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

January 7, 2020 updated by: Regis University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80221
        • Regis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: exercise+MMSF
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
Behavioral: exercise+multi-modal sensory feedback (MMSF)
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)
ACTIVE_COMPARATOR: exercise only
Group PWPD who did the same exercise program without MMSF
Behavioral: Exercise only
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in temporalspatial components of Gait
Time Frame: baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
temporal and spacial components of gait measured with Gaitrite Mat
baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
changes in balance
Time Frame: baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
single leg stance time, time standing on foam eyes closed, Mini-BESTest
baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
Change in cognitive attention needed for gait
Time Frame: Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
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)
Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
Change in perceived difficulty during gait and ADLs,
Time Frame: Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
Parkinson Disease Questionnaire (PDQ-39)
Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regis University

Investigators

  • Principal Investigator: Patricia A Winkler, PT, DSc, Regis University, 3333 Regis Blvd , Denver, Co 80221

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 29, 2017

Primary Completion (ACTUAL)

October 17, 2018

Study Completion (ACTUAL)

March 8, 2019

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

January 7, 2020

First Posted (ACTUAL)

January 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1008713-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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