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CompletedNCT04223245Updated Jan 10, 2020

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

An interventional study of exercise+multi-modal sensory feedback (MMSF) and Exercise only in Parkinson Disease, sponsored by Regis University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-01-10.

Sponsored by Regis University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jun 2017, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
21 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • multimodal
  • real-time feedback
  • automaticity
  • gait
  • balance
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 26 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Regis University is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • 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)

  • Active comparator
    exercise only

    Group PWPD who did the same exercise program without MMSF

    Behavioral: Exercise only

Interventions

  • Behavioralexercise+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)

  • BehavioralExercise 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.

06

What researchers measure

Primary outcomes

  1. Changes in temporalspatial components of Gait

    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

  2. changes in balance

    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

  3. 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)

    Time frame: Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise

  4. Change in perceived difficulty during gait and ADLs,

    Parkinson Disease Questionnaire (PDQ-39)

    Time frame: Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise

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Study locations

1 site
  • Regis University
    Denver, Colorado 80221, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04223245
Lead sponsor
Regis University
Responsible party
Sponsor
First posted
Jan 10, 2020
Start date
Jun 29, 2017
Primary completion
Oct 17, 2018
Completion
Mar 8, 2019
Last update
Jan 10, 2020

Study contacts

Patricia A Winkler, PT, DSc
principal investigator · Regis University, 3333 Regis Blvd , Denver, Co 80221

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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