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Smartphone-based Wearable Telerehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146454
Recruitment Status : Enrolling by invitation
First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Houston

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Smartphone-based balance exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Study participants will be assigned to either of two groups (intervention group and control group)
Masking: Single (Investigator)
Masking Description: Potential participants diagnosed with Parkinson's disease will be randomly assigned to either of two groups (intervention group and control group).
Primary Purpose: Treatment
Official Title: A New Smartphone-based Wearable Telerehabilitation System for People With Parkinson's Disease
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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).

No Intervention: Paper-based balance exercises
This group will complete in-home dynamic weight-shifting balance exercises (i.e., physical therapists' recommended dynamic balance exercises) with typical paper-based instructions.



Primary Outcome Measures :
  1. Range of limits of stability; change is being assessed [ Time Frame: Pre-assessment (baseline at the beginning of week 1) ]
    Limit of stability refers to the outermost range in anterior-posterior and medial-lateral directions at which the subject can lean from the vertical without changing the base of support. A higher range of limits of stability indicates better balance performance.

  2. Sensory Organization Test (SOT) score; change is being assessed [ Time Frame: Pre-assessment (baseline at the beginning of week 1) ]
    Sensory Organization Test (SOT) score ranges from 0 to 100, where 100 indicates no postural sway and 0 indicates a fall.

  3. Root mean square (RMS) of postural sway; change is being assessed [ Time Frame: Pre-assessment (baseline at the beginning of week 1) ]
    Root mean square (RMS) of postural sway is the primary measure of postural sway. A lower value of root mean square (RMS) of postural sway indicates more stable balance.

  4. Elliptical area of postural sway; change is being assessed [ Time Frame: Pre-assessment (baseline at the beginning of week 1) ]
    Elliptical area of postural sway is the area of postural sway. Smaller sway area indicates better balance performance.

  5. Approximate entropy of postural sway; change is being assessed [ Time Frame: Pre-assessment (baseline at the beginning of week 1) ]
    Approximate entropy of postural sway refers to the complexity and regularity of postural sway. It ranges from 0 to 2, where 0 indicates regular postural sway and 2 indicates complexity postural sway.


Secondary Outcome Measures :
  1. Activities-specific Balance Confidence (ABC) scale [ Time Frame: Pre-assessment (baseline at the beginning of week 1), post-assessment (at the end of week 6), and retention-assessment (1 month after week 6) ]
    The Activities-specific Balance Confidence (ABC) scale is a 16-item self-reported measure used by subjects to rate their balance confidence in performing activities. The minimum and maximum scores are 0 and 100; a score of zero represents no confidence in balance, and a score of 100 represents complete confidence in balance.

  2. Fall Efficacy Scale (FES) [ Time Frame: Pre-assessment (baseline at the beginning of week 1), post-assessment (at the end of week 6), and retention-assessment (1 month after week 6) ]
    The Fall Efficacy Scale (FES) is a self-reported questionnaire consisting of a 10 item rating scale used by subjects to rate their balance confidence in performing daily activities without falling. The Fall Efficacy Scale (FES) has a scale from 1 to 10, with 1 being very confident in performing daily activities without falling and 10 being not confident at all in performing daily activities without falling.

  3. Community Health Activities Model Program for Seniors (CHAMPS) [ Time Frame: Pre-assessment (baseline at the beginning of week 1), post-assessment (at the end of week 6), and retention-assessment (1 month after week 6) ]
    The Community Health Activities Model Program for Seniors (CHAMPS) is a self-reported physical activity questionnaire. The minimum and maximum scores are 0 and 41; a higher score indicates better physical activity.


Other Outcome Measures:
  1. Usability and acceptability questionnaire (UAQ) [ Time Frame: Post-assessment (at the end of week 6) ]
    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 scale from 24 to 120, with 120 being very confident in using the system and 24 being not confident at all in using the system.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Inability to provide informed consent.
  2. Cognitive score less than 26 as determined by the Montreal Cognitive Assessment.
  3. Are not ready for physical activity as determined by the modified Physical Activity Readiness Questionnaire.
  4. Have dyskinesia.
  5. Unable to stand independently for 10 minutes due to dyskinesia.
  6. Have severe distal sensory loss.
  7. Are medically unstable (chest pain upon exertion, dyspnea, or epilepsy).
  8. Have any peripheral, neurological, or musculoskeletal conditions other than PD.

    1. History of peripheral sensory disease that might affect balance stability (e.g., peripheral neuropathy, Type 2 diabetes, vestibular disorder, etc.).
    2. History of central neurologic dysfunction such as stroke or myelopathy.
    3. 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.).
  9. Body mass index (BMI) over 35 computed from individual's height and weight.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146454


Locations
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United States, Texas
Center for Neuromotor and Biomechanics Research
Houston, Texas, United States, 77204
Sponsors and Collaborators
University of Houston
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Beom Chan Lee, PhD University of Houston
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Responsible Party: University of Houston
ClinicalTrials.gov Identifier: NCT04146454    
Other Study ID Numbers: 16191-01
1R21HD099242 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All of the materials collected are for research purposes only, and all data will be kept in strict confidence. No information will be given to anyone without permission from the subject. The consent form includes the informed consent statement required by University of Houston IRB for studies involving human subjects. This statement guarantees confidentiality and identifies the subject as the owner of information we collected from this study. Confidentiality will be ensured by use of identification codes. All data, whether generated in the laboratory or at the subject's home, will be identified with an identification code unique to the subject.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Houston:
Parkinson's disease
In-home balance training
Smartphone-based wearable telerehabilitation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases