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Completed

NCT Number: NCT04223245

A Home Program Using Multimodal Sensory Feedback for 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regis University

Denver, Colorado, 80221, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercise+multi-modal sensory feedback (MMSF)

Behavioral

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)

Exercise only

Behavioral

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 outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Regis University

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 10, 2020
Registry last updated
Jan 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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