Clinical trial NCT04674319: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Gait
Attention
External cues
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Gait speed- Physiological measurement of gait
timeFrame: Through study completion, an average of 1 year
measure: Step length- Physiological measurement of gait
timeFrame: Through study completion, an average of 1 year
measure: Cadence- Physiological measurement of gait
timeFrame: Through study completion, an average of 1 year
measure: Swing time percent- Physiological measurement of gait
timeFrame: Through study completion, an average of 1 year
measure: Electrical activity (eeg) of the brain-phisyological measure of electircal signals
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Cognitive function Go-NoGo Response Inhibition
timeFrame: Through study completion, an average of 1 year
measure: Cognitive function-Stroop Interference
timeFrame: Through study completion, an average of 1 year
measure: Cognitive function-Staged Information Processing Speed
timeFrame: Through study completion, an average of 1 year
measure: Cognitive function-Finger Tapping
timeFrame: Through study completion, an average of 1 year
measure: Cognitive function-'Catch' Game
timeFrame: Through study completion, an average of 1 year
measure: Cognitive function-Problem Solving
timeFrame: Through study completion, an average of 1 year
measure: Cognitive function-executive function index score
timeFrame: Through study completion, an average of 1 year
measure: Cognitive function-Attention index score
timeFrame: Through study completion, an average of 1 year
measure: Cognitive function-Information Processing Speed index score
timeFrame: Through study completion, an average of 1 year
measure: Cognitive function-motor skills index score
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Galit Yogev-Seligmann
state: Please Select...
Study officials:
affiliation: University of Haifa
name: Galit Yogev-Seligmann
role: PRINCIPAL_INVESTIGATOR
References: