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

Parkinson Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04223245
• Other study ID #: 1008713-3
• Status: Completed
• Phase: N/A
• Start date: June 29, 2017
• Est. completion date: March 8, 2019

Study information

• Verified date: January 2020
• Source: Regis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 8, 2019
• Est. primary completion date: October 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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)
• 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.

Locations

Country	Name	City	State
United States	Regis University	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Regis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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