N/A
N=32
Prism Adaptation Treatment of Parkinson's Disease
Parkinson
Bottom Line
View on ClinicalTrials.gov: NCT02380859 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Change in Postural Control - Reaction Time on the Limits of Stability Test (Smart Equitest Balance Master System) — 0.09; -0.02 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prism adaptation (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Postural Control - Reaction Time on the Limits of Stability Test (Smart Equitest Balance Master System) |
0.09; -0.02 | — |
| PRIMARY Change in Postural Control - Maximum Velocity on the Limits of Stability Test (Smart Equitest Balance Master System) |
0.54; 0.11 | 0.005 sig |
| PRIMARY Change in Postural Control - Maximum Extension on the Limits of Stability Test (Smart Equitest Balance Master System) |
3.0; 0.63 | — |
| PRIMARY Change in Postural Control - Composite Score on the Sensory Organisation Test SMART EquiTest Balance Master |
4.3; 2.5 | — |
| PRIMARY Change in Postural Control - Forward-backward Displacement of Centre of Gravity on the Sensory Organisation Test SMART EquiTest Balance Master |
0.05; -0.12 | — |
| PRIMARY Change in Postural Control - Composite Latency Score on the Motor Control Test |
1.9; 2.1 | — |
| PRIMARY Change in Postural Control - Composite Latency Score on the Berg Balance Scale |
0.38; -0.69 | — |
| SECONDARY Change in Gait - Step Length on the Walk Across Test (SMART Equitest Balance Master) |
-3.0; -4.1 | — |
| SECONDARY Change in Gait - Step Speed in the Walk Across (SMART Equitest Balance Master) |
5.0; 1.3 | — |
| SECONDARY Change in Gait - Timed Up and Go Task |
-1.8; -0.25 | — |
| SECONDARY Change in Gait - Functional Gait Assessment |
1.8; 1.0 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02380859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.