ParkinsonNCT02380859
Prism Adaptation Treatment of Parkinson's Disease
A study testing Prism adaptation in people with Parkinson, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson
- What is being tested?
- Prism adaptation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's Disease
- Referral for gait training
- Aged 40 -85
- If the subject is taking CNS-acting medications (benzodiazepines, hypnotics, antidepressants), regimen must be stable for 30 days prior to baseline visit
- Subjects with Stage 11.5 - Stage IV (Hoehn and Yahr scale) where stage II.5 is bilateral involvement with axial involvements, but without balance difficulty, to Stage IV where one has severe disability but is still able to walk or stand unassisted
- Subjects with any of the following abnormal scores (greater than 0) in the MDS-UPDRS Part III; a) Part III.10 Gait; b) Part III.11 Freezing of gait c) Part III.12 Postural Stability; subjects with Timed up and go test >12 seconds
- Right handed participants are preferred due to the cortical lateralization of functions related to sensorimotor adaptation and postural control.
- However, we will recruit left-handed participants if there are insufficient right-handed volunteers.
Who cannot join
- Subjects with a known psychiatric comorbidity that in the investigator's opinion would compromise participation in the study; subjects with a neurologic diagnosis, other than Parkinson's disease that can cause imbalance and gait impairment (e.g., multiple sclerosis, stroke, subdural hematoma, peripheral neuropathy)
- Injury or impairment to the right arm (other than that which is due to Parkinson's disease) that would affect pointing movements; subjects with normal score on UPDRS part III
- Classified as legally blind or lacking sufficient visual acuity to view the target and pointing hand during prism adaptation
- Lacking sufficient understanding of verbal and written information in English to complete any of the consent screening forms.
Trial locations and contacts
1 site in 1 country.
United States1 site
Darmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Treatment of Gait Disturbance in Parkinson's Disease With Prism Adaptation
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
Read the detailed description
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.
- Conditions
- Parkinson
- Being tested
- Prism adaptation
- Keywords
- problems of gait and balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism adaptationBehavioural
Also called sensorimotor adaptation, visual adaptation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Prism adaptation |
| 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. Receives: Behavioral: Prism adaptation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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:
- Condition 1:Normal vision, fixed support
- Condition 2:Absent vision, fixed support
- Condition 3:Sway-referenced vision, fixed support
- Condition 4:Normal vision, sway-referenced support
- Condition 5:Absent vision, sway-referenced support
- Condition 6:Sway-referenced vision, sway-referenced support
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:
- Independently averaging the score for conditions 1 and 2;
- Adding these two scores to the equilibrium scores from each trial of sensory conditions 3, 4, 5, and 6; and
- Dividing that sum by the total number of trials.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0) and Day 15
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0) and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Stephen L. Lee, Dartmouth-Hitchcock Medical Center
- Investigators
- Stephen L. Lee, MD, PhD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380859
- Sponsor's protocol ID
- D15047
- Status last verified
- Mar 2019
- First submitted
- 24 Feb 2015
- Last updated
- 25 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34823572
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Gait Disturbance in Parkinson's Disease With Prism Adaptation
- ClinicalTrials.gov ID
- NCT02380859
- Acronym / sponsor ID
- D15047
- Conditions
- Parkinson
- Keywords
- problems of gait and balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Feb 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Posted 25 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prism adaptation | Active comparator | Behavioral: Prism adaptationPatients 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 | Behavioral: Prism adaptationParticipants 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of idiopathic Parkinson's Disease
- Referral for gait training
- Aged 40 -85
- If the subject is taking CNS-acting medications (benzodiazepines, hypnotics, antidepressants), regimen must be stable for 30 days prior to baseline visit
- Subjects with Stage 11.5 - Stage IV (Hoehn and Yahr scale) where stage II.5 is bilateral involvement with axial involvements, but without balance difficulty, to Stage IV where one has severe disability but is still able to walk or stand unassisted
Key exclusion criteria (4 listed)
- Subjects with a known psychiatric comorbidity that in the investigator's opinion would compromise participation in the study; subjects with a neurologic diagnosis, other than Parkinson's disease that can cause imbalance and gait impairment (e.g., multiple sclerosis, stroke, subdural hematoma, peripheral neuropathy)
- Injury or impairment to the right arm (other than that which is due to Parkinson's disease) that would affect pointing movements; subjects with normal score on UPDRS part III
- Classified as legally blind or lacking sufficient visual acuity to view the target and pointing hand during prism adaptation
- Lacking sufficient understanding of verbal and written information in English to complete any of the consent screening forms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prism adaptationAlso: sensorimotor adaptation, visual adaptationPrism 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. | Behavioural | Prism adaptation, Sham adaptation |
Primary outcome
Change in Postural Control - Reaction Time on the Limits of Stability Test (Smart Equitest Balance Master System)
Time frame: Baseline (Day 0) and Day 15
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
Change in Postural Control - Maximum Velocity on the Limits of Stability Test (Smart Equitest Balance Master System)
Time frame: Baseline (Day 0) and Day 15
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.
Change in Postural Control - Maximum Extension on the Limits of Stability Test (Smart Equitest Balance Master System)
Time frame: Baseline (Day 0) and Day 15
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.
Change in Postural Control - Composite Score on the Sensory Organisation Test SMART EquiTest Balance Master
Time frame: Baseline (Day 0) and Day 15
The participant is asked to maintain an upright posture under six different conditions of sensory feedback: * Condition 1:Normal vision, fixed support * Condition 2:Absent vision, fixed support * Condition 3:Sway-referenced vision, fixed support * Condition 4:Normal vision, sway-referenced support * Condition 5:Absent vision, sway-referenced support * Condition 6:Sway-referenced vision, sway-referenced support 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: * Independently averaging the score for conditions 1 and 2; * Adding these two scores to the equilibrium scores from each trial of sensory conditions 3, 4, 5, and 6; and * Dividing that sum by the total number of trials.
Change in Postural Control - Forward-backward Displacement of Centre of Gravity on the Sensory Organisation Test SMART EquiTest Balance Master
Time frame: Baseline (Day 0) and Day 15
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.
Change in Postural Control - Composite Latency Score on the Motor Control Test
Time frame: Baseline (Day 0) and Day 15
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.
Change in Postural Control - Composite Latency Score on the Berg Balance Scale
Time frame: Baseline (Day 0) and Day 15
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.
4 secondary outcomes
Change in Gait - Step Length on the Walk Across Test (SMART Equitest Balance Master)
Time frame: Baseline (Day 0) and Day 15
Change in Gait - Step Speed in the Walk Across (SMART Equitest Balance Master)
Time frame: Baseline (Day 0) and Day 15
Change in Gait - Timed Up and Go Task
Time frame: Baseline (Day 0) and Day 15
Change in Gait - Functional Gait Assessment
Time frame: Baseline (Day 0) and Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34823572Bultitude 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen L. Lee, MD, PhD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prism adaptation in people with Parkinson, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postural Control - Reaction Time on the Limits of Stability Test (Smart Equitest Balance Master System) (time frame: Baseline (Day 0) and Day 15). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02380859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.