TelemedicineNCT04434313
Treatment of Hemiparetic Gait Impairments Using Telehealth With the Moterum iStride Solution™
A study testing Delivery of iStride™ device gait treatment using telemedicine in people with Telemedicine and Gait, Hemiplegic, run by Moterum Technologies, Inc. at 1 site in United States.
Trial summary
The objective of this research is to investigate the feasibility of delivering gait treatment using the Moterum iStride Solution™ to individuals with hemiparetic gait impairments using a telemedicine modality, the Moterum Digital Platform. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Telemedicine, Gait, Hemiplegic, Gait Disorders, Neurologic
- What is being tested?
- Delivery of iStride™ device gait treatment using telemedicine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2020to 21 Dec 2020
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-80
- Caregiver support. The caregiver should be an adult over the age of 18 without physical or cognitive limitations which would prohibit them from being able to provide appropriate assistance to the device user
- Hemiparesis
- If hemiparesis is due to a stroke, the stroke occurred at least 3 months prior to enrollment
- Gait asymmetry
- Able to walk independently with or without a cane or hemiwalker, (Modified Rankin Score 3 or less)
Show all 9Show fewer
- No evidence of severe cognitive impairment that would interfere with understanding the instructions
- At least 25 feet of walking space (does not need to be a straight line)
- Weight does not exceed 275lbs
Who cannot join
- Uncontrolled seizures
- Metal implants (stents, clips, pacemaker)
- Pregnancy
- Chronic Obstructive Pulmonary Disease
- Uncontrolled blood pressure
- Myocardial infarction within the last 180 days
Show all 9Show fewer
- Cannot rely on a rolling walker for ambulation
- Severe ataxia interfering with safety on the device
- Previously diagnosed vestibular ear issues interfering with safety on the device
Trial locations and contacts
1 site in 1 country.
United States1 site
Moterum Technologies, Inc. (study location: homes throughout United States)
Salt Lake City, Utah, 84115
About this study
The objective of this research is to investigate the feasibility of delivering gait treatment using the Moterum iStride Solution™ to individuals with hemiparetic gait impairments using a telemedicine modality, the Moterum Digital Platform.
Read the detailed description
Hemiparesis, a common disabling consequence of stroke and other neurologic conditions, can lead to abnormal gait function often characterized by asymmetric patterns and decreased gait speed. A large percentage of stroke survivors, up to 70%, experience gait dysfunction, which can lead to reduced activity levels, limited community participation, and contribute to an increased risk of falls. Effective interventions to treat gait dysfunction are essential to reduce disability for these individuals.
The iStride™ gait device, initially designed to mimic the symmetry-improving mechanism of a split-belt treadmill, was developed to treat asymmetric gait impairments in stroke survivors. Unlike many currently available gait treatment devices, the iStride™ device is portable, therefore allowing gait treatment to occur overground and from the home environment. Training in natural environments is believed to enhance the transfer of learning as well as enable long-term training. Previously published studies with the iStride™ device demonstrate its ability to beneficially improve functional gait parameters, gait speed, and reduce fall risk in both clinical and home settings.
To monitor improvement in gait function, the device is paired with patented iStride sensors™. The combined system, the Moterum iStride Solution™, is currently being used by stroke survivors in the home environment. In the current delivery model, users are provided instruction and training from physical therapists in clinical settings before using the device in their home environment under the supervision of a Moterum staff member. User feedback has led to the exploration of novel methods to deliver device treatment remotely. [Additionally, the need for remote treatment has increased in urgency with the onset of the coronavirus pandemic and social distancing guidelines.]
In this study, treatment with the iStride™ will be adapted to remote delivery using a telemedicine platform, the Moterum Digital Platform. A screening process will be implemented to guide participant selection and identify individuals likely to be successful with remote treatment delivery using the telemedicine modality. This process consists of an initial eligibility criteria review followed by a physical therapist video review of participant walking patterns.
Once enrolled in the clinical trial, participants will receive study-related equipment including the iStride™ device, Moterum iStride Hub and Sensors™, and a pre-measured strap for gait testing. They will be instructed in the download of the Moterum Digital Platform which will serve as the telemedicine modality for subsequent communication. Participants and their caregivers will be provided with instructional videos as well as therapist training on study procedures using video calls through the telemedicine platform. Instruction will include telemedicine portal navigation, iStride™ fitting (donning/doffing), mobility and walking guidelines with iStride™ device, assessment performance, environmental considerations, safety precautions, and caregiver guidelines and responsibilities.
Changes to gait patterns will be assessed using specialized gait sensors and functional outcome measures before, during, and after the treatment. Caregivers will be trained in the performance of these outcome measures which can be overseen by physical therapists through video conferencing.
Feasibility, compliance, and safety of the delivery method will be investigated throughout the trial using prompted questions within the Moterum Digital Platform and integrated forms to be completed by the participant and/or caregiver. After treatment is completed, participants and their caregivers will be surveyed to obtain feedback regarding usability, satisfaction, and sentiments regarding the remote delivery model.
- Conditions
- Telemedicine, Gait, Hemiplegic, Gait Disorders, Neurologic, Stroke, Orthotic Devices, Gait Analysis
- Being tested
- Delivery of iStride™ device gait treatment using telemedicine
- Keywords
- iStride, Telehealth, Telerehabilitation, Gait Speed
- Medical subject headings
- Gait Disorders, Neurologic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery of iStride™ device gait treatment using telemedicineDevice
The gait device used in this study mimics the actions of the split-belt treadmill but can be used during overground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking. This research aims to adapt the delivery mechanism of treatment with the iStride™ device to include telemedicine. The telemedicine platform of reference in this study, the Moterum Digital Platform, is an integrated therapeutic platform which offers an activity library, real-time video conferencing, and outcomes tracking. Our primary study objective is to determine if telemedicine is a safe and feasible delivery method for treatment with the iStride ™ gait device.
| Study group | Role | What they receive |
|---|---|---|
| Delivery of iStride™ device gait treatment using telemedicine | Experimental | Treatment with the gait device will be adapted to remote delivery using the telemedicine platform. Participants and caregivers will be guided through an adapted treatment protocol remotely by physical therapists. Training will include platform navigation, device instruction, treatment guidelines, safety precautions, and assessment performance. Understanding will be verified through a caregiver quiz.
Gait patterns will be monitored before, during, and after treatment using gait sensors and outcome measures. Assessments include the 10-Meter Walk Test, Six Minute Walk Test, Timed Up and Go Test, Geriatric Depression Scale, Activities-Specific Balance Confidence Scale, and Stroke Impact Scale-16. Treatment will consist of 12 sessions of walking on the device for a goal of 30 minutes per session. Assessments will be repeated one-week, one-month, three-months, six-months, and 12-months after treatment. Feasibility and safety of the delivery method will be measured throughout the trial. Receives: Device: Delivery of iStride™ device gait treatment using telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of safely implementing the treatment protocol
The described delivery method includes using remote physical therapist treatment oversight and physical supervision of treatment activities by trained caregivers. Due to the inclusion criteria, patients already have some risk of falls and need for assistance while walking. The caregivers will record assistance levels provided during treatment. Any adverse events will be immediately reported and reviewed. The remote physical therapists will regularly review assistance levels to ensure the participant is requiring an appropriate level of assistance. The feasibility of safely delivering treatment will be assessed by two measures: (a) the daily safety rate, defined as the percentage of days an adverse event occurred out of the total number of treatment days, and (2) assistance required and adverse events experienced for each participant, compared to the group, and compared to our prior research.
Measured: Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment).
Achievability of telemedicine delivery protocol
The achievability of this treatment delivery method will be assessed by measuring participant compliance to the protocol tasks. These tasks include scheduled treatment sessions, functional and psychosocial outcome measures, and sensor-based activities. Achievability will be defined as the percentage of completed protocol activities out of the total scheduled activities.
Measured: Determined within one week after the final follow-up assessment (12-month follow-up) is completed. The 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period.
Secondary outcomes (2)
Feasibility of screening criteria
To enroll patients via telemedicine, the eligibility criteria will be assessed with an additional video gait review performed by physical therapists. The feasibility of screening patients at a distance will be assessed by measuring screening performance, defined as the percentage of enrolled subjects who are removed from the study after later being deemed ineligible (for example, gait is not asymmetric or hemiparetic but appeared so on video, or patient cannot walk independently, etc.) out of all enrolled subjects.
Measured: Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment).
Stakeholder Acceptability
Participant and caregiver feedback will be necessary to determine preferences and sentiments regarding the delivery method including technology management, training procedures, protocol activities, adequacy of caregiver and therapist support, device benefit, and overall satisfaction with procedures. Feedback will be gathered through a questionnaire using five-point Likert scales and open-ended questions. Questionnaires will be provided after completion of outcome measures at the final, 12-month follow-up assessment. Acceptability will be determined through percentage of positive responses out of the total questionnaire items.
Measured: Determined within one week after the final follow-up assessment (12-month follow-up) is completed. The 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start20 Apr 2020
- Primary completion19 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moterum Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen T. Shultz, PT, DPT, OCS, Principal investigator, Wingate University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434313
- Sponsor's protocol ID
- MOT-TELE-2020-04-00
- Status last verified
- Sep 2022
- First submitted
- 3 Jun 2020
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Reed KB, Handzic, Ismet, Inventor; University of South Florida, assignee. Gait Altering Shoes. US patent 9,295,302. March 29, 2016, 2016.
Handzic I, Vasudevan E, Reed KB. Developing a Gait Enhancing Mobile Shoe to Alter Over-Ground Walking Coordination. IEEE Int Conf Robot Autom. 2012 May;2012:4124-4129. doi: 10.1109/ICRA.2012.6225346.
PubMed 23484067Handzic I, Barno EM, Vasudevan EV, Reed KB. Design and Pilot Study of a Gait Enhancing Mobile Shoe. Paladyn. 2011 Dec 1;2(4):10.2478/s13230-012-0010-7. doi: 10.2478/s13230-012-0010-7.
PubMed 24371521Kim SH, Huizenga DE, Handzic I, Ditwiler RE, Lazinski M, Ramakrishnan T, Bozeman A, Rose DZ, Reed KB. Relearning functional and symmetric walking after stroke using a wearable device: a feasibility study. J Neuroeng Rehabil. 2019 Aug 28;16(1):106. doi: 10.1186/s12984-019-0569-x.
PubMed 31455358Darcy B, Rashford L, Shultz ST, Tsai NT, Huizenga D, Reed KB, Bamberg SJM. Gait Device Treatment Using Telehealth for Individuals With Stroke During the COVID-19 Pandemic: Nonrandomized Pilot Feasibility Study. JMIR Form Res. 2023 May 19;7:e43008. doi: 10.2196/43008.
PubMed 37204830
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hemiparetic Gait Impairments Using Telehealth With the Moterum iStride Solution™
- ClinicalTrials.gov ID
- NCT04434313
- Acronym / sponsor ID
- MOT-TELE-2020-04-00
- Conditions
- Telemedicine, Gait, Hemiplegic, Gait Disorders, Neurologic, Stroke, Orthotic Devices, Gait Analysis
- Keywords
- iStride, Telehealth, Telerehabilitation, Gait Speed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Moterum Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 16 Jun 2020 (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 objective of this research is to investigate the feasibility of delivering gait treatment using the Moterum iStride Solution™ to individuals with hemiparetic gait impairments using a telemedicine modality, the Moterum Digital Platform.
Detailed description
Hemiparesis, a common disabling consequence of stroke and other neurologic conditions, can lead to abnormal gait function often characterized by asymmetric patterns and decreased gait speed. A large percentage of stroke survivors, up to 70%, experience gait dysfunction, which can lead to reduced activity levels, limited community participation, and contribute to an increased risk of falls. Effective interventions to treat gait dysfunction are essential to reduce disability for these individuals.
The iStride™ gait device, initially designed to mimic the symmetry-improving mechanism of a split-belt treadmill, was developed to treat asymmetric gait impairments in stroke survivors. Unlike many currently available gait treatment devices, the iStride™ device is portable, therefore allowing gait treatment to occur overground and from the home environment. Training in natural environments is believed to enhance the transfer of learning as well as enable long-term training. Previously published studies with the iStride™ device demonstrate its ability to beneficially improve functional gait parameters, gait speed, and reduce fall risk in both clinical and home settings.
To monitor improvement in gait function, the device is paired with patented iStride sensors™. The combined system, the Moterum iStride Solution™, is currently being used by stroke survivors in the home environment. In the current delivery model, users are provided instruction and training from physical therapists in clinical settings before using the device in their home environment under the supervision of a Moterum staff member. User feedback has led to the exploration of novel methods to deliver device treatment remotely. [Additionally, the need for remote treatment has increased in urgency with the onset of the coronavirus pandemic and social distancing guidelines.]
In this study, treatment with the iStride™ will be adapted to remote delivery using a telemedicine platform, the Moterum Digital Platform. A screening process will be implemented to guide participant selection and identify individuals likely to be successful with remote treatment delivery using the telemedicine modality. This process consists of an initial eligibility criteria review followed by a physical therapist video review of participant walking patterns.
Once enrolled in the clinical trial, participants will receive study-related equipment including the iStride™ device, Moterum iStride Hub and Sensors™, and a pre-measured strap for gait testing. They will be instructed in the download of the Moterum Digital Platform which will serve as the telemedicine modality for subsequent communication. Participants and their caregivers will be provided with instructional videos as well as therapist training on study procedures using video calls through the telemedicine platform. Instruction will include telemedicine portal navigation, iStride™ fitting (donning/doffing), mobility and walking guidelines with iStride™ device, assessment performance, environmental considerations, safety precautions, and caregiver guidelines and responsibilities.
Changes to gait patterns will be assessed using specialized gait sensors and functional outcome measures before, during, and after the treatment. Caregivers will be trained in the performance of these outcome measures which can be overseen by physical therapists through video conferencing.
Feasibility, compliance, and safety of the delivery method will be investigated throughout the trial using prompted questions within the Moterum Digital Platform and integrated forms to be completed by the participant and/or caregiver. After treatment is completed, participants and their caregivers will be surveyed to obtain feedback regarding usability, satisfaction, and sentiments regarding the remote delivery model.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delivery of iStride™ device gait treatment using telemedicine | Experimental | Device: Delivery of iStride™ device gait treatment using telemedicineTreatment with the gait device will be adapted to remote delivery using the telemedicine platform. Participants and caregivers will be guided through an adapted treatment protocol remotely by physical therapists. Training will include platform navigation, device instruction, treatment guidelines, safety precautions, and assessment performance. Understanding will be verified through a caregiver quiz. Gait patterns will be monitored before, during, and after treatment using gait sensors and outcome measures. Assessments include the 10-Meter Walk Test, Six Minute Walk Test, Timed Up and Go Test, Geriatric Depression Scale, Activities-Specific Balance Confidence Scale, and Stroke Impact Scale-16. Treatment will consist of 12 sessions of walking on the device for a goal of 30 minutes per session. Assessments will be repeated one-week, one-month, three-months, six-months, and 12-months after treatment. Feasibility and safety of the delivery method will be measured throughout the trial. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 21-80
- Caregiver support. The caregiver should be an adult over the age of 18 without physical or cognitive limitations which would prohibit them from being able to provide appropriate assistance to the device user
- Hemiparesis
- If hemiparesis is due to a stroke, the stroke occurred at least 3 months prior to enrollment
- Gait asymmetry
Key exclusion criteria (9 listed)
- Uncontrolled seizures
- Metal implants (stents, clips, pacemaker)
- Pregnancy
- Chronic Obstructive Pulmonary Disease
- Uncontrolled blood pressure
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 |
|---|---|---|
| Delivery of iStride™ device gait treatment using telemedicineThe gait device used in this study mimics the actions of the split-belt treadmill but can be used during overground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking. This research aims to adapt the delivery mechanism of treatment with the iStride™ device to include telemedicine. The telemedicine platform of reference in this study, the Moterum Digital Platform, is an integrated therapeutic platform which offers an activity library, real-time video conferencing, and outcomes tracking. Our primary study objective is to determine if telemedicine is a safe and feasible delivery method for treatment with the iStride ™ gait device. | Device | Delivery of iStride™ device gait treatment using telemedicine |
Primary outcome
Feasibility of safely implementing the treatment protocol
Time frame: Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment).
The described delivery method includes using remote physical therapist treatment oversight and physical supervision of treatment activities by trained caregivers. Due to the inclusion criteria, patients already have some risk of falls and need for assistance while walking. The caregivers will record assistance levels provided during treatment. Any adverse events will be immediately reported and reviewed. The remote physical therapists will regularly review assistance levels to ensure the participant is requiring an appropriate level of assistance. The feasibility of safely delivering treatment will be assessed by two measures: (a) the daily safety rate, defined as the percentage of days an adverse event occurred out of the total number of treatment days, and (2) assistance required and adverse events experienced for each participant, compared to the group, and compared to our prior research.
Achievability of telemedicine delivery protocol
Time frame: Determined within one week after the final follow-up assessment (12-month follow-up) is completed. The 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period.
The achievability of this treatment delivery method will be assessed by measuring participant compliance to the protocol tasks. These tasks include scheduled treatment sessions, functional and psychosocial outcome measures, and sensor-based activities. Achievability will be defined as the percentage of completed protocol activities out of the total scheduled activities.
2 secondary outcomes
Feasibility of screening criteria
Time frame: Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment).
Stakeholder Acceptability
Time frame: Determined within one week after the final follow-up assessment (12-month follow-up) is completed. The 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period.
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 7 Sep 2022.
- BackgroundReed KB, Handzic, Ismet, Inventor; University of South Florida, assignee. Gait Altering Shoes. US patent 9,295,302. March 29, 2016, 2016.
- Background: PubMed 23484067Handzic I, Vasudevan E, Reed KB. Developing a Gait Enhancing Mobile Shoe to Alter Over-Ground Walking Coordination. IEEE Int Conf Robot Autom. 2012 May;2012:4124-4129. doi: 10.1109/ICRA.2012.6225346.
- Background: PubMed 24371521Handzic I, Barno EM, Vasudevan EV, Reed KB. Design and Pilot Study of a Gait Enhancing Mobile Shoe. Paladyn. 2011 Dec 1;2(4):10.2478/s13230-012-0010-7. doi: 10.2478/s13230-012-0010-7.
- Background: PubMed 31455358Kim SH, Huizenga DE, Handzic I, Ditwiler RE, Lazinski M, Ramakrishnan T, Bozeman A, Rose DZ, Reed KB. Relearning functional and symmetric walking after stroke using a wearable device: a feasibility study. J Neuroeng Rehabil. 2019 Aug 28;16(1):106. doi: 10.1186/s12984-019-0569-x.
- Derived from this study: PubMed 37204830Darcy B, Rashford L, Shultz ST, Tsai NT, Huizenga D, Reed KB, Bamberg SJM. Gait Device Treatment Using Telehealth for Individuals With Stroke During the COVID-19 Pandemic: Nonrandomized Pilot Feasibility Study. JMIR Form Res. 2023 May 19;7:e43008. doi: 10.2196/43008.
- Individual participant dataSharing planned: No
Related trials for Telemedicine
Recruiting
Tele-HOPE: A Telehealth Pharmacist Opioid Patient Education Pilot Study
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Active, not recruiting
Enhancing Telemedicine for T2D
Type 2 Diabetes
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
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.
Stephen T. Shultz, PT, DPT, OCS principal investigator
Wingate University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery of iStride™ device gait treatment using telemedicine in people with Telemedicine and Gait, Hemiplegic, run by Moterum Technologies, Inc. at 1 site in United States.
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 9 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 7 Sep 2022. 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 United States. 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?
Feasibility of safely implementing the treatment protocol (time frame: Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04434313, which also lists 5 linked publications.
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 7 Sep 2022.