Skip to main content
Clinical Trials/NCT02231073
NCT02231073
Completed
N/A

Peripheral and Central Postural Disorders in the Elderly

Oregon Health and Science University1 site in 1 country94 target enrollmentAugust 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Oregon Health and Science University
Enrollment
94
Locations
1
Primary Endpoint
Change in Mini-BESTest score
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

There is emerging research detailing the relationship between balance/gait/falls and cognition. Imaging studies also suggest a link between structural and functional changes in the frontal lobe (a region commonly associated with cognitive function) and mobility. People with Parkinson's disease have important changes in cognitive function that may impact rehabilitation efficacy. Our underlying hypothesis is that cognitive function and frontal lobe connections with the basal ganglia and brainstem posture/locomotor centers are responsible for postural deficits in people with Parkinson's disease and play a role in rehabilitation efficacy. The purpose of this study is to 1) determine if people with Parkinson's disease can improve mobility and/or cognition after partaking in a cognitively challenging mobility exercise program and 2) determine if cognition and brain circuitry deficits predict responsiveness to exercise rehabilitation.

Design: This study is a randomized cross-over controlled intervention to take place at a University Balance Disorders Laboratory. The study participants will be people with Parkinson's disease who meet inclusion criteria for the study. The intervention will be 6 weeks of group exercise (case) and 6 weeks of group education (control). The exercise is a cognitively challenging program based on the Agility Boot Camp for people with PD. The education program is a 6-week program to teach people how to better live with a chronic disease. The primary outcome measure is the MiniBESTest and the secondary outcomes are measures of mobility, cognition and neural imaging.

Discussion: The results from this study will further our understanding of the relationship between cognition and mobility with a focus on brain circuitry as it relates to rehabilitation potential.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
October 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fay B. Horak

Professor

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Mini-BESTest score

Time Frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)

The Mini-BESTest assesses dynamic balance via a 14-item test that measures multiple domains of balance including anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait.

Secondary Outcomes

  • Change in MDS-UPDRS score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
  • Change in New Freezing of Gait questionnaire (NFOGQ) score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
  • Change in Activities of Balance Confidence (ABC) questionnaire score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
  • Change in instrumented gait and balance measures(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
  • Change in Cognitive measures(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
  • Change in PDQ-39 score(Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2))
  • Neural Imaging(Baseline)

Study Sites (1)

Loading locations...

Similar Trials