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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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Subjects diagnosed with Idiopathic Parkinson's Disease, between ages of 40-85 inclusive, who have been referred for gait training. Since there can be subtle differences in the brain organization of left- and right-handed people that may influence some of the measurements, right handed participants are preferred. However, a left handed participant may be considered. Participants will be randomly assigned to one of two groups to undergo two weeks of twice-daily sessions. Group A receiving goggles fitted with lenses that distort vision and Group B patients receiving sham goggles
The participants will be trained to undergo two daily sessions of visual adaptation at home for 14 consecutive days. For each adaptation session, subject will sit in a chair within reaching distance of a wall or cabinet upon which two dime-sized targets will be placed (one above the other, approximately ten inches apart). While wearing goggles, you will point rapidly to one target then the next, bringing the hand back to his/her torso between each pointing movement. They will be instructed to perform these movements "as quickly as possible" for a total of 50 pointing movements in each treatment session. After performing the 50 pointing movements, they will remove their goggles. Throughout the treatment period they will be asked to keep a diary in which they will log the time and duration of each prism adaptation session. At the first and second site visits, participants will be assessed for posture, gait and activities of daily living which will include some questionnaires. Questionnaires will be sent via mail after post-treatment at one week,1 month and 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prism adaptation | Active Comparator | Patients will undergo twice daily adaptation to upward shifts in vision. Participants will be provided with goggles fitted with prismatic lenses that shift vision upward by 25 dioptres (about 17 degrees). While wearing the lenses, participants point to two 10cm-diameter visual targets positioned one above the other (about 20cm apart) on a wall, returning their pointing arm to their chest between each pointing movement. Participants make 50 pointing movements, as fast and as accurately as possible. Such a procedure induces a downward sensorimotor adaptation of pointing movements. Participants undergo this training twice a day (morning and evening) for two weeks in a self-guided fashion. |
|
| Sham adaptation | Sham Comparator | Participants undergo the same treatment protocol as described in the active comparator arm, with the exception that they wear goggles fitted with neutral lenses that do not induce sensorimotor adaptation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prism adaptation | Behavioral | Prism adaptation is one type of sensorimotor adaptation. Prism adaptation described any adaptation to a prismatic shift in vision (i.e. any magnitude or direction of shift). In this study we are using adaptation to upward-shifting prisms, which induces a downward sensorimotor after-effect. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Postural Control - Reaction Time on the Limits of Stability Test (Smart Equitest Balance Master System) | The participant stood on the platform in front of a monitor. Nine squares were presented on the monitor representing locations relative to the upright starting position: one in the centre of the screen (upright) and the remaining eight forming an ellipse around the central square. The participant's COG was indicated on the screen by the position of a stick figure avatar. At the beginning of each trial the participant was instructed to stand upright, keeping the COG cursor over the central target. A circular target appeared in one of eight other targets. The participant was required to move the COG cursor towards the second target as quickly and as accurately as possible by leaning their body while keeping their feet in the same location, and to then hold a position as close to the target as possible. Reacting times were recorded for 8 trials per location. Mean change (post-pre) in seconds | Baseline (Day 0) and Day 15 |
| Change in Postural Control - Maximum Velocity on the Limits of Stability Test (Smart Equitest Balance Master System) | The participant stood on the platform in front of a monitor. Nine squares were presented on the monitor representing locations relative to the upright starting position: one in the centre of the screen (upright) and the remaining eight forming an ellipse around the central square. The participant's COG was indicated on the screen by the position of a stick figure avatar. At the beginning of each trial the participant was instructed to stand upright, keeping the COG cursor over the central target. A circular target appeared in one of eight other targets. The participant was required to move the COG cursor towards the second target as quickly and as accurately as possible by leaning their body while keeping their feet in the same location, and to then hold a position as close to the target as possible. Maximum velocity was recorded for 8 trials per location. | Baseline (Day 0) and Day 15 |
| Change in Postural Control - Maximum Extension on the Limits of Stability Test (Smart Equitest Balance Master System) | The participant stood on the platform in front of a monitor. Nine squares were presented on the monitor representing locations relative to the upright starting position: one in the centre of the screen (upright) and the remaining eight forming an ellipse around the central square. The participant's COG was indicated on the screen by the position of a stick figure avatar. At the beginning of each trial the participant was instructed to stand upright, keeping the COG cursor over the central target. A circular target appeared in one of eight other targets. The participant was required to move the COG cursor towards the second target as quickly and as accurately as possible by leaning their body while keeping their feet in the same location, and to then hold a position as close to the target as possible. Maximum extension of the COG over the feet was recorded for 8 trials per location. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gait - Step Length on the Walk Across Test (SMART Equitest Balance Master) | The WA quantifies characteristics of gait as the patient walks across the length of the force plate. The test characterizes steady state gait by having the patient begin well behind and continuing beyond the force plate. Measured parameters are average step width, average step length, speed and step length symmetry. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Activities of Daily Living - New Freezing of Gait | Average change in score relating to new freezing of gate utilizing the New Freezing of Gait Questionnaire. This nine-item questionnaire detects and evaluates the impact and severity of freezing of gait on locomotion and daily activities. Items are scored from 0 or 1 to 3 or 4, with higher numbers indicating greater impact and severity. A total score out of 28 is calculated. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen L. Lee, MD, PhD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Darmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34823572 | Derived | Bultitude JH, Pidgeon DM, LeBlanc PR, Jeffreys CA, Alexandre FP, Lee SL. Two weeks of twice-daily prism adaptation treatment does not improve posture or gait in Parkinson's disease: a double-blind randomized controlled trial. Trials. 2021 Nov 25;22(1):846. doi: 10.1186/s13063-021-05832-2. |
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There was a protocol violation in our intended randomization procedure in that participants were randomized to treatment or control groups with replacement instead of without replacement. This resulted in uneven group numbers, rather than the equal group numbers that was intended.
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| ID | Title | Description |
|---|---|---|
| FG000 | Real Prism Adaptation | Participants were randomized to undergo treatment that involved adaptation to 15º upward shifts in vision. |
| FG001 | Sham Prism Adaptation | Participants were randomized to placebo lenses that distorted vision without vertical shift. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Real Prism Adaptation | Participants were randomized to treatment prisms, designed to shift vertical orientation slightly by 1.5 degrees |
| BG001 | Sham Prism Adaptation | Participants were randomized to placebo lenses that distorted vision without vertical shift. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Postural Control - Reaction Time on the Limits of Stability Test (Smart Equitest Balance Master System) | The participant stood on the platform in front of a monitor. Nine squares were presented on the monitor representing locations relative to the upright starting position: one in the centre of the screen (upright) and the remaining eight forming an ellipse around the central square. The participant's COG was indicated on the screen by the position of a stick figure avatar. At the beginning of each trial the participant was instructed to stand upright, keeping the COG cursor over the central target. A circular target appeared in one of eight other targets. The participant was required to move the COG cursor towards the second target as quickly and as accurately as possible by leaning their body while keeping their feet in the same location, and to then hold a position as close to the target as possible. Reacting times were recorded for 8 trials per location. Mean change (post-pre) in seconds | Posted | Mean | Standard Deviation | Seconds | Baseline (Day 0) and Day 15 |
|
From consent until study completion, approximately 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Real Prism Adaptation | Participants were randomized to undergo treatment that involved adaptation to 15º upward shifts in vision. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concusion | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen L. Lee, MD PhD | Dartmouth-Hitchcock Medical Center | 603-650-5104 | stephen.l.lee@hitchcock.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2014 | Apr 11, 2018 | Prot_SAP_000.pdf |
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| Baseline (Day 0) and Day 15 |
| Change in Postural Control - Composite Score on the Sensory Organisation Test SMART EquiTest Balance Master | The participant is asked to maintain an upright posture under six different conditions of sensory feedback:
The equilibrium score for each condition compares the subject's anterior/posterior (AP) sway during each trial to the theoretical sway stability limit of 12.5 degrees. A composite equilibrium score (0-100, higher score indicates better outcome) quantifies the overall COG sway or postural stability across the sensory conditions and is calculated by:
| Baseline (Day 0) and Day 15 |
| Change in Postural Control - Forward-backward Displacement of Centre of Gravity on the Sensory Organisation Test SMART EquiTest Balance Master | The participant is asked to maintain an upright posture under different conditions of sensory feedback. Proprioceptive feedback to the feet and joints is manipulated by allowing the platform to tilt to directly follow the participant's anteroposterior body sway (constant proprioception) or by maintaining the standing platform in a fixed horizontal position (normal proprioceptive feedback). Visual feedback is provided by asking the participant to close their eyes (no visual feedback), asking the participant to open their eyes and allowing the visual surround to tilt directly following the participant's anterioposterior body sway (constant visual feedback), or by asking the participant to keep their eyes open and maintaining the visual surround in a fixed position (normal visual feedback). Forward-backward displacement of COG is recorded in degrees. | Baseline (Day 0) and Day 15 |
| Change in Postural Control - Composite Latency Score on the Motor Control Test | The MCT assesses the ability of the automatic motor system to quickly recover following an unexpected external disturbance. Sequences of small, medium or large platform translations (scaled to the patient's height) in forward and backward directions elicit automatic postural responses. Translation of the surface in one horizontal direction results in displacement of the COG away from center in the opposite direction relative to the base of support. To restore normal balance, a quick movement of the COG back to the center position is required. A composite latency value is provided as the time in milliseconds between the force plate translation and the patient's active corrective responses, averaged across all translation sizes and directions. | Baseline (Day 0) and Day 15 |
| Change in Postural Control - Composite Latency Score on the Berg Balance Scale | Berg Balance Scale. This 14-item test assesses balance during different tasks. Items consist of specific items such as standing with eyes closed, retrieving an object from the floor, and turning to look behind. The assessor rates the patient's performance from 0 ("lowest level of function") to 4 ("highest level of function") and a total is calculated out of a maximum score of 56. | Baseline (Day 0) and Day 15 |
| Baseline (Day 0) and Day 15 |
| Change in Gait - Step Speed in the Walk Across (SMART Equitest Balance Master) | The WA quantifies characteristics of gait as the patient walks across the length of the force plate. The test characterizes steady state gait by having the patient begin well behind and continuing beyond the force plate. Measured parameters are average step width, average step length, speed and step length symmetry. | Baseline (Day 0) and Day 15 |
| Change in Gait - Timed Up and Go Task | Timed Up and Go Test (TUG). Patients are seated in a chair and instructed to stand up, walk three meters, turn around, walk back, and sit down. The time (in seconds) is recorded. | Baseline (Day 0) and Day 15 |
| Change in Gait - Functional Gait Assessment | Functional Gait Assessment. This 10-item test assesses dynamic balance and postural stability during gait. Items consist of specific walking tasks such as stepping over an obstacle, changing speed of walking upon the assessor's instruction, and walking backwards. The assessor scores the patient's performance from 0 ("severe impairment") to 3 ("normal") and a total is calculated out of 30. | Baseline (Day 0) and Day 15 |
| Baseline (Day 0) and Day 15 |
| Change in Activities of Daily Living - Falls Efficiency | Average change in score evaluated using the Falls Efficiency Scale. This ten-item questionnaire asks people to rate their confidence in performing daily activities without falling. Responses are given on a scale from 0 ("very confident") to 10 ("not very confident") and a total score out of 100 is computed. | Baseline (Day 0) and Day 15 |
| Change in Activities of Daily Living - Activity-specific Balance Confidence Scale | Activities-specific Balance Confidence Scale. This 16-item questionnaire is similar to the Falls Efficiency Scale, but has greater sensitivity to gait impairments in more ambulatory patients. Responses are given on a scale from 0 ("very confident") to 10 "not very confident") and a total score out of 100 is computed. | Baseline (Day 0) and Day 15 |
| Change in Activities of Daily Living - Parkinson's Disease Questionnaire | Parkinson's Disease Questionnaire (PDQ-39), mobility and activities of daily living sections. This 39-item questionnaire is the most widely-used Parkinson's Disease specific measure of health and daily function. Participants indicate the extent to which they have experienced problems with different aspects of mobility and self-care. Each item is scored from 0 ("never have problems") to 4 ("always have problems"), and a percentage is calculated. In addition to the total score, the mobility (questions 1-10) and activities of daily living (questions 11-16) sub-sections can be analysed separately to assess changes in these specific outcomes. The responses are summed and scored as a percentage. We analysed the percentage scores for the mobility sub-section, the activities of daily living sub-section, and the total percentage. Higher values indicate worse outcome. | Baseline (Day 0) and Day 15 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Real Prism Adaptation |
Participants were randomized to undergo treatment that involved adaptation to 15º upward shifts in vision. |
| OG001 | Sham Prism Adaptation | Participants were randomized to placebo lenses that distorted vision without vertical shift |
|
|
| Primary | Change in Postural Control - Maximum Velocity on the Limits of Stability Test (Smart Equitest Balance Master System) | The participant stood on the platform in front of a monitor. Nine squares were presented on the monitor representing locations relative to the upright starting position: one in the centre of the screen (upright) and the remaining eight forming an ellipse around the central square. The participant's COG was indicated on the screen by the position of a stick figure avatar. At the beginning of each trial the participant was instructed to stand upright, keeping the COG cursor over the central target. A circular target appeared in one of eight other targets. The participant was required to move the COG cursor towards the second target as quickly and as accurately as possible by leaning their body while keeping their feet in the same location, and to then hold a position as close to the target as possible. Maximum velocity was recorded for 8 trials per location. | Average change time; mean change (post-pre) meters per second | Posted | Mean | Standard Deviation | meters per second | Baseline (Day 0) and Day 15 |
|
|
|
|
| Primary | Change in Postural Control - Maximum Extension on the Limits of Stability Test (Smart Equitest Balance Master System) | The participant stood on the platform in front of a monitor. Nine squares were presented on the monitor representing locations relative to the upright starting position: one in the centre of the screen (upright) and the remaining eight forming an ellipse around the central square. The participant's COG was indicated on the screen by the position of a stick figure avatar. At the beginning of each trial the participant was instructed to stand upright, keeping the COG cursor over the central target. A circular target appeared in one of eight other targets. The participant was required to move the COG cursor towards the second target as quickly and as accurately as possible by leaning their body while keeping their feet in the same location, and to then hold a position as close to the target as possible. Maximum extension of the COG over the feet was recorded for 8 trials per location. | Average change in Maximum Extension between baseline and day 15 | Posted | Mean | Standard Deviation | meters | Baseline (Day 0) and Day 15 |
|
|
|
| Primary | Change in Postural Control - Composite Score on the Sensory Organisation Test SMART EquiTest Balance Master | The participant is asked to maintain an upright posture under six different conditions of sensory feedback:
The equilibrium score for each condition compares the subject's anterior/posterior (AP) sway during each trial to the theoretical sway stability limit of 12.5 degrees. A composite equilibrium score (0-100, higher score indicates better outcome) quantifies the overall COG sway or postural stability across the sensory conditions and is calculated by:
| Posted | Mean | Standard Deviation | change in percentage | Baseline (Day 0) and Day 15 |
|
|
|
| Secondary | Change in Gait - Step Length on the Walk Across Test (SMART Equitest Balance Master) | The WA quantifies characteristics of gait as the patient walks across the length of the force plate. The test characterizes steady state gait by having the patient begin well behind and continuing beyond the force plate. Measured parameters are average step width, average step length, speed and step length symmetry. | Posted | Mean | Standard Deviation | cm | Baseline (Day 0) and Day 15 |
|
|
|
| Secondary | Change in Gait - Step Speed in the Walk Across (SMART Equitest Balance Master) | The WA quantifies characteristics of gait as the patient walks across the length of the force plate. The test characterizes steady state gait by having the patient begin well behind and continuing beyond the force plate. Measured parameters are average step width, average step length, speed and step length symmetry. | Posted | Mean | Standard Deviation | cm/s | Baseline (Day 0) and Day 15 |
|
|
|
| Secondary | Change in Gait - Timed Up and Go Task | Timed Up and Go Test (TUG). Patients are seated in a chair and instructed to stand up, walk three meters, turn around, walk back, and sit down. The time (in seconds) is recorded. | Posted | Mean | Standard Deviation | seconds | Baseline (Day 0) and Day 15 |
|
|
|
| Secondary | Change in Gait - Functional Gait Assessment | Functional Gait Assessment. This 10-item test assesses dynamic balance and postural stability during gait. Items consist of specific walking tasks such as stepping over an obstacle, changing speed of walking upon the assessor's instruction, and walking backwards. The assessor scores the patient's performance from 0 ("severe impairment") to 3 ("normal") and a total is calculated out of 30. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Day 0) and Day 15 |
|
|
|
| Other Pre-specified | Change in Activities of Daily Living - New Freezing of Gait | Average change in score relating to new freezing of gate utilizing the New Freezing of Gait Questionnaire. This nine-item questionnaire detects and evaluates the impact and severity of freezing of gait on locomotion and daily activities. Items are scored from 0 or 1 to 3 or 4, with higher numbers indicating greater impact and severity. A total score out of 28 is calculated. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Day 0) and Day 15 |
|
|
|
| Other Pre-specified | Change in Activities of Daily Living - Falls Efficiency | Average change in score evaluated using the Falls Efficiency Scale. This ten-item questionnaire asks people to rate their confidence in performing daily activities without falling. Responses are given on a scale from 0 ("very confident") to 10 ("not very confident") and a total score out of 100 is computed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Day 0) and Day 15 |
|
|
|
| Other Pre-specified | Change in Activities of Daily Living - Activity-specific Balance Confidence Scale | Activities-specific Balance Confidence Scale. This 16-item questionnaire is similar to the Falls Efficiency Scale, but has greater sensitivity to gait impairments in more ambulatory patients. Responses are given on a scale from 0 ("very confident") to 10 "not very confident") and a total score out of 100 is computed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Day 0) and Day 15 |
|
|
|
| Other Pre-specified | Change in Activities of Daily Living - Parkinson's Disease Questionnaire | Parkinson's Disease Questionnaire (PDQ-39), mobility and activities of daily living sections. This 39-item questionnaire is the most widely-used Parkinson's Disease specific measure of health and daily function. Participants indicate the extent to which they have experienced problems with different aspects of mobility and self-care. Each item is scored from 0 ("never have problems") to 4 ("always have problems"), and a percentage is calculated. In addition to the total score, the mobility (questions 1-10) and activities of daily living (questions 11-16) sub-sections can be analysed separately to assess changes in these specific outcomes. The responses are summed and scored as a percentage. We analysed the percentage scores for the mobility sub-section, the activities of daily living sub-section, and the total percentage. Higher values indicate worse outcome. | Posted | Mean | Standard Deviation | percentage | Baseline (Day 0) and Day 15 |
|
|
|
| Primary | Change in Postural Control - Forward-backward Displacement of Centre of Gravity on the Sensory Organisation Test SMART EquiTest Balance Master | The participant is asked to maintain an upright posture under different conditions of sensory feedback. Proprioceptive feedback to the feet and joints is manipulated by allowing the platform to tilt to directly follow the participant's anteroposterior body sway (constant proprioception) or by maintaining the standing platform in a fixed horizontal position (normal proprioceptive feedback). Visual feedback is provided by asking the participant to close their eyes (no visual feedback), asking the participant to open their eyes and allowing the visual surround to tilt directly following the participant's anterioposterior body sway (constant visual feedback), or by asking the participant to keep their eyes open and maintaining the visual surround in a fixed position (normal visual feedback). Forward-backward displacement of COG is recorded in degrees. | Posted | Mean | Standard Deviation | Degrees | Baseline (Day 0) and Day 15 |
|
|
|
| Primary | Change in Postural Control - Composite Latency Score on the Motor Control Test | The MCT assesses the ability of the automatic motor system to quickly recover following an unexpected external disturbance. Sequences of small, medium or large platform translations (scaled to the patient's height) in forward and backward directions elicit automatic postural responses. Translation of the surface in one horizontal direction results in displacement of the COG away from center in the opposite direction relative to the base of support. To restore normal balance, a quick movement of the COG back to the center position is required. A composite latency value is provided as the time in milliseconds between the force plate translation and the patient's active corrective responses, averaged across all translation sizes and directions. | Posted | Mean | Standard Deviation | ms | Baseline (Day 0) and Day 15 |
|
|
|
| Primary | Change in Postural Control - Composite Latency Score on the Berg Balance Scale | Berg Balance Scale. This 14-item test assesses balance during different tasks. Items consist of specific items such as standing with eyes closed, retrieving an object from the floor, and turning to look behind. The assessor rates the patient's performance from 0 ("lowest level of function") to 4 ("highest level of function") and a total is calculated out of a maximum score of 56. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Day 0) and Day 15 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Sham Prism Adaptation | Participants were randomized to placebo lenses that distorted vision without vertical shift. | 0 | 13 | 0 | 13 | 2 | 13 |
| Freezing | Nervous system disorders | Systematic Assessment | Foot Froze and balance was affected |
|
| Blurry Vision/Dizzy | Nervous system disorders | Systematic Assessment |
|
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| Total (%) |
|