Attending to External Cues and Movement Strategies in Parkinson Disease

NCT04674319 | Completed

• 1 other identifier: 052/19
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Gait; Attention; External cues

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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).

  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)

  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

  Through study completion, an average of 1 year

Secondary Outcomes (10)

• 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

Study Arms (1)

Brain engagement while using compesatory modes for walking

EXPERIMENTAL

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

Behavioral: external cues and cogntive movement strategies

Interventions

external cues and cogntive movement strategies BEHAVIORAL

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.

Brain engagement while using compesatory modes for walking

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Galit Yogev-Seligmann: lead

Study Sites (1)

Galit Yogev-Seligmann

Haifa, Please Select..., 3498838, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Galit Yogev-Seligmann

  University of Haifa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: December 19, 2020
• Study Start: March 1, 2019
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2021
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)