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Clinical Trials/NCT04674319
NCT04674319
Completed
Not Applicable

Attending to External Cues and Movement Strategies in Parkinson Disease: Feasibility in Ecological Setting.

Galit Yogev-Seligmann1 site in 1 country15 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Galit Yogev-Seligmann
Enrollment
15
Locations
1
Primary Endpoint
Swing time percent- Physiological measurement of gait
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
August 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Galit Yogev-Seligmann
Responsible Party
Sponsor Investigator
Principal Investigator

Galit Yogev-Seligmann

Prinicipal Investigator

University of Haifa

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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).

Secondary Outcomes

  • Cognitive function Go-NoGo Response Inhibition(Through study completion, an average of 1 year)
  • Cognitive function-Stroop Interference(Through study completion, an average of 1 year)
  • Cognitive function-Staged Information Processing Speed(Through study completion, an average of 1 year)
  • Cognitive function-Finger Tapping(Through study completion, an average of 1 year)
  • Cognitive function-'Catch' Game(Through study completion, an average of 1 year)
  • Cognitive function-Problem Solving(Through study completion, an average of 1 year)
  • Cognitive function-executive function index score(Through study completion, an average of 1 year)
  • Cognitive function-Attention index score(Through study completion, an average of 1 year)
  • Cognitive function-Information Processing Speed index score(Through study completion, an average of 1 year)
  • Cognitive function-motor skills index score(Through study completion, an average of 1 year)

Study Sites (1)

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