Parkinson DiseaseNCT04674319
Attending to External Cues and Movement Strategies in Parkinson Disease
A study testing external cues and cogntive movement strategies in people with Parkinson Disease, run by Galit Yogev-Seligmann at 1 site in Israel.
Trial summary
People with Parkinson's disease use compensatory strategies to overcome typical gait disturbances. These strategies rely on attentional mechanisms, however people with Parkinson disease suffer of decline in cognitive function. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- external cues and cogntive movement strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2019to 30 Aug 2021
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease
- Age of 50-85
- Able to walk independently in daily lives.
- Age of 50-85
- Able to walk independently in daily lives.
Who cannot join
- Use of assistive hearing device
- Suffer of hearing impairment (by self-declaration)
- Suffer of dementia (MoCa test score above 21)
- Suffer of any orthopedic condition
- Pains or other health condition that may affect gait except of PD
- Use of assistive hearing device
Show all 10Show fewer
- Suffer of hearing impairment (by self-declaration)
- Suffer of dementia (MoCa test score above 21)
- Suffer of any orthopedic condition
- Pains or other health condition that may affect gait
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attending to External Cues and Movement Strategies in Parkinson Disease: Feasibility in Ecological Setting.
People with Parkinson's disease use compensatory strategies to overcome typical gait disturbances. These strategies rely on attentional mechanisms, however people with Parkinson disease suffer of decline in cognitive function. Therefore, the current study aims at exploring brain engagement and focus of attention process during walking with these compensatory strategies, in people with Parkinson disease. Such exploration would assist in understanding the feasibility of the compensatory strategies in daily lives of people with Parkinson's disease.
Read the detailed description
External cues and cognitive movement strategies are common compensatory modes that people with Parkinson's disease can use to overcome typical gait disturbances. It is suggested that these modes utilize alternative neural pathways, bypassing the impaired basal ganglia motor circuits in the brain. In addition, both compensatory modes, in particular the movement cognitive strategies, are suggested to rely on attentional mechanisms.
Cognitive deficits are common in PwP and include among others, impairment of attention, particularly in tasks requiring internal control of attention. Considering that gait compensatory modes may rely on cognitive function, in particular the cognitive movement strategies, it is not clear whether People with Parkinson's disease can engaged with these strategies for a prolonged time or distance as in many cases required in daily living.
Therefore, the objectives of this study are 1) to test the effect of compensatory modes- external cueing and cognitive movement strategy on gait in prolonged walking. 2) to test whether people with Parkinson's disease can stay engaged and focus their attention to these compensatory modes for prolonged time. 3) to test whether subject's cognitive function is related to the ability to stay engaged with these compensatory modes. Subjects are recruited from a community physical- therapy groups for people with Parkinson's disease. Healthy older adults will be recruited from the community and will serve as a control group. Participants are invited for two separate evaluation sessions that includes: 1. Assessment of background characteristic: demographic details, severity of disease ( assessed by the Unified Parkinson's Disease Rating Scale-UPDRS), Levodopa Equivalent Dose (LED), freezing of gait questionnaire (FOG-Q) and Montreal cognitive assessment (MoCA).
- Evaluation of gait while attending to external cues and cognitive movement strategy.
- Evaluation of brain engagement during gait 4. Computerized cognitive assessment
- Conditions
- Parkinson Disease
- Being tested
- external cues and cogntive movement strategies
- Keywords
- Parkinson's disease, Gait, Attention, External cues
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external cues and cogntive movement strategiesBehavioural
external cueing are sensory stimuli such as auditory (e.g. rhythmic metronome beats) or or visual (e.g. spaced lines on the floor). Cognitive movement strategies refer to focusing attention on a specific parameter of gait (e.g. step length, arm swing).
In the study participants walk under four walking conditions:1)usuall (baseline) walking 2)walking while attending to external cues wich will be applied via metronome beats. The number of beats per minute is adjusted to each participant's steps number per minute. 3)walking with movement cognitive strategy: participants are requested to focus on their step length- and focus on increasing their step length while walking 4) Dual tasking-walking while performing a cognitive task.
During the four walking conditions Brain engegament will be measured, using the single-channel EEG system (Brain-MARC LTD) described in the follwing outcomes measures section.
| Study group | Role | What they receive |
|---|---|---|
| Brain engagement while using compesatory modes for walking | Experimental | Brain engagemnent (recruitment of attention) is measured during four walking conditions Receives: Behavioral: external cues and cogntive movement strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed- Physiological measurement of gait
Gait speed is measured with the Mobility Lab OPAL system (APDM, USA) consisting of three small inertial measurement units (IMU sensors including 3D accelerometers and 3D gyroscopes sampled at 128 Hz, MobilityLab, APDM Inc., Portland, OR). IMUs were attached at the participant's ankles, and lumbar region using elastic Velcro straps. These sensors are measuring gait speed (meters per second).
Measured: Through study completion, an average of 1 year
Step length- Physiological measurement of gait
Step length is measured with the Mobility Lab OPAL system (APDM, USA) consisting of three small inertial measurement units (IMU sensors including 3D accelerometers and 3D gyroscopes sampled at 128 Hz, MobilityLab, APDM Inc., Portland, OR). IMUs were attached at the participant's ankles, and lumbar region using elastic Velcro straps. These sensors are measuring step length (cm).
Measured: Through study completion, an average of 1 year
Cadence- Physiological measurement of gait
Cadence is measured with the Mobility Lab OPAL system (APDM, USA) consisting of three small inertial measurement units (IMU sensors including 3D accelerometers and 3D gyroscopes sampled at 128 Hz, MobilityLab, APDM Inc., Portland, OR). IMUs were attached at the participant's ankles, and lumbar region using elastic Velcro straps.These sensors are measuring cadence (number of steps taken in 1 minute).
Measured: Through study completion, an average of 1 year
Swing time percent- Physiological measurement of gait
Swing time percent (the percent of time from the total time of one gait cycle that one leg is in the air is measured with the Mobility Lab OPAL system (APDM, USA) consisting of three small inertial measurement units (IMU sensors including 3D accelerometers and 3D gyroscopes sampled at 128 Hz, MobilityLab, APDM Inc., Portland, OR). IMUs were attached at the participant's ankles, and lumbar region using elastic Velcro straps.These sensors are measuring swing time percent (unit are given in percents)
Measured: Through study completion, an average of 1 year
Electrical activity (eeg) of the brain-phisyological measure of electircal signals
During the walking, measure of attention recruitment during walking is applied by a single-channel EEG system (Brain-MARC LTD). The system simplifies EEG analysis to adjust the extraction of relevant attention-related markers from ongoing EEG. EEG is sampled using the MindWave dry electrode system [25], with one frontal electrode (∼Fpz) and one reference electrode on the earlobe. The sampled data are transferred through a wireless connection to the experiment computer, where the signal is processed. An algorithm is calaculating
Measured: Through study completion, an average of 1 year
Secondary outcomes (10)
Cognitive function Go-NoGo Response Inhibition
NeuroTrax™ computerized tests assess brain wellness across an array of cognitive domains. Specifically, the Go-NoGo Response Inhibition tests abilities of Attention and Executive Function.
The Go-NoGo test is a test of response time and response inhibition. Participants are presented with a series of large colored squares at variable delays. Each square may be one of four colors. Participants are instructed to respond as quickly as possible by pressing a mouse button if the square is any color but red. Outcome parameters include accuracy (i.e., percent correct), response time and its associated variance, a composite score computed as accuracy divided by response time, number of errors of omission, number of errors of commission, and response time associated with errors of commission.
Measured: Through study completion, an average of 1 year
Cognitive function-Stroop Interference
NeuroTrax™ computerized tests assess brain wellness across an array of cognitive domains. Specifically, Stroop Interference tests abilities of Attention, Executive Function.
The Stroop test measures response time and executive function. In the test subjects are required to say the color of the word on the screen, not what the word says. Outcome parameters include accuracy, response time and its associated variance, and a composite score computed as accuracy divided by response time.
Measured: Through study completion, an average of 1 year
Cognitive function-Staged Information Processing Speed
NeuroTrax™ computerized tests assess brain wellness across an array of cognitive domains. Specifically, Staged Information Processing Speed test abilities of Attention and Information Processing Speed. The Staged Information Processing Speed test measures information processing at increasing levels of complexity. The test is comprised of three levels of information processing load: single digits, two-digit arithmetic problems (e.g., 5-1), and three-digit arithmetic problems (e.g., 3+2-1). Participants are presented with a series of digits or arithmetic problems (as per the level) and are instructed to respond as quickly as possible by pressing the left mouse button if the digit or result is less than or equal to 4 and the right mouse button if it is greater than 4. Outcome parameters for each rate increment for each level include accuracy, response time and its
Measured: Through study completion, an average of 1 year
Cognitive function-Finger Tapping
NeuroTrax™ computerized tests assess brain wellness across an array of cognitive domains. Specifically, Finger Tapping tests motor skills. Participants are presented with a white rectangle, which fills with red from left to right over 12 sec. The task requires the participant to tap the left mouse button as many times as possible while the rectangle fills with red. The outcome parameters for this test include inter-tap interval and associated variance (in milliseconds) for the participant's dominant hand.
Measured: Through study completion, an average of 1 year
Cognitive function-'Catch' Game
NeuroTrax™ computerized tests assess brain wellness across an array of cognitive domains. Specifically, the 'Catch' Game tests abilities of Executive Function and Motor Skills. During the 'Catch' Game participants see a rectangular white object falling vertically from the top of the screen. Their task is to "catch" the object before it reaches the bottom of the screen by positioning the rectangular green paddle directly in the path of the falling object. Responses are made with the participant's best hand. The rate of the falling object increases incrementally as the test continues making it increasingly difficult to "catch" the object in time. Outcome parameters include response time and associated variance for the first move, number of direction changes per trial, error for missed catches, and a total performance score.
Measured: Through study completion, an average of 1 year
Cognitive function-Problem Solving
NeuroTrax™ computerized tests assess brain wellness across an array of cognitive domains. Specifically,the NeuroTrax Problem Solving test is a non-verbal IQ test that assesses the ability to appreciate the spatial relationships among geometric forms that constitute a pattern. Participants are presented with an incomplete pattern consisting of three squares containing simple geometric forms in a particular configuration. Six additional squares containing geometric forms are presented along the bottom of the screen. Responses with the keyboard number pad indicate which of the six forms best completes the pattern. The spatial relationships among the simple geometric forms become more complex as the test progresses, and the test is adaptive in that it terminates early when performance is poor. The outcome parameter for this test consists of a total accuracy score that incorporates performance at differing levels of difficulty.
Measured: Through study completion, an average of 1 year
Cognitive function-executive function index score
Groups of normalized parameters that measure executive function are averaged to produce index score of executive function. The Outcome Parameters Comprising this Index Scores are: Go-NoGo: Composite Score; Stroop Interference: Composite Score; Catch Game: Total Score.
Measured: Through study completion, an average of 1 year
Cognitive function-Attention index score
Groups of normalized parameters that measure attention are averaged to produce index score of attention. The Outcome Parameters Comprising this Index Scores are: Go-NoGo: Response Time; Go-NoGo: Response Time Standard Deviation; Stroop Interference: Response Time; Staged Info Processing: Response Time; Information Processing: Accuracy.
Measured: Through study completion, an average of 1 year
Cognitive function-Information Processing Speed index score
Groups of normalized parameters that measure Information Processing Speed are averaged to produce index score of Information Processing Speed. The Outcome Parameters Comprising this Index Scores are: Staged Information Processing: Composite Score, Level 1.1; Staged Information Processing: Composite Score, Level 1.3; Staged Information Processing: Composite Score, Level 2.1; Staged Information Processing: Composite Score, Level 2.2
Measured: Through study completion, an average of 1 year
Cognitive function-motor skills index score
Groups of normalized parameters that measure motor skills are averaged to produce index score of motor skills. The Outcome Parameters Comprising this Index Scores are: Finger Tapping: Inter-Tap Interval; Finger Tapping: Tap Interval Std Dev; Catch Game: Time to Make 1st Move
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Mar 2019
- Primary completion30 Aug 2020
- Study completion30 Aug 2021
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.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galit Yogev-Seligmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Galit Yogev-Seligmann, University of Haifa
- Investigators
- Galit Yogev-Seligmann, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674319
- Sponsor's protocol ID
- 052/19
- Status last verified
- Jan 2022
- First submitted
- 1 Sep 2020
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attending to External Cues and Movement Strategies in Parkinson Disease: Feasibility in Ecological Setting.
- ClinicalTrials.gov ID
- NCT04674319
- Acronym / sponsor ID
- 052/19
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Gait, Attention, External cues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Galit Yogev-SeligmannUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 19 Dec 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.
People with Parkinson's disease use compensatory strategies to overcome typical gait disturbances. These strategies rely on attentional mechanisms, however people with Parkinson disease suffer of decline in cognitive function. Therefore, the current study aims at exploring brain engagement and focus of attention process during walking with these compensatory strategies, in people with Parkinson disease. Such exploration would assist in understanding the feasibility of the compensatory strategies in daily lives of people with Parkinson's disease.
Detailed description
External cues and cognitive movement strategies are common compensatory modes that people with Parkinson's disease can use to overcome typical gait disturbances. It is suggested that these modes utilize alternative neural pathways, bypassing the impaired basal ganglia motor circuits in the brain. In addition, both compensatory modes, in particular the movement cognitive strategies, are suggested to rely on attentional mechanisms.
Cognitive deficits are common in PwP and include among others, impairment of attention, particularly in tasks requiring internal control of attention. Considering that gait compensatory modes may rely on cognitive function, in particular the cognitive movement strategies, it is not clear whether People with Parkinson's disease can engaged with these strategies for a prolonged time or distance as in many cases required in daily living.
Therefore, the objectives of this study are 1) to test the effect of compensatory modes- external cueing and cognitive movement strategy on gait in prolonged walking. 2) to test whether people with Parkinson's disease can stay engaged and focus their attention to these compensatory modes for prolonged time. 3) to test whether subject's cognitive function is related to the ability to stay engaged with these compensatory modes. Subjects are recruited from a community physical- therapy groups for people with Parkinson's disease. Healthy older adults will be recruited from the community and will serve as a control group. Participants are invited for two separate evaluation sessions that includes: 1. Assessment of background characteristic: demographic details, severity of disease ( assessed by the Unified Parkinson's Disease Rating Scale-UPDRS), Levodopa Equivalent Dose (LED), freezing of gait questionnaire (FOG-Q) and Montreal cognitive assessment (MoCA).
- Evaluation of gait while attending to external cues and cognitive movement strategy.
- Evaluation of brain engagement during gait 4. Computerized cognitive assessment
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain engagement while using compesatory modes for walking | Experimental | Behavioral: external cues and cogntive movement strategiesBrain engagemnent (recruitment of attention) is measured during four walking conditions |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Parkinson's disease
- Age of 50-85
- Able to walk independently in daily lives.
- Age of 50-85
- Able to walk independently in daily lives.
Key exclusion criteria (10 listed)
- Use of assistive hearing device
- Suffer of hearing impairment (by self-declaration)
- Suffer of dementia (MoCa test score above 21)
- Suffer of any orthopedic condition
- Pains or other health condition that may affect gait except of PD
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 |
|---|---|---|
| external cues and cogntive movement strategiesexternal cueing are sensory stimuli such as auditory (e.g. rhythmic metronome beats) or or visual (e.g. spaced lines on the floor). Cognitive movement strategies refer to focusing attention on a specific parameter of gait (e.g. step length, arm swing). In the study participants walk under four walking conditions:1)usuall (baseline) walking 2)walking while attending to external cues wich will be applied via metronome beats. The number of beats per minute is adjusted to each participant's steps number per minute. 3)walking with movement cognitive strategy: participants are requested to focus on their step length- and focus on increasing their step length while walking 4) Dual tasking-walking while performing a cognitive task. During the four walking conditions Brain engegament will be measured, using the single-channel EEG system (Brain-MARC LTD) described in the follwing outcomes measures section. | Behavioural | Brain engagement while using compesatory modes for walking |
Primary outcome
Gait speed- Physiological measurement of gait
Time frame: Through study completion, an average of 1 year
Gait speed is measured with the Mobility Lab OPAL system (APDM, USA) consisting of three small inertial measurement units (IMU sensors including 3D accelerometers and 3D gyroscopes sampled at 128 Hz, MobilityLab, APDM Inc., Portland, OR). IMUs were attached at the participant's ankles, and lumbar region using elastic Velcro straps. These sensors are measuring gait speed (meters per second).
Step length- Physiological measurement of gait
Time frame: Through study completion, an average of 1 year
Step length is measured with the Mobility Lab OPAL system (APDM, USA) consisting of three small inertial measurement units (IMU sensors including 3D accelerometers and 3D gyroscopes sampled at 128 Hz, MobilityLab, APDM Inc., Portland, OR). IMUs were attached at the participant's ankles, and lumbar region using elastic Velcro straps. These sensors are measuring step length (cm).
Cadence- Physiological measurement of gait
Time frame: Through study completion, an average of 1 year
Cadence is measured with the Mobility Lab OPAL system (APDM, USA) consisting of three small inertial measurement units (IMU sensors including 3D accelerometers and 3D gyroscopes sampled at 128 Hz, MobilityLab, APDM Inc., Portland, OR). IMUs were attached at the participant's ankles, and lumbar region using elastic Velcro straps.These sensors are measuring cadence (number of steps taken in 1 minute).
Swing time percent- Physiological measurement of gait
Time frame: Through study completion, an average of 1 year
Swing time percent (the percent of time from the total time of one gait cycle that one leg is in the air is measured with the Mobility Lab OPAL system (APDM, USA) consisting of three small inertial measurement units (IMU sensors including 3D accelerometers and 3D gyroscopes sampled at 128 Hz, MobilityLab, APDM Inc., Portland, OR). IMUs were attached at the participant's ankles, and lumbar region using elastic Velcro straps.These sensors are measuring swing time percent (unit are given in percents)
Electrical activity (eeg) of the brain-phisyological measure of electircal signals
Time frame: Through study completion, an average of 1 year
During the walking, measure of attention recruitment during walking is applied by a single-channel EEG system (Brain-MARC LTD). The system simplifies EEG analysis to adjust the extraction of relevant attention-related markers from ongoing EEG. EEG is sampled using the MindWave dry electrode system [25], with one frontal electrode (∼Fpz) and one reference electrode on the earlobe. The sampled data are transferred through a wireless connection to the experiment computer, where the signal is processed. An algorithm is calaculating
10 secondary outcomes
Cognitive function Go-NoGo Response Inhibition
Time frame: Through study completion, an average of 1 year
Cognitive function-Stroop Interference
Time frame: Through study completion, an average of 1 year
Cognitive function-Staged Information Processing Speed
Time frame: Through study completion, an average of 1 year
Cognitive function-Finger Tapping
Time frame: Through study completion, an average of 1 year
Cognitive function-'Catch' Game
Time frame: Through study completion, an average of 1 year
Cognitive function-Problem Solving
Time frame: Through study completion, an average of 1 year
Cognitive function-executive function index score
Time frame: Through study completion, an average of 1 year
Cognitive function-Attention index score
Time frame: Through study completion, an average of 1 year
Cognitive function-Information Processing Speed index score
Time frame: Through study completion, an average of 1 year
Cognitive function-motor skills index score
Time frame: Through study completion, an average of 1 year
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 4 Jan 2022.
- 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.
Galit Yogev-Seligmann principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing external cues and cogntive movement strategies in people with Parkinson Disease, run by Galit Yogev-Seligmann at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 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 4 Jan 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 Israel. 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?
Gait speed- Physiological measurement of gait (time frame: Through study completion, an average of 1 year). The study lists 5 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 4 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.