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

NCT04223245 | Completed

• 1 other identifier: 1008713-3
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

multimodal; real-time feedback; automaticity; gait; balance

Outcome Measures

Primary Outcomes (4)

• Changes in temporalspatial components of Gait

  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

  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

  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,

  Parkinson Disease Questionnaire (PDQ-39)

  Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise

Study Arms (2)

exercise+MMSF

EXPERIMENTAL

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)

exercise only

ACTIVE COMPARATOR

Group PWPD who did the same exercise program without MMSF

Behavioral: Exercise only

Interventions

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+MMSF

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.

exercise only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regis University: lead

Study Sites (1)

Regis University

Denver, Colorado, 80221, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Patricia A Winkler, PT, DSc

  Regis University, 3333 Regis Blvd , Denver, Co 80221

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: blinded to subject group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind randomized trial with 2 groups

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: January 10, 2020
• Study Start: June 29, 2017
• Primary Completion: October 17, 2018
• Study Completion: March 8, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)