NCT04146454

Smartphone-based Wearable Telerehabilitation

Status unknown NA Last updated 31 October 2019

What this trial tests

NA trial testing Smartphone-based balance exercises in Parkinson Disease in 44 participants. Status unknown.

Timeline

14 October 2019

Primary endpoint
31 May 2021

31 July 2021

Quick facts

Lead sponsor	University of Houston
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	44
Start date	14 October 2019
Primary completion	31 May 2021
Estimated completion	31 July 2021
Sites	1 location across United States

Drugs / interventions tested

• Smartphone-based balance exercises

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

University of Houston

Who can join

Adults 50 to 75, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Parkinson's disease (PD), one of the most common neurological disorders, affects at least 10 million people worldwide. The cardinal motor impairments are tremor, bradykinesia, muscle rigidity, and postural instability. While dopaminergic medication and surgical treatment have been shown to suppress tremor, bradykinesia, and muscle rigidity, they do not prevent the progression of the disease or effectively treat postural instability. The latter impairment, which often leads to frequent falls, substantially restricts motor performance and daily activities.

PD is commonly managed in outpatient neurology or movement disorder clinics. Clinical studies have shown that physical and balance rehabilitation regimens supervised by physical therapists can improve postural stability in people with PD for short (hours to days) and long (weeks to months) periods. Cost, limited availability of physical therapists, etc., however, often prohibit many people with PD from undertaking such regimens. Evidence is mounting that periodic and continuous exercising is important for people with PD who are under care at home. Nevertheless, when given a rehabilitation regimen to practice at home, compliance (i.e., adherence) and engagement generally decrease in the absence of real-time therapeutic feedback. The PI has developed a smartphone-based, wearable balance rehabilitation system, known as the Smarter Balance System (SBS), which supplies real-time feedback to people with PD practicing balance rehabilitation regimens at home.

The objectives of this study are to assess and compare the results of long-term rehabilitative balance training for people with PD performing in-home balance training regimens with assistive guidance via the SBS (intervention group) to people following a typical paper-based regimen (control group). The carry-over effects of long-term rehabilitative training by the intervention group and the control group on static/dynamic balance performance, daily activities, and confidence in less fear of falling are analyzed quantitatively and qualitatively.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Performing Dynamic Weight-Shifting Balance Exercises With a Smartphone-Based Wearable Telerehabilitation System for Home Use by Individuals With Parkinson's Disease: A Proof-of-Concept Study.
   Lee BC, An J, Kim J, Lai EC. · · 2023 · cited 12× · PMID 36455080 · DOI 10.1109/tnsre.2022.3226368