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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04223245
Enrollment
26
Registered
2020-01-10
Start date
2017-06-29
Completion date
2019-03-08
Last updated
2020-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

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

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.

Interventions

BEHAVIORALexercise+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)

BEHAVIORALExercise 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.

Sponsors

Regis University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

blinded to subject group assignment

Intervention model description

Single blind randomized trial with 2 groups

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Changes in temporalspatial components of Gaitbaseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercisetemporal and spacial components of gait measured with Gaitrite Mat
changes in balancebaseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercisesingle leg stance time, time standing on foam eyes closed, Mini-BESTest
Change in cognitive attention needed for gaitBaseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise3 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 exerciseParkinson Disease Questionnaire (PDQ-39)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026