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NCT04146454 · ClinicalTrials.gov registry record

Smartphone-based Wearable Telerehabilitation

A clinical trial, sponsored by University of Houston.

Completed
Registry status
9
Enrollment target

NCT04146454: Completed study, sponsored by University of Houston.

NCT04146454 is a clinical trial that has completed, run by University of Houston. The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04146454 has completed, sponsored by University of Houston.

COMPLETED
Registry status
9 participants
Enrollment target

Study Summary

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 co

Primary Outcome

The Usability and acceptability questionnaire (UAQ) is a self-reported questionnaire used by subjects to assess the usability and acceptability of the proposed smartphone-based wearable telerehabilitation system. The Usability and acceptability questionnaire (UAQ) has a comparative Likert scale survey (strongly disagree (1), disagree (2), neither disagree nor agree (3), agree (4), or strongly agree (5)), with 5 being very confident in using the system and 1 being not confident at all in using th

Interventions

  • OTHER Smartphone-based balance exercises

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2019-10-14
Est. Completion 2021-10-31
University of Houston

64 total trials

What the finished NCT04146454 record still lists

NCT04146454 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 9 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Smartphone-based balance exercises is the first listed.

NCT04146454 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04146454 about?

NCT04146454 is a clinical study titled "Smartphone-based Wearable Telerehabilitation". 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 ...

What is the current status of trial NCT04146454?

This trial is currently completed. The enrollment target is 9 participants. The study started on 2019-10-14. Estimated completion is 2021-10-31.

What interventions are being tested in trial NCT04146454?

The interventions under investigation include: Smartphone-based balance exercises (OTHER).

Who is sponsoring clinical trial NCT04146454?

This trial is sponsored by University of Houston, which has 64 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04146454, the US trial registry maintained by the National Library of Medicine. NCT04146454 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.