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Attending to External Cues and Movement Strategies in Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
external cues and cogntive movement strategies
Sponsored by
Galit Yogev-Seligmann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Parkinson's disease, Gait, Attention, External cues

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for people with Parkinson's disease:

  • Diagnosis of Parkinson's disease
  • Age of 50-85
  • Able to walk independently in daily lives.

Inclusion Criteria for the control group:

  • Age of 50-85
  • Able to walk independently in daily lives.

Exclusion Criteria for people with Parkinson's disease:

  • 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

Exclusion Criteria for the control group:

  • 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

Sites / Locations

  • Galit Yogev-Seligmann

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brain engagement while using compesatory modes for walking

Arm Description

Brain engagemnent (recruitment of attention) is measured during four walking conditions

Outcomes

Primary Outcome Measures

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).
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).
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).
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)
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

Secondary Outcome Measures

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.
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.
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
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.
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.
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.
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.
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.
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
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

Full Information

First Posted
September 1, 2020
Last Updated
January 2, 2022
Sponsor
Galit Yogev-Seligmann
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1. Study Identification

Unique Protocol Identification Number
NCT04674319
Brief Title
Attending to External Cues and Movement Strategies in Parkinson Disease
Official Title
Attending to External Cues and Movement Strategies in Parkinson Disease: Feasibility in Ecological Setting.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Galit Yogev-Seligmann

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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). 2. Evaluation of gait while attending to external cues and cognitive movement strategy. 3. Evaluation of brain engagement during gait 4. Computerized cognitive assessment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Gait, Attention, External cues

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain engagement while using compesatory modes for walking
Arm Type
Experimental
Arm Description
Brain engagemnent (recruitment of attention) is measured during four walking conditions
Intervention Type
Behavioral
Intervention Name(s)
external cues and cogntive movement strategies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gait speed- Physiological measurement of gait
Description
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).
Time Frame
Through study completion, an average of 1 year
Title
Step length- Physiological measurement of gait
Description
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).
Time Frame
Through study completion, an average of 1 year
Title
Cadence- Physiological measurement of gait
Description
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).
Time Frame
Through study completion, an average of 1 year
Title
Swing time percent- Physiological measurement of gait
Description
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)
Time Frame
Through study completion, an average of 1 year
Title
Electrical activity (eeg) of the brain-phisyological measure of electircal signals
Description
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
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Cognitive function Go-NoGo Response Inhibition
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Cognitive function-Stroop Interference
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Cognitive function-Staged Information Processing Speed
Description
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
Time Frame
Through study completion, an average of 1 year
Title
Cognitive function-Finger Tapping
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Cognitive function-'Catch' Game
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Cognitive function-Problem Solving
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Cognitive function-executive function index score
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Cognitive function-Attention index score
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Cognitive function-Information Processing Speed index score
Description
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
Time Frame
Through study completion, an average of 1 year
Title
Cognitive function-motor skills index score
Description
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
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for people with Parkinson's disease: Diagnosis of Parkinson's disease Age of 50-85 Able to walk independently in daily lives. Inclusion Criteria for the control group: Age of 50-85 Able to walk independently in daily lives. Exclusion Criteria for people with Parkinson's disease: 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 Exclusion Criteria for the control group: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galit Yogev-Seligmann
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Galit Yogev-Seligmann
City
Haifa
State/Province
Please Select...
ZIP/Postal Code
3498838
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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Attending to External Cues and Movement Strategies in Parkinson Disease

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