Smartphone-based Wearable Telerehabilitation

NCT04146454 | Completed Results

• 2 other identifiers: 16191-011R21HD099242
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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 confidence in less fear of falling are analyzed quantitatively and qualitatively.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; In-home balance training; Smartphone-based wearable telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Usability and Acceptability Questionnaire (UAQ)

  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 the system.

  Post-assessment (at the end of week 6)

Study Arms (1)

Smartphone-based balance exercises

This group will complete in-home dynamic weight-shifting balance exercises (i.e., physical therapists' recommended dynamic balance exercises) with a smartphone-based wearable telerehabilitation system.

Other: Smartphone-based balance exercises

Interventions

Smartphone-based balance exercises OTHER

A smartphone-based wearable telerehabilitation system will provide video and audio instructions on how to perform in-home dynamic weight-shifting balance exercises (i.e., physical therapists' recommended dynamic balance exercises).

Smartphone-based balance exercises

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is individuals diagnosed with Parkinson's disease (PD).

You may qualify if:

• Age between 50 and 75 years.
• Diagnosis of idiopathic PD with a score of 2 and 4 on the Hoehn and Yahr scale.
• Live with family members or have caregivers.
• Able to provide informed consent.

You may not qualify if:

• Inability to provide informed consent.
• Cognitive score less than 26 as determined by the Montreal Cognitive Assessment.
• Are not ready for physical activity as determined by the modified Physical Activity Readiness Questionnaire.
• Have dyskinesia.
• Unable to stand independently for 10 minutes due to dyskinesia.
• Have severe distal sensory loss.
• Are medically unstable (chest pain upon exertion, dyspnea, or epilepsy).
• Have any peripheral, neurological, or musculoskeletal conditions other than PD.
• History of peripheral sensory disease that might affect balance stability (e.g., peripheral neuropathy, Type 2 diabetes, vestibular disorder, etc.).
• History of central neurologic dysfunction such as stroke or myelopathy.
• History of functionally significant musculoskeletal dysfunction (e.g., lower extremity total joint replacement in the past six months, lower extremity fracture/sprain in the past six months, limited ankle range of motion (ankle dorsiflexor/plantar flexor weakness or great toe weakness), etc.).
• Body mass index (BMI) over 35 computed from individual's height and weight.

Sponsors & Collaborators

• University of Houston: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Center for Neuromotor and Biomechanics Research

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Beom Chan Lee
• Organization: University of Houston

blee24@central.uh.edu

713-743-6369

Study Officials

• Beom Chan Lee, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 31, 2019
• Study Start: October 14, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: May 20, 2026
• Results First Posted: May 20, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)