly during the intervention and after completion of the 4 week intervention, to assess change.
Passive range of motion in the lower extremity
Clinical assessment of range of motion with a goniometer
Measured: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Medical Research Council scale
Assesses muscle strength on a 6 point scale/muscle (0p max impairment summed up to 5p no impairment/muscle)
Measured: At baseline and after completion of the 4 week intervention
The Balance evaluation systems test (BEST-test)
Assesses postural control, incorporating bio-mechanical systems, limits of stability, anticipatory postural adjustment, automatic postural responses, sensory orientation, stability in gait (0p max impairment summed up to 108p no impairment)
Measured: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
The 10 meter walk test
Assesses gait speed
Measured: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
6 minutes walk test
Assesses walking endurance in meters walked
Measured: At baseline, weekly during the intervention and after the intervention to assess change
Rated Perceived Exertion (RPE) Scale
Ratings (min 6, max 20) according to the RPE scale are made at the end of the 6 minutes walk test.
Measured: At baseline, weekly during the intervention and after the intervention to assess change
Indirect Calorimetries
To assess energy expenditure based on respiratory gas exchange. Will be performed during the 6 minutes walk test.
Measured: At baseline and after the intervention to assess change
Electromyography (EMG)
EMG is used to measure muscle activation patterns during gait.
Measured: At baseline and after completion of the 4 week intervention to assess change.
Walking impact scale (MSWS-12 S)
Assesses self-perceived limitations in walking (12p no impairments summed up to 60p max impairment)
Measured: At baseline and after completion of the 4 week intervention to assess change.
The Functional Ambulation Categories (FAC)
Assesses independence in walking (0p nonfunctional, 5p independent) Total score 0-5p
Measured: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Falls Efficacy Scale (FES-S)
Assesses self perceived balance in every day life activities rated on a 11 point scale (0p not safe at all 10p completely safe). Total score: 0- 130 p
Measured: At baseline and after completion of the 4 week intervention to assess change.
Barthel Index
Assesses independence in mobility and personal care (0p dependent 10/15p independent) Total score 0-100p
Measured: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Eq-5d-5l
Assesses self perceived health related quality of life in five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and on a vertical visual analogue scale. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension (1 = no problem, 5 = extreme problems). The vertical visual analogue scale is graded from 0-100 (0 = the worst health you can imagine 100 = the best health you can imagine).
Measured: At baseline and after completion of the 4 week intervention to assess change.
A study specific questionnaire - a questionnaire for the experimental group
A questionnaire with 11 questions assessing the patients experience of participating in the study and the use of the FES-system. The patient rates on a 10 graded scale (0 = not at all, 10 = very much): the information given about the study, the experience, usability and comfort of using the system, eventual pain, skin problems and technical problems with the system and experience of eventual benefits from having used the system.
Measured: After completion of the 4 week intervention
Distance accomplished during each training session
The FES-system will collect this data to assess training intensity
Measured: Daily during the intervention
Time accomplished during each training session
The FES-system will collect this data to assess training intensity
Measured: Daily during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start15 Aug 2021
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KTH Royal Institute of Technology
- Responsible party
- Principal investigator, Susanne Palmcrantz, Danderyd Hospital
- Investigators
- Susanne Palmcrantz, PhD, Principal investigator, Dep of Clinical Sciences, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945395
- Sponsor's protocol ID
- FES-study
- Status last verified
- Jan 2023
- First submitted
- 3 Jun 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Functional Electric Stimulation for the Recovery of Dorsiflexion During Rehabilitation of Gait Function, in the Subacute Phase After Stroke- a Randomized Controlled Exploratory Study
- ClinicalTrials.gov ID
- NCT04945395
- Acronym / sponsor ID
- FES-study
- Conditions
- Stroke, Ambulation Difficulty, Hemiplegia
- Keywords
- Rehabilitation, Functional electrical stimulation, Walking, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- KTH Royal Institute of Technology
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to investigate the effect of functional electrical stimulation (FES) for recovery of dorsiflexion after stroke. It will be led from the University Department of Rehabilitation Medicine at Danderyd Hospital (RMDS) in collaboration with the MoveAbility Lab at KTH Royal Institute of Technology. Patients referred to RMDS for inpatient rehabilitation early after hemiparetic stroke will be included.
The overall aim is to explore how 4 weeks of training incorporating the FES-system (L300 Go System ® Bioness, Ottobock) effect function of the lower extremity, gait function and mobility when compared to conventional training only, in the subacute stage after stroke.
Detailed description
Participants will be included and allocated to either experimental group with training incorporating the FES-system and conventional training or to control group with conventional training only. Data will be collected before and after the intervention at RMDS and at the MoveAbility Lab. Physical tests and self-scored questionnaires of self-perceived aspects of functioning and disability will be performed at RMDS and gait analysis with 3D cameras and assessment of muscle function with EMG will be performed at the MoveAbilityLab. In addition, a short assessment of body function and activity will be performed weekly at RMDS by the therapist responsible for the rehabilitation intervention.
The experimental group will wear the FES-system L300 Go at all times when the patient is taking part in rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist. The settings will be adjusted by the employee from the technical company and/or the physiotherapist continuously during the intervention if needed. The system will register the distance and time accomplished during each session. Due to risk of skin irritation, if the system is overused in the beginning the experimental group will have access to an ankle-foot-orthosis too.
The control group will wear an ankle-foot-orthosis (AFO) and receive conventional training. The control group will wear a FES-system too, to record the distance and time accomplished during each session, but the system will not be active for stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| FES and conventional training | Experimental | Device: FES and Conventional trainingThe experimental group will wear the Functional electrical stimulation system L3100 Go for dorsiflexion of the ankle during conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist. |
| AFO and Conventional training only | Active comparator | Device: AFO and Conventional trainingThe control group will wear an ankle-foot-orthosis (AFO) to enhance dorsiflexion of the foot while taking part in conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 20 participants with hemiplegia
- Dependence in ambulation (0- 4 according to the Functional Ambulation Categories)
- >= 50 points on the Trunc Control Test.
- Impaired dorsiflexion manifested as impaired voluntarily dorsiflex and to hold the ankle in a dorsiflexed position while sitting and for ambulatory participants: during swing phase and heel strike while walking as demonstrated by visual inspection during gait analysis performed by the physiotherapist.
- Recommended to be fitted with an ankle-foot orthosis (AFO) by an experienced physiotherapist.
Key exclusion criteria (4 listed)
- Contracture severely restricting gait movements at any lower limb joint
- Cardiovascular or other somatic condition incompatible with intensive gait training
- Notifiable infectious disease, contagious infections (e.g. Methicillin Resistant Staphylococcus Aureus (MRSA) or Extended Spectrum Beta Lactamase bacteria (ESBL)). - Not able to participate in the rehabilitation intervention due to behavioral disorder or psychiatric disease.
- The FES-system L300 Go ® should not be used if a the patient has a pacemaker, defibrillator or any electrical implant, a metallic implant in the affected leg, a cancerous lesion in the affected leg, a fracture or dislocation in the affected leg or if the affected leg is swollen, infected, or has inflamed areas or skin eruptions, such as phlebitis, thrombophlebitis, and varicose veins in the affected leg or if the patient is pregnant.
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 |
|---|---|---|
| FES and Conventional trainingThe experimental group will be fitted with the Functional electrical stimulation system L300 Go to be used during 4 weeks of inpatient rehabilitation in the subacute phase after hemiplegic stroke. Settings will be adjusted continuously to enhance dorsiflexion of the affected foot during walking and mobility training. | Device | FES and conventional training |
| AFO and Conventional trainingThe control group will be fitted with an ankle-foot-orthosis (AFO) according to clinical practice to enhance dorsiflexion of the foot while taking part in conventional rehabilitation interventions during 4 weeks of inpatient rehabilitation including walking and mobility training in the subacute phase after hemiplegic stroke | Device | AFO and Conventional training only |
Primary outcome
Gait Profile Score (GPS)
Time frame: At baseline and after completion of the 4 week intervention to assess change.
GPS is a single index measure that summarises the overall deviation of kinematic gait data relative to normative data. The GPS can be decomposed to provide the Gait Variable Score (GVS) (an index that measures single gait variable deviation), for nine key relevant kinematic variables. A larger GPS indicates greater deviation from normal gait
Ankle Sagittal range (degrees)
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Assesses range of motion in the ankle (plantarflexion from 0-50 degrees, dorsiflexion from 0-20 degrees)
Ankle Positive work
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Assesses the force at the ankle joint (J/kg) detected in gait laboratory
Step length
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Step length will be assessed in the gait laboratory with 3D gait analyses
6 minutes walk test
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Assesses walking endurance in meters walked
Rated Perceived Exertion (RPE) Scale
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Ratings (min 6, max 20) according to the RPE scale are made at the end of the 6 minutes walk test. A higher score indicates a higher degree of perceived exertion.
20 secondary outcomes
The Montreal Cognitive Assessment (MoCa)
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Fugl-Meyer score (FMA-LE)
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Neuroflexor
Time frame: At baseline, weekly during the intervention, and after completion of the 4 week intervention to assess change.
Modified Ashworth scale 0-5
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention, to assess change.
Passive range of motion in the lower extremity
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Medical Research Council scale
Time frame: At baseline and after completion of the 4 week intervention
The Balance evaluation systems test (BEST-test)
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
The 10 meter walk test
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
6 minutes walk test
Time frame: At baseline, weekly during the intervention and after the intervention to assess change
Rated Perceived Exertion (RPE) Scale
Time frame: At baseline, weekly during the intervention and after the intervention to assess change
Indirect Calorimetries
Time frame: At baseline and after the intervention to assess change
Electromyography (EMG)
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Walking impact scale (MSWS-12 S)
Time frame: At baseline and after completion of the 4 week intervention to assess change.
The Functional Ambulation Categories (FAC)
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Falls Efficacy Scale (FES-S)
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Barthel Index
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Eq-5d-5l
Time frame: At baseline and after completion of the 4 week intervention to assess change.
A study specific questionnaire - a questionnaire for the experimental group
Time frame: After completion of the 4 week intervention
Distance accomplished during each training session
Time frame: Daily during the intervention
Time accomplished during each training session
Time frame: Daily during the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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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.
Susanne Palmcrantz, PhD principal investigator
Dep of Clinical Sciences, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES and Conventional training and AFO and Conventional training in people with Stroke and Ambulation Difficulty, run by Danderyd Hospital at 1 site in Sweden.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanne Palmcrantz, PhD (004681235000, susanne.palmcrantz@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Profile Score (GPS) (time frame: At baseline and after completion of the 4 week intervention to assess change.). 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 9 Feb 2023.