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NCT05680597 | RECRUITING | Parkinson Disease

Balance Tele-Rehab in Parkinson's Disease Parkinson's Disease
Sponsor:

Oregon Health and Science University

Information provided by (Responsible Party):

Laurie King

Brief Summary:

This project will determine the feasibility and efficacy of remote assessment and treatment of balance disorders in people with Parkinson's disease.

Condition or disease

Parkinson Disease

Intervention/treatment

Balance Tele-Rehabilitation Agility Boot Camp (ABC)

Phase

NA

Detailed Description:

This project consists of a virtual balance assessment which will use objective measures of balance and gait obtained with wearable sensors on the feet and waist. During a virtual assessment, the Modified Instrumented Stand and Walk Test (ISAW) will be conducted in 80 people with Parkinson's disease (PD) to predict a gold-standard, clinical in-person assessment of balance, the Mini-Balance Evaluation System Test (Mini-BESTest). For the balance rehabilitation there will be 80 participants randomized into two groups: 1) unsupervised home Agility Boot Camp (ABC) exercises (standard of care), 2) telerehabilitation with therapist conducting the ABC exercise program. Mobility during daily life will be measured using wearable sensors to explore if improvements after rehabilitation transfer to daily life mobility. The long-term goal of this project is to develop a more effective, home-based balance assessment and treatment that can be used in older adults with balance impairments to improve safe mobility during daily life.

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : SINGLE
Masking Description : Clinical pre- and post-testing will be carried out by a researcher who is blinded to group assignment. Scientists analyzing daily life monitoring data will also be blinded to pre-post status.
Primary Purpose : TREATMENT
Official Title : Balance Tele-rehabilitation With Wearable Technology for Older Adults With Parkinson's Disease
Actual Study Start Date : 2022-09-19
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 55 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia and one or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
  • 2. responsive to levodopa (self-reported)
  • 3. Hoehn \& Yahr stages I-III;
  • 4. ages 55-85 years old
  • 5. ability to follow directions in order to participate in testing procedures and exercise classes
  • 6. free of any medical conditions or medication that contraindicates participation in an exercise program
  • 7. willing and able to participate in rehabilitation intervention approximately 3x/week for 4 weeks while also refraining from making changes to medications (as reasonable) or to other exercise programs during the study period.
Exclusion Criteria
  • 1. Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and balance (i.e., musculoskeletal disorder, vestibular problem, head injury, stroke, cardiac disease, etc.)
  • 2. no medical condition that precludes exercise
  • 3. cognitive inability to participate in an exercise program, such as MoCA score less than or equal to 19, prior diagnosis of dementia or inability to follow directions
  • 4. recurrent fallers, defined as those who fall more than 3 times a week (from patient and caregiver recollection)
  • 5. excessive use of alcohol or recreational drugs
  • 6. recent change in medication
  • 7. inability to stand and walk for ISAW without an assistive device.
Balance Tele-Rehab in Parkinson's Disease Parkinson's Disease

Location Details

NCT05680597

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Locations

RECRUITING

United States, Oregon

Oregon Health Science University

Portland, Oregon, United States, 97239