Clinical trial NCT04223245: A Home Program Using Multimodal Sensory Feedback for People With Parkinson Disease
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: multimodal
real-time feedback
automaticity
gait
balance
Lead sponsor: Regis University
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind randomized trial with 2 groups
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in temporalspatial components of Gait
timeFrame: baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
measure: changes in balance
timeFrame: baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
measure: Change in cognitive attention needed for gait
timeFrame: Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
measure: Change in perceived difficulty during gait and ADLs,
timeFrame: Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Regis University
state: Colorado
Study officials:
affiliation: Regis University, 3333 Regis Blvd , Denver, Co 80221
name: Patricia A Winkler, PT, DSc
role: PRINCIPAL_INVESTIGATOR
References: