Parkinson DiseaseNCT04339543
Longitudinal Analysis of Gait Variability to Predict Falls in Parkinson's Disease
A study testing Cognitive dual-task walking in people with Parkinson Disease and Healthy Aging, run by University of Nebraska at 1 site in United States.
Trial summary
The broad goal of this research project is to improve the prediction of falls in patients with Parkinson's disease (PD) through a comprehensive multidisciplinary approach that includes longitudinal measurements of walking, cognitive and functional performances. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Healthy Aging
- What is being tested?
- Cognitive dual-task walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2020to 15 Feb 2022
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent
- 60 years or older
- Able to walk 10 min uninterrupted without assistance
- for PD group only: must have a confirmed diagnosis by a trained clinician of idiopathic PD
Who cannot join
- other known neurological, orthopedic or cardiothoracic conditions that could interfere with gait and cognitive assessment.
- surgery affecting gait and balance within 6 months prior to baseline session.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska at Omaha
Omaha, Nebraska, 68182
About this study
Official title: Longitudinal Assessment of Gait Variability to Predict Falls in Parkinson's Disease
The broad goal of this research project is to improve the prediction of falls in patients with Parkinson's disease (PD) through a comprehensive multidisciplinary approach that includes longitudinal measurements of walking, cognitive and functional performances. PD is a life-changing disorders affecting one million Americans, with more than 60,000 new cases reported every year. Within 3 years of diagnosis, more than 85% of people with clinically probable PD develop gait problems, which in turn lead to falls resulting in serious injury and reduced quality of life. There is a pressing need to identify fall risk factors before the occurrence of the first fall, and to better understand behavioral and cognitive changes leading to falls in PD patients.
Read the detailed description
Participants will take part in a baseline study session, followed by a year of weekly reports of their number of near falls and falls. The same participants will repeat the same study session six months and twelve months after the baseline session.
Each of the three study sessions will have a similar design. Each participant will make a visit of approximately 2 hours to the laboratory. At baseline, all participants will complete a medical history questionnaire which will confirm that all inclusion criteria are met. At each measurement interval (i.e., baseline, six-month and twelve-month), participants will be evaluated through a series of examinations and questionnaires prior to data collection. PD patients will be tested at their self-reported peak dose of medication ('on'-state). Upon completion of the tests and questionnaires, participants will be prepared for data collection (footswitches and strap-based IMUs).
The effect of dual tasking will be examined through three conditions performed in the following order: single-cognitive testing, which will consist in a phoneme monitoring task (seated in a quiet room with headphones); single-walking, which will consist of simply walking normally (silent headphones); and dual-task walking, which will consist in walking while performing the phoneme monitoring task. The phoneme monitoring task will consist in listening to a text through headphones, and participants will be asked to i) answer ten questions regarding the content of the text after the task, and ii) count how many times two predefined words appeared in the text. During single and dual-task walking, participants will be asked to walk around the track at a speed that they feel would be comfortable while walking through the grocery store or walking to their car, with no instructions regarding the priority to give to each task (walking vs. cognitive task). The texts presented during single-task cognitive testing and dual-task walking will be different.
Each trial will last approximately ten minutes, which is required to collect at least 500 stride time intervals for a reliable estimation of the temporal ordering of stride-to-stride fluctuations. Participants will rest between trials for at least five minutes and will be able to rest more if they so desire. Two investigators will always be present during data collection and will walk behind the participant during the walking trials for safety purposes.
All participants will be followed for twelve months and will report their falls and near falls experiences. After the baseline session, participants will be provided with a fall diary, in which they will write the date, time, cause, circumstances under which falls or near falls occurred, and the occurrence of any fall-related injury. Participants will be instructed to daily fill the diary and return it every two weeks (with self-addressed stamped return envelope), or to communicate the information via email. In addition, each month participating personnel will call participants to ensure all falls and near falls were reported in case participants fail to fill in the fall diary. Participants will also be called if the investigators do not receive their report a week after the expected date of reception.
- Conditions
- Parkinson Disease, Healthy Aging
- Being tested
- Cognitive dual-task walking
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive dual-task walkingOther
- The task will consist in walking while performing the phoneme monitoring task. The phoneme monitoring task will consist in listening to a text through headphones, and participants will be asked to i) answer ten questions regarding the content of the text after the task, and ii) count how many times two predefined words appeared in the text. During single and dual-task walking, participants will be asked to walk around the track at a speed that they feel would be comfortable while walking through the grocery store or walking to their car, with no instructions regarding the priority to give to each task (walking vs. cognitive task).
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal assessment | Other | Participants will take part in a baseline study session, followed by a year of weekly reports of their number of near falls and falls. The same participants will repeat the same study session six months and twelve months after the baseline session. Receives: Other: Cognitive dual-task walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scaling exponent of stride time series every 6-months
Using the detrended fluctuation analysis (DFA). Briefly, DFA estimate the relationship between the size of fluctuations and the size of the 'box' from which these fluctuations are observed. Stride time fluctuations typically scale with the size of the box in a power-law relationship. The slope of this relationship in bi-logarithmic coordinate thus provide the scaling exponent which reflect the degree of scale invariance.
Measured: Baseline, 6-month follow-up, 12-months follow-up
Falls and near falls
Number and type of falls and near falls experienced, reported in a diary.
Measured: 12-months
Secondary outcomes (1)
Change in gait biomechanics every 6-months
Sub-phases of stride cycles, in particular the stance phase (i.e., when the foot is in contact with the ground) and the swing phase (i.e., when the foot is in the air), which will provide information about balance control mechanisms; medial-lateral center of mass movements and local stability, estimated with the Lyapunov exponent, using data from the pelvis sensor, which will provide information about gait stability; coordination between arm and leg movements, which will inform about the degree of rigidity and central synchronization between the arms during walking.
Measured: Baseline, 6-month follow-up, 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start28 Feb 2020
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Why it stopped: PI left the institution and the US
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Nicholas Stergiou, PhD, Study director, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339543
- Sponsor's protocol ID
- 0596-18-EP
- Other IDs
- P20GM109090-06
- Status last verified
- Aug 2024
- First submitted
- 3 Apr 2020
- Last updated
- 5 Sep 2024
- 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 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Gait Variability to Predict Falls in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04339543
- Acronym / sponsor ID
- 0596-18-EP
- Conditions
- Parkinson Disease, Healthy Aging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution and the US
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 9 Apr 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 broad goal of this research project is to improve the prediction of falls in patients with Parkinson's disease (PD) through a comprehensive multidisciplinary approach that includes longitudinal measurements of walking, cognitive and functional performances. PD is a life-changing disorders affecting one million Americans, with more than 60,000 new cases reported every year. Within 3 years of diagnosis, more than 85% of people with clinically probable PD develop gait problems, which in turn lead to falls resulting in serious injury and reduced quality of life. There is a pressing need to identify fall risk factors before the occurrence of the first fall, and to better understand behavioral and cognitive changes leading to falls in PD patients.
Detailed description
Participants will take part in a baseline study session, followed by a year of weekly reports of their number of near falls and falls. The same participants will repeat the same study session six months and twelve months after the baseline session.
Each of the three study sessions will have a similar design. Each participant will make a visit of approximately 2 hours to the laboratory. At baseline, all participants will complete a medical history questionnaire which will confirm that all inclusion criteria are met. At each measurement interval (i.e., baseline, six-month and twelve-month), participants will be evaluated through a series of examinations and questionnaires prior to data collection. PD patients will be tested at their self-reported peak dose of medication ('on'-state). Upon completion of the tests and questionnaires, participants will be prepared for data collection (footswitches and strap-based IMUs).
The effect of dual tasking will be examined through three conditions performed in the following order: single-cognitive testing, which will consist in a phoneme monitoring task (seated in a quiet room with headphones); single-walking, which will consist of simply walking normally (silent headphones); and dual-task walking, which will consist in walking while performing the phoneme monitoring task. The phoneme monitoring task will consist in listening to a text through headphones, and participants will be asked to i) answer ten questions regarding the content of the text after the task, and ii) count how many times two predefined words appeared in the text. During single and dual-task walking, participants will be asked to walk around the track at a speed that they feel would be comfortable while walking through the grocery store or walking to their car, with no instructions regarding the priority to give to each task (walking vs. cognitive task). The texts presented during single-task cognitive testing and dual-task walking will be different.
Each trial will last approximately ten minutes, which is required to collect at least 500 stride time intervals for a reliable estimation of the temporal ordering of stride-to-stride fluctuations. Participants will rest between trials for at least five minutes and will be able to rest more if they so desire. Two investigators will always be present during data collection and will walk behind the participant during the walking trials for safety purposes.
All participants will be followed for twelve months and will report their falls and near falls experiences. After the baseline session, participants will be provided with a fall diary, in which they will write the date, time, cause, circumstances under which falls or near falls occurred, and the occurrence of any fall-related injury. Participants will be instructed to daily fill the diary and return it every two weeks (with self-addressed stamped return envelope), or to communicate the information via email. In addition, each month participating personnel will call participants to ensure all falls and near falls were reported in case participants fail to fill in the fall diary. Participants will also be called if the investigators do not receive their report a week after the expected date of reception.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal assessment | Other | Other: Cognitive dual-task walkingParticipants will take part in a baseline study session, followed by a year of weekly reports of their number of near falls and falls. The same participants will repeat the same study session six months and twelve months after the baseline session. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide written informed consent
- 60 years or older
- Able to walk 10 min uninterrupted without assistance
- for PD group only: must have a confirmed diagnosis by a trained clinician of idiopathic PD
Key exclusion criteria (2 listed)
- other known neurological, orthopedic or cardiothoracic conditions that could interfere with gait and cognitive assessment.
- surgery affecting gait and balance within 6 months prior to baseline session.
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 |
|---|---|---|
| Cognitive dual-task walking• The task will consist in walking while performing the phoneme monitoring task. The phoneme monitoring task will consist in listening to a text through headphones, and participants will be asked to i) answer ten questions regarding the content of the text after the task, and ii) count how many times two predefined words appeared in the text. During single and dual-task walking, participants will be asked to walk around the track at a speed that they feel would be comfortable while walking through the grocery store or walking to their car, with no instructions regarding the priority to give to each task (walking vs. cognitive task). | Other | Longitudinal assessment |
Primary outcome
Change in scaling exponent of stride time series every 6-months
Time frame: Baseline, 6-month follow-up, 12-months follow-up
Using the detrended fluctuation analysis (DFA). Briefly, DFA estimate the relationship between the size of fluctuations and the size of the 'box' from which these fluctuations are observed. Stride time fluctuations typically scale with the size of the box in a power-law relationship. The slope of this relationship in bi-logarithmic coordinate thus provide the scaling exponent which reflect the degree of scale invariance.
Falls and near falls
Time frame: 12-months
Number and type of falls and near falls experienced, reported in a diary.
1 secondary outcome
Change in gait biomechanics every 6-months
Time frame: Baseline, 6-month follow-up, 12-months follow-up
Results and safety
The study was stopped early (reason given: PI left the institution and the US). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- 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.
Nicholas Stergiou, PhD study director
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive dual-task walking in people with Parkinson Disease and Healthy Aging, run by University of Nebraska 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 5 Sep 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 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 was stopped early (reason given: PI left the institution and the US). Results are not available in the source record.
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?
Change in scaling exponent of stride time series every 6-months (time frame: Baseline, 6-month follow-up, 12-months follow-up). 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?
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 5 Sep 2024.