N/A
N=9
Smartphone-based Wearable Telerehabilitation
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT04146454 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Usability and Acceptability Questionnaire (UAQ) — 4.86 Score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Smartphone-based balance exercises (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Houston
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usability and Acceptability Questionnaire (UAQ) |
4.86 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04146454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.