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A Home Program Using Multimodal Sensory Feedback for People With Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise+multi-modal sensory feedback (MMSF)
Exercise only
Sponsored by
Regis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring multimodal, real-time feedback, automaticity, gait, balance

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Medical diagnosis of Parkinson Disease
  • A score of 26 or higher on the Mini-Mental Status Exam
  • Able to stand from sitting and take 5 steps without assistance
  • People who have been on the same dosages of medication for PD for 3 weeks or longer

Exclusion Criteria:

  • Participating in an exercise program for less than 3 months
  • Plans to change a current exercise program during the study
  • Changes in medications that affect PD or its sequelea

Sites / Locations

  • Regis University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

exercise+MMSF

exercise only

Arm Description

Group of PWPD who performed a base exercise program of speed and large amplitude stepping and standing balance exercises with Multimodal real-time sensory feedback

Group PWPD who did the same exercise program without MMSF

Outcomes

Primary Outcome Measures

Changes in temporalspatial components of Gait
temporal and spacial components of gait measured with Gaitrite Mat
changes in balance
single leg stance time, time standing on foam eyes closed, Mini-BESTest
Change in cognitive attention needed for gait
3 meter walk test performed at comfortable gait speed once and repeated while subtracting 3s from 100 to assess cognitive attention needed for walking tasks (automaticity)
Change in perceived difficulty during gait and ADLs,
Parkinson Disease Questionnaire (PDQ-39)

Secondary Outcome Measures

Full Information

First Posted
December 2, 2019
Last Updated
January 7, 2020
Sponsor
Regis University
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1. Study Identification

Unique Protocol Identification Number
NCT04223245
Brief Title
A Home Program Using Multimodal Sensory Feedback for People With Parkinson Disease
Official Title
A Comparison Of Home Exercises With Multimodal Real-time Sensory Feedback To The Same Exercise Program With No Enhanced Feedback on Walking Automaticity in People With Parkinson Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
October 17, 2018 (Actual)
Study Completion Date
March 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
People with Parkinson Disease (PWPD) have significant problems with velocity, safety and dual tasking during walking that may be secondary to poor automaticity. Sensory functions, especially visual dependence and proprioceptive integration are critical for efficient walking and are often impaired. This home program compares the use of multimodal sensory feedback during stepping and balance exercises in PWPD to a group without the sensory feedback performing the same basic exercises.
Detailed Description
Parkinson disease impairs motor and sensory functions. Automaticity of gait is lost increasing the use of higher center control of walking, leading to cognitive fatigue, slower movement and motor errors. People with Parkinson disease (PWPD) improve motor performance when external sensory cues, which bypass the faulty basal ganglia, are used during interventions. Enhancing proprioceptive, visual and vestibular cues that are critical for walking has the potential to improve gait and decrease cognitive fatigue by restoring automaticity. This is a single-blinded randomized controlled study with repeated measures to evaluate the effects of a home exercise program with or without the addition of multi-modal sensory feedback (MMSF) in real-time on automaticity of gait and balance. PWPDs are randomly assigned to one of 2 home exercise groups. There are two 6 week exercise sessions with a 6 week of no exercises inter-spaced between them. The exercises promote rapid and large movement in stepping activities, balance using self-perturbation through single, leg swings and standing on a compliant surface for sensory re-weighting. People in the experimental group perform the program with real-time with MMSF. Participants are to progress exercises in speed and distance as well as performing with eyes closed to improve proprioceptive processing and automaticity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
multimodal, real-time feedback, automaticity, gait, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind randomized trial with 2 groups
Masking
Outcomes Assessor
Masking Description
blinded to subject group assignment
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise+MMSF
Arm Type
Experimental
Arm Description
Group of PWPD who performed a base exercise program of speed and large amplitude stepping and standing balance exercises with Multimodal real-time sensory feedback
Arm Title
exercise only
Arm Type
Active Comparator
Arm Description
Group PWPD who did the same exercise program without MMSF
Intervention Type
Behavioral
Intervention Name(s)
exercise+multi-modal sensory feedback (MMSF)
Intervention Description
home program of 3 stepping exercises and 3 balance exercises with progression of speed, step distance and reduced vision. Real-time sensory feedback during ex. using ankle, wrist wts., laser on chest and mat with footpads and clickers (auditory feedback during stepping)
Intervention Type
Behavioral
Intervention Name(s)
Exercise only
Intervention Description
3 stepping and 3 balance exercises which are to progress in speed and distance of movement as well as progress to eyes closed while performing.
Primary Outcome Measure Information:
Title
Changes in temporalspatial components of Gait
Description
temporal and spacial components of gait measured with Gaitrite Mat
Time Frame
baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
Title
changes in balance
Description
single leg stance time, time standing on foam eyes closed, Mini-BESTest
Time Frame
baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
Title
Change in cognitive attention needed for gait
Description
3 meter walk test performed at comfortable gait speed once and repeated while subtracting 3s from 100 to assess cognitive attention needed for walking tasks (automaticity)
Time Frame
Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
Title
Change in perceived difficulty during gait and ADLs,
Description
Parkinson Disease Questionnaire (PDQ-39)
Time Frame
Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Medical diagnosis of Parkinson Disease A score of 26 or higher on the Mini-Mental Status Exam Able to stand from sitting and take 5 steps without assistance People who have been on the same dosages of medication for PD for 3 weeks or longer Exclusion Criteria: Participating in an exercise program for less than 3 months Plans to change a current exercise program during the study Changes in medications that affect PD or its sequelea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia A Winkler, PT, DSc
Organizational Affiliation
Regis University, 3333 Regis Blvd , Denver, Co 80221
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regis University
City
Denver
State/Province
Colorado
ZIP/Postal Code
80221
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Home Program Using Multimodal Sensory Feedback for People With Parkinson Disease

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