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

NCT ID: NCT04223245

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-29
• Study Completion Date: 2019-03-08

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

exercise+multi-modal sensory feedback (MMSF)

Intervention Type: 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 only

Group PWPD who did the same exercise program without MMSF

Group Type: ACTIVE_COMPARATOR

Exercise only

Intervention Type: 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.

Interventions

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)

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regis University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia A Winkler, PT, DSc

Role: PRINCIPAL_INVESTIGATOR

Regis University, 3333 Regis Blvd , Denver, Co 80221

Locations

Regis University

Denver, Colorado, United States

Countries

United States

Other Identifiers

1008713-3

Identifier Type: -

Identifier Source: org_study_id