Prism Adaptation Treatment of Parkinson's Disease

NCT02380859 | Completed Results

• 1 other identifier: D15047
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Parkinson

Keywords

problems of gait and balance

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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

Secondary Outcomes (4)

• Change in Gait - Step Length on the Walk Across Test (SMART Equitest Balance Master)

  Baseline (Day 0) and Day 15

• Change in Gait - Step Speed in the Walk Across (SMART Equitest Balance Master)

  Baseline (Day 0) and Day 15

• Change in Gait - Timed Up and Go Task

  Baseline (Day 0) and Day 15

• Change in Gait - Functional Gait Assessment

  Baseline (Day 0) and Day 15

Other Outcomes (4)

• Change in Activities of Daily Living - New Freezing of Gait

  Baseline (Day 0) and Day 15

• Change in Activities of Daily Living - Falls Efficiency

  Baseline (Day 0) and Day 15

• Change in Activities of Daily Living - Activity-specific Balance Confidence Scale

  Baseline (Day 0) and Day 15

Study Arms (2)

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.

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.

Behavioral: Prism adaptation

Interventions

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.

Also known as: sensorimotor adaptation, visual adaptation

Prism adaptation; Sham adaptation

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Darmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• 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.

  PMID: 34823572 DERIVED

Results Point of Contact

• Title: Stephen L. Lee, MD PhD
• Organization: Dartmouth-Hitchcock Medical Center

stephen.l.lee@hitchcock.org

603-650-5104

Study Officials

• Stephen L. Lee, MD, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 5, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: November 30, 2017
• Last Updated: March 25, 2019
• Results First Posted: March 25, 2019

Record last verified: 2019-03

Locations

US (1)