PD - Parkinson's DiseaseNCT06598878
AR Gait Training for Parkinson's Disease
A study testing AR gait training in people with PD - Parkinson's Disease, run by Chang Gung University at 1 site in Taiwan.
Trial summary
Gait disorders in Parkinson's disease (PD), particularly in complex environments or under stress, present challenges for accurate evaluation and classification, such as in cases of freezing of gait. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- PD - Parkinson's Disease
- What is being tested?
- AR gait training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Oct 2024to Jul 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson disease.
Who cannot join
- Musculoskeletal injuries on legs
- Osteoporosis.
- Any peripheral or central nervous system injury or disease patients.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, 333
Ya-Ju Chang, PhD, 88632118800 ext. 5515, yjchang@mail.cgu.edu.tw
About this study
Official title: Effect of AR Environment Stimulation on Proactive and Reactive Modulation of Gait in Individuals With Parkinson Disease
Gait disorders in Parkinson's disease (PD), particularly in complex environments or under stress, present challenges for accurate evaluation and classification, such as in cases of freezing of gait. Traditional clinical and laboratory settings often fail to replicate the complexity needed for precise classification, making effective rehabilitation difficult. This study aims to address these challenges by developing an augmented reality (AR)-based environment that mimics real-world stressors and dynamically adapts to the patient's condition. The AR system is designed to facilitate individualized gait training and rehabilitation by modifying environmental difficulty based on real-time feedback from gait performance and stress levels.
Building on Gentile's taxonomy of tasks, the investigators have incorporated PD-specific factors, such as cognitive dual tasks, into our environment classification system. Preliminary results suggest that this system effectively elicits varying gait and heart rate variability (HRV) responses, indicating different stress levels.
This trial will further test the AR environment's ability to classify patients based on their responses to complex, interactive environments, while also investigating the effects of adaptive AR-based gait training on both gait and stress management in individuals with PD.
Read the detailed description
Gait disorder in Parkinson's disease (PD), has been reported to be related to complex environments and stress situations. To perform precise evaluation on gait disorder, such as freezing of gait, is not easy in clinical and/or lab environment, causing the difficulty to make accurate classification of gait disorder. Designing a standard environment stimulation paradigm helps to promote precise classification of gait disorders. Monitoring the stress situation that causes gait disorder, and dynamically modifying environment assists in the facilitation of effective individualized gait rehabilitation for PD patients.
Although Gentile's taxonomy of tasks provides a structure to examine the complexity of movement task in accordance with environmental context, this taxonomy and environmental context does not specifically reflects PD movement problems. In this on-going project, the investigators developed an environment classification system based on Gentile's taxonomy, but added PD related factors, such as cognitive dual task to meet the needs of this population. Our preliminary results showed that this novel classification successfully induced different levels of gait and HRV responses, suggesting different stress situations.
For the following, the investigators plan to apply the Augment reality (AR) technique to produce standard interactive testing and training environment. AR allows us to mimic complex environments in lab for evaluation and rehabilitation. In addition, AR could interactively change the difficulty of environment according to the patients'gait and stress situation which is important for developing effective personal rehabilitation program
The purposes for this project are as follows:
- Test the AR environment stimulation on classifying patients and establish the relationships among challenging AR environment, pressure, and gait
- Investigate the effects of interactive AR gait training on gait and stress for individuals with PD.
- Conditions
- PD - Parkinson's Disease
- Being tested
- AR gait training
- Keywords
- Augmented Reality, Gait Taining, Heart Rate Variability (HRV)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR gait trainingProcedure or surgery
Participants will walk on a pathway projected in augmented reality (AR), following the instructions provided on the pathway Each session will last for 60 minutes, conducted three times per week, over a period of six weeks.
| Study group | Role | What they receive |
|---|---|---|
| PD patients | Experimental | AR gait training Receives: Procedure: AR gait training |
| PD patients (Control) | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Speed
The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Measured: Baseline, 6 weeks, 8 weeks
Step Length
The linear distance between the two ankles, typically expressed in centimeter(cm).
Measured: Baseline, 6 weeks, 8 weeks
Step Time
The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.
Measured: Baseline, 6 weeks, 8 weeks
Time-Domain Index of Heart Rate Variability (HRV)：Standard deviation of RR intervals (SDRR)
SDRR is the standard deviation of all recorded RR intervals (the time between successive heartbeats) over a specific period, usually expressed in milliseconds. This measure captures the total variability in heart rate, representing the physiological responses to a variety of internal and external stimuli. High SDRR values generally indicate greater heart rate variability, which is associated with good cardiovascular health and resilience to stress.
Measured: Baseline, 6 weeks, 8 weeks
Time-Domain Index of HRV：pNN50
Percentage of successive RR intervals that differ by more than 50 ms. pNN50 reflects beat-to-beat variance in heart rate and is considered an indicator of parasympathetic nervous system activity, specifically linked to vagal tone. A higher pNN50 typically indicates better heart rate variability and healthier autonomic function.
Measured: Baseline, 6 weeks, 8 weeks
Time-Domain Index of HRV：Root mean square of successive RR interval differences (RMSSD)
RMSSD is the square root of the mean of the squares of successive differences between adjacent RR intervals. It emphasizes the high-frequency variations in heart rate that are typically mediated by the parasympathetic nervous system
Measured: Baseline, 6 weeks, 8 weeks
Frequency-Domain Index of HRV: Low Frequency (LF)
The LF component typically represents the power of the HRV spectrum in the frequency range of 0.04 to 0.15 Hz. It is measured in milliseconds squared (ms²) or normalized units and is often interpreted as reflecting both sympathetic and parasympathetic activity,
Measured: Baseline, 6 weeks, 8 weeks
Frequency-Domain Index of HRV: High Frequency (HF)
HF typically covers the frequency range from 0.15 to 0.40 Hz and is associated with the respiratory cycle. HF power is usually measured in milliseconds squared (ms²) or normalized units and is indicative of the modulation of heart rate by the parasympathetic nervous system during breathing.
Measured: Baseline, 6 weeks, 8 weeks
Frequency-Domain Index of HRV: Ratio of LF to HF Power
The ratio of LF (low frequency) to HF power in the HRV spectrum. Since LF can represent both sympathetic and parasympathetic activity, comparing it to HF offers insights into the sympathetic-parasympathetic balance
Measured: Baseline, 6 weeks, 8 weeks
Total Time to Complete the Time Up and Go test
The time, in seconds, it takes for a participant to complete the TUG test from the initial sitting position to returning to the seated position.
Measured: Baseline, 6 weeks, 8 weeks
Secondary outcomes (15)
Double Support Time
The portion of the gait cycle where both feet are in contact with the ground, indicating the transition phase between steps, expressed as a percentage of the gait cycle or in seconds.
Measured: Baseline, 6 weeks, 8 weeks
Single Support Time
The duration within the gait cycle when only one foot is in contact with the ground, typically measured in seconds or as a percentage of the total gait cycle
Measured: Baseline, 6 weeks, 8 weeks
Swing Time
The portion of the gait cycle where the foot is not in contact with the ground, moving forward to the next step. It is usually expressed as a percentage of the total gait cycle or in seconds.
Measured: Baseline, 6 weeks, 8 weeks
Stance Time
The portion of the gait cycle when the foot is in contact with the ground, supporting body weight. It's typically expressed as a percentage of the total gait cycle or in seconds
Measured: Baseline, 6 weeks, 8 weeks
Cadence
The number of steps an individual takes per minute, providing an overview of gait speed and rhythm, expressed as steps per minute.
Measured: Baseline, 6 weeks, 8 weeks
Total UPDRS-III Score
The Unified Parkinson's Disease Rating Scale (UPDRS) Part III, also known as the UPDRS-III or the Motor Examination, is a critical component of the UPDRS used to assess the motor symptoms of Parkinson's disease (PD). To provide a comprehensive assessment of motor function in individuals with Parkinson's disease, covering aspects such as bradykinesia (slowness of movement), rigidity, tremors, and postural instability. The UPDRS-III consists of 14 items, each rated on a scale from 0 (normal) to 4 (severe), with a total possible score range from 0 to 108. Higher scores indicate greater motor impairment.
Measured: Baseline, 6 weeks, 8 weeks
Total NFOG-Q Score
The New Freezing of Gait Questionnaire (NFOG-Q) is a specialized tool designed to quantify the severity and impact of freezing of gait (FOG) episodes in individuals with Parkinson's disease (PD). To assess the presence, severity, and impact of FOG in individuals with Parkinson's disease, focusing on how it affects daily activities and mobility. The scores from Parts 2 and 3 are used to calculate a total score that reflects the overall severity and impact of FOG. This total score can help in gauging the effectiveness of treatments aimed at reducing the severity or frequency of FOG episodes.
Measured: Baseline, 6 weeks, 8 weeks
Overall PDQ-39 Score
To evaluate the quality of life across multiple dimensions affected by Parkinson's disease, including mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. The PDQ-39 consists of 39 items, with each item relating to an aspect of life potentially impacted by PD. Responses to these items are aggregated into eight scales corresponding to the dimensions mentioned above.Each item is scored on a scale from 0 (never) to 4 (always), with the total score for each dimension being converted to a 0-100 scale. A higher score indicates a lower quality of life.
Measured: Baseline, 6 weeks, 8 weeks
Total HADS Score
The Hospital Anxiety and Depression Scale (HADS) is a validated instrument designed to identify and quantify the severity of anxiety and depression symptoms, particularly focusing on the psychological rather than the somatic aspects to avoid confounding with physical illnesses. To screen for, and evaluate the severity of, anxiety and depression symptoms in a wide range of healthcare settings, especially useful in populations where physical illness might overlap with psychological distress. The scores for each subscale (anxiety and depression) range from 0 to 21. These can be combined to give a total HADS score, which ranges from 0 to 42, with higher scores indicating more severe symptoms.
Measured: Baseline, 6 weeks, 8 weeks
Overall PSQI Score
The Pittsburgh Sleep Quality Index (PSQI) is a comprehensive self-rated questionnaire that assesses sleep quality and disturbances over the past month. To evaluate the quality and patterns of sleep, identifying sleep disorders and quantifying the degree of sleep-related problems. Each component is scored on a scale of 0 to 3, with the total PSQI score ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Measured: Baseline, 6 weeks, 8 weeks
Non-linear Index of HRV: SD1
SD1 is calculated from the Poincaré plot, where it measures the dispersion of points perpendicular to the line of identity, usually expressed in milliseconds. This dispersion specifically quantifies the short-term variability in heart rate, primarily influenced by the parasympathetic nervous system. SD1 provides insight into the rapid changes in heart rate variability, offering a unique perspective on autonomic nervous system activity that traditional time-domain and frequency-domain measures might not fully capture.
Measured: Baseline, 6 weeks, 8 weeks
Non-linear Index of HRV: SD2
SD2 is calculated as the standard deviation of points along the line of identity in the Poincaré plot, reflecting long-term heart rate variability, usually expressed in milliseconds. This measure captures broader fluctuations in heart rate that are influenced by both sympathetic and parasympathetic nervous system activities. SD2 provides insights into the overall autonomic balance and the body's ability to adapt to sustained physiological stressors or environmental changes. It is particularly useful in studies investigating chronic stress, cardiovascular health, or the impact of long-term interventions.
Measured: Baseline, 6 weeks, 8 weeks
Non-linear Index of HRV: Ratio of SD1-to-SD2
The SD1/SD2 ratio is calculated by dividing SD1, which measures short-term variability and is predominantly influenced by parasympathetic activity, by SD2, which measures long-term variability and reflects both sympathetic and parasympathetic influences. This ratio is useful for assessing the autonomic balance or the sympathetic-parasympathetic interaction. A higher SD1/SD2 ratio indicates a dominance of parasympathetic activity relative to sympathetic, suggesting a more "relaxed" autonomic state, whereas a lower ratio indicates a relative dominance of sympathetic activity, which could be associated with stress, reduced cardiac health, or other health risks.
Measured: Baseline, 6 weeks, 8 weeks
Total Montreal Cognitive Assessment (MoCA) Score
The MoCA is a widely used cognitive screening tool that assesses multiple cognitive domains, including attention, memory, executive functions, language, visuospatial abilities, and orientation
Measured: Baseline, 6 weeks, 8 weeks
Total Mini-Mental State Examination (MMSE) Score
The MMSE is a widely used cognitive screening tool designed to assess global cognitive function across several domains, including orientation, registration, attention, calculation, recall, and language
Measured: Baseline, 6 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Oct 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD - Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598878
- Sponsor's protocol ID
- PD_001
- Status last verified
- Oct 2024
- First submitted
- 12 Sep 2024
- Last updated
- 8 Oct 2024
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of AR Environment Stimulation on Proactive and Reactive Modulation of Gait in Individuals With Parkinson Disease
- ClinicalTrials.gov ID
- NCT06598878
- Acronym / sponsor ID
- PD_001
- Conditions
- PD - Parkinson's Disease
- Keywords
- Augmented Reality, Gait Taining, Heart Rate Variability (HRV)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Gait disorders in Parkinson's disease (PD), particularly in complex environments or under stress, present challenges for accurate evaluation and classification, such as in cases of freezing of gait. Traditional clinical and laboratory settings often fail to replicate the complexity needed for precise classification, making effective rehabilitation difficult. This study aims to address these challenges by developing an augmented reality (AR)-based environment that mimics real-world stressors and dynamically adapts to the patient's condition. The AR system is designed to facilitate individualized gait training and rehabilitation by modifying environmental difficulty based on real-time feedback from gait performance and stress levels.
Building on Gentile's taxonomy of tasks, the investigators have incorporated PD-specific factors, such as cognitive dual tasks, into our environment classification system. Preliminary results suggest that this system effectively elicits varying gait and heart rate variability (HRV) responses, indicating different stress levels.
This trial will further test the AR environment's ability to classify patients based on their responses to complex, interactive environments, while also investigating the effects of adaptive AR-based gait training on both gait and stress management in individuals with PD.
Detailed description
Gait disorder in Parkinson's disease (PD), has been reported to be related to complex environments and stress situations. To perform precise evaluation on gait disorder, such as freezing of gait, is not easy in clinical and/or lab environment, causing the difficulty to make accurate classification of gait disorder. Designing a standard environment stimulation paradigm helps to promote precise classification of gait disorders. Monitoring the stress situation that causes gait disorder, and dynamically modifying environment assists in the facilitation of effective individualized gait rehabilitation for PD patients.
Although Gentile's taxonomy of tasks provides a structure to examine the complexity of movement task in accordance with environmental context, this taxonomy and environmental context does not specifically reflects PD movement problems. In this on-going project, the investigators developed an environment classification system based on Gentile's taxonomy, but added PD related factors, such as cognitive dual task to meet the needs of this population. Our preliminary results showed that this novel classification successfully induced different levels of gait and HRV responses, suggesting different stress situations.
For the following, the investigators plan to apply the Augment reality (AR) technique to produce standard interactive testing and training environment. AR allows us to mimic complex environments in lab for evaluation and rehabilitation. In addition, AR could interactively change the difficulty of environment according to the patients'gait and stress situation which is important for developing effective personal rehabilitation program
The purposes for this project are as follows:
- Test the AR environment stimulation on classifying patients and establish the relationships among challenging AR environment, pressure, and gait
- Investigate the effects of interactive AR gait training on gait and stress for individuals with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD patients | Experimental | Procedure: AR gait trainingAR gait training |
| PD patients (Control) | No intervention | –Control Group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Parkinson disease.
Key exclusion criteria (3 listed)
- Musculoskeletal injuries on legs
- Osteoporosis.
- Any peripheral or central nervous system injury or disease patients.
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 |
|---|---|---|
| AR gait trainingParticipants will walk on a pathway projected in augmented reality (AR), following the instructions provided on the pathway Each session will last for 60 minutes, conducted three times per week, over a period of six weeks. | Procedure or surgery | PD patients |
Primary outcome
Walking Speed
Time frame: Baseline, 6 weeks, 8 weeks
The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Step Length
Time frame: Baseline, 6 weeks, 8 weeks
The linear distance between the two ankles, typically expressed in centimeter(cm).
Step Time
Time frame: Baseline, 6 weeks, 8 weeks
The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.
Time-Domain Index of Heart Rate Variability (HRV)：Standard deviation of RR intervals (SDRR)
Time frame: Baseline, 6 weeks, 8 weeks
SDRR is the standard deviation of all recorded RR intervals (the time between successive heartbeats) over a specific period, usually expressed in milliseconds. This measure captures the total variability in heart rate, representing the physiological responses to a variety of internal and external stimuli. High SDRR values generally indicate greater heart rate variability, which is associated with good cardiovascular health and resilience to stress.
Time-Domain Index of HRV：pNN50
Time frame: Baseline, 6 weeks, 8 weeks
Percentage of successive RR intervals that differ by more than 50 ms. pNN50 reflects beat-to-beat variance in heart rate and is considered an indicator of parasympathetic nervous system activity, specifically linked to vagal tone. A higher pNN50 typically indicates better heart rate variability and healthier autonomic function.
Time-Domain Index of HRV：Root mean square of successive RR interval differences (RMSSD)
Time frame: Baseline, 6 weeks, 8 weeks
RMSSD is the square root of the mean of the squares of successive differences between adjacent RR intervals. It emphasizes the high-frequency variations in heart rate that are typically mediated by the parasympathetic nervous system
Frequency-Domain Index of HRV: Low Frequency (LF)
Time frame: Baseline, 6 weeks, 8 weeks
The LF component typically represents the power of the HRV spectrum in the frequency range of 0.04 to 0.15 Hz. It is measured in milliseconds squared (ms²) or normalized units and is often interpreted as reflecting both sympathetic and parasympathetic activity,
Frequency-Domain Index of HRV: High Frequency (HF)
Time frame: Baseline, 6 weeks, 8 weeks
HF typically covers the frequency range from 0.15 to 0.40 Hz and is associated with the respiratory cycle. HF power is usually measured in milliseconds squared (ms²) or normalized units and is indicative of the modulation of heart rate by the parasympathetic nervous system during breathing.
Frequency-Domain Index of HRV: Ratio of LF to HF Power
Time frame: Baseline, 6 weeks, 8 weeks
The ratio of LF (low frequency) to HF power in the HRV spectrum. Since LF can represent both sympathetic and parasympathetic activity, comparing it to HF offers insights into the sympathetic-parasympathetic balance
Total Time to Complete the Time Up and Go test
Time frame: Baseline, 6 weeks, 8 weeks
The time, in seconds, it takes for a participant to complete the TUG test from the initial sitting position to returning to the seated position.
15 secondary outcomes
Double Support Time
Time frame: Baseline, 6 weeks, 8 weeks
Single Support Time
Time frame: Baseline, 6 weeks, 8 weeks
Swing Time
Time frame: Baseline, 6 weeks, 8 weeks
Stance Time
Time frame: Baseline, 6 weeks, 8 weeks
Cadence
Time frame: Baseline, 6 weeks, 8 weeks
Total UPDRS-III Score
Time frame: Baseline, 6 weeks, 8 weeks
Total NFOG-Q Score
Time frame: Baseline, 6 weeks, 8 weeks
Overall PDQ-39 Score
Time frame: Baseline, 6 weeks, 8 weeks
Total HADS Score
Time frame: Baseline, 6 weeks, 8 weeks
Overall PSQI Score
Time frame: Baseline, 6 weeks, 8 weeks
Non-linear Index of HRV: SD1
Time frame: Baseline, 6 weeks, 8 weeks
Non-linear Index of HRV: SD2
Time frame: Baseline, 6 weeks, 8 weeks
Non-linear Index of HRV: Ratio of SD1-to-SD2
Time frame: Baseline, 6 weeks, 8 weeks
Total Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline, 6 weeks, 8 weeks
Total Mini-Mental State Examination (MMSE) Score
Time frame: Baseline, 6 weeks, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR gait training in people with PD - Parkinson's Disease, run by Chang Gung University at 1 site in Taiwan.
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 1 inclusion and 3 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 8 Oct 2024. 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed (time frame: Baseline, 6 weeks, 8 weeks). The study lists 10 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 8 Oct 2024.