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

Sponsor
Regis University (Other)
Overall Status
Completed
CT.gov ID
NCT04223245
Collaborator
(none)
26
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2
20.3
1.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: exercise+multi-modal sensory feedback (MMSF)
  • Behavioral: Exercise only
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single blind randomized trial with 2 groupsSingle blind randomized trial with 2 groups
Masking:
Single (Outcomes Assessor)
Masking Description:
blinded to subject group assignment
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jun 29, 2017
Actual Primary Completion Date :
Oct 17, 2018
Actual Study Completion Date :
Mar 8, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Changes in temporalspatial components of Gait [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 [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 [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, [Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise]

    Parkinson Disease Questionnaire (PDQ-39)

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regis University Denver Colorado United States 80221

Sponsors and Collaborators

  • Regis University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regis University
ClinicalTrials.gov Identifier:
NCT04223245
Other Study ID Numbers:
  • 1008713-3
First Posted:
Jan 10, 2020
Last Update Posted:
Jan 10, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Regis University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2020