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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Behavioral: exercise+multi-modal sensory feedback (MMSF); Behavioral: Exercise only

• Registration Number: NCT04223245
• Lead Sponsor: Regis University

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.

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 Timeline

• Study Start: 2017-06-29
• Primary Completion: 2018-10-17
• Study Completion: 2019-03-08
• Study First Submitted: 2019-12-02
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-07
• Last Update Submitted: 2020-01-07
• Study First Posted: 2020-01-10
• Last Update Posted: 2020-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise+MMSF	exercise+multi-modal sensory feedback (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
exercise only	Exercise only	Group PWPD who did the same exercise program without MMSF

Primary Outcome Measures

Name	Time	Method
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
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
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)
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)

Trial Locations

Locations (1)

Regis University; 🇺🇸 Denver, Colorado, United States