Trial Outcomes & Findings for Visual Function During Gait in Parkinson's Disease: Impact of Cognition and Response to Visual Cues (NCT NCT02610634)
NCT ID: NCT02610634
Last Updated: 2017-10-23
Results Overview
Number of fast eye movements made per second observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
COMPLETED
100 participants
Session 1: observation during gait assessments (lasting approx. 90mins)
2017-10-23
Participant Flow
Participant milestones
| Measure |
Parkinson's Disease
People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
|
Older Adults
Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
40
|
|
Overall Study
COMPLETED
|
60
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Visual Function During Gait in Parkinson's Disease: Impact of Cognition and Response to Visual Cues
Baseline characteristics by cohort
| Measure |
Parkinson's Disease
n=60 Participants
People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
|
Older Adults
n=40 Participants
Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
67.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
60 participants
n=5 Participants
|
40 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins)Number of fast eye movements made per second observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
| Measure |
Parkinson's Disease
n=56 Participants
People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
|
Older Adults
n=40 Participants
Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
|
|---|---|---|
|
Visual Sampling Parameter: Saccade Frequency During Gait
Left Turn with Door dual task
|
0.81 Saccade frequency (sacc/sec)
Standard Deviation 0.53
|
1.18 Saccade frequency (sacc/sec)
Standard Deviation 0.61
|
|
Visual Sampling Parameter: Saccade Frequency During Gait
Straight Walk single task
|
0.48 Saccade frequency (sacc/sec)
Standard Deviation 0.54
|
0.76 Saccade frequency (sacc/sec)
Standard Deviation 0.62
|
|
Visual Sampling Parameter: Saccade Frequency During Gait
Straight Walk with Door single task
|
0.67 Saccade frequency (sacc/sec)
Standard Deviation 0.61
|
0.77 Saccade frequency (sacc/sec)
Standard Deviation 0.57
|
|
Visual Sampling Parameter: Saccade Frequency During Gait
Left Turn with Door single task
|
1.05 Saccade frequency (sacc/sec)
Standard Deviation 0.54
|
1.31 Saccade frequency (sacc/sec)
Standard Deviation 0.60
|
|
Visual Sampling Parameter: Saccade Frequency During Gait
Right Turn with Door single task
|
1.01 Saccade frequency (sacc/sec)
Standard Deviation 0.65
|
1.17 Saccade frequency (sacc/sec)
Standard Deviation 0.74
|
|
Visual Sampling Parameter: Saccade Frequency During Gait
Straight Walk dual task
|
0.31 Saccade frequency (sacc/sec)
Standard Deviation 0.37
|
0.53 Saccade frequency (sacc/sec)
Standard Deviation 0.49
|
|
Visual Sampling Parameter: Saccade Frequency During Gait
Straight Walk with Door dual task
|
0.39 Saccade frequency (sacc/sec)
Standard Deviation 0.39
|
0.60 Saccade frequency (sacc/sec)
Standard Deviation 0.42
|
|
Visual Sampling Parameter: Saccade Frequency During Gait
Right Turn with Door dual task
|
0.69 Saccade frequency (sacc/sec)
Standard Deviation 0.51
|
1.11 Saccade frequency (sacc/sec)
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins)Measured in meters per second observed when walking recorded via Vicon 3D motion capture. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins)Measured in meters recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins)Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins)Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)Number of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins)Velocity (degrees per second) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins)Distance (degrees) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins)Acceleration (degrees per second squared) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins)Number of pauses (fixations) between fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins)Duration (ms) of pauses (fixations) between fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins)Duration (ms) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)Number of blinks observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)The Attention CDR involves a series of computerised tests, which the subjects respond to by pressing one of two buttons. Scores for sub-sections of Simple reaction time, Digit vigilance and Choice reaction time will be obtained.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)JLO is a test of visuospatial ability, which involves a subject viewing a set of numbered lines and then being shown two lines of the same orientation. Participants then have to name the numbers that the shown lines correspond to.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)Participants are required to draw a clock with the numbers and arrows pointed at a particular time. Then the subjects have to copy a clock drawn by the researcher.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)This study will use a selection of these tests; incomplete letters, dot counting and position discrimination.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)VA is measured binocularly used a standard LogMAR chart. Participants will be seated at a distance of 4m from the chart. Participants will be instructed to read aloud down the chart starting from the top left.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)CS will be measured using the Mars CS sheets placed on an adjustable holder. The sheet consists of 48 Latin letters of uniform height; the contrast from the white background decreases with subsequent letters. Room illumination is adjusted so that average CS sheet luminance is between 80 and 120cd/m² (measured via a luminance meter). Assessment is done binocularly with the average distance from the patients eyes being 50cm. Participants read aloud down the sheet starting at the top left. Errors are recorded on the pre-set score sheet and testing is terminated after 2 consecutive errors.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)The Unified Parkinson's Disease Rating Scale will be used to assess motor and non-motor features of PD and disease severity. The UPDRS is scored from a total of 195 points; higher scores reflect worsening disability.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)The Hoehn and Yahr rating scale is a widely used clinical rating scale, which defines broad categories of motor function in Parkinson's disease (PD). All participants' will be tested who are in H \&Y stages I-III.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)This is a 10 item questionnaire intended to classify freezing of gait. The questionnaire has 3 parts; distinction of freezers from non-freezers, Freezing severity, frequency and duration and impact of freezing on daily life.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)Fear of falling will be measured using the falls efficacy scale - international version. This is a short and valid measure of fear of falling in older adults, which assesses basic and demanding activities (both physical and social). It consists of 16 scenarios (e.g. cleaning the house) and subjects must rate their fear of falling on a scale from 1 (Not at all concerned) to 4 (Very concerned).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)Different cognitive domains are assessed (attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)The ACE-R involves testing of attention, orientation, memory, fluency, language and visuospatial abilities.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Session 1 (full session lasts approx. 3 hours)This involves 15 questions about the mood of the subjects. Scores of 0 to 4 to be in the normal range, 5 to 9 to indicate mild depression, and 10 to 15 to indicate moderate to severe depression.
Outcome measures
Outcome data not reported
Adverse Events
Parkinson's Disease
Older Adults
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place