Clinical trial NCT05680597: Balance Tele-Rehab in Parkinson's Disease Parkinson's Disease
Official title: Balance Tele-rehabilitation With Wearable Technology for Older Adults With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Tele-rehabilitation
Balance
Mobility
Tele-assessment
Wearable-sensors
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-01-11
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will randomize the 80 participants into two groups: 1) unsupervised home Agility Boot Camp (ABC) exercises (standard of care), 2) supervised balance (ABC) with therapist tele-rehabilitation.
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Change from Baseline in the Mini-BESTest, a 14-item test of 4 domains of balance post-rehabilitation
timeFrame: Pre and Post rehabilitation
Secondary outcomes:
measure: Change from Baseline in the modified and standard Instrumented Stand and Walk (Modified ISAW and ISAW, respectively) tests post-rehabilitation
timeFrame: Pre and Post rehabilitation
measure: Change from Baseline in the Patient Global Impression of Change (PGIC), a seven point scale depicting the patient's impression of improvement post-rehabilitation
timeFrame: after rehabilitation
measure: Parkinson's Disease Questionaire-39 (PDQ-39)
timeFrame: Pre and Post rehabilitation
measure: MDS-United Parkinson's Disease Rating Scale (UPDRS) I-IV
timeFrame: Pre and Post rehabilitation
measure: Freezing of Gait Questionnaire (FoGQ)
timeFrame: Pre and Post rehabilitation
measure: International Physical Activity Questionnaire- Short Form (IPAQ)
timeFrame: Pre and Post rehabilitation
measure: Wearable Sensors to Measure Daily Life Mobility
timeFrame: 8-10 hours per day for 7 days; Pre and Post rehabilitation
measure: Activities-Specific Balance Confidence
timeFrame: Pre and Post rehabilitation
measure: Falls Efficacy Scale International
timeFrame: Pre and Post rehabilitation
measure: Self-Efficacy for Exercise Scale
timeFrame: Pre and Post rehabilitation
measure: Life Space Assessment Questionnaire
timeFrame: Pre and Post rehabilitation
measure: Time Up and Go Test
timeFrame: Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
measure: TabCAT
timeFrame: Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
measure: Floor Transfer Test
timeFrame: Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
measure: 360 Degree Turn Test
timeFrame: Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
measure: Five-Time Sit-to-Stand Test
timeFrame: Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Laurie A King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: King LA, Mancini M, Smulders K, Harker G, Lapidus JA, Ramsey K, Carlson-Kuhta P, Fling BW, Nutt JG, Peterson DS, Horak FB. Cognitively Challenging Agility Boot Camp Program for Freezing of Gait in Parkinson Disease. Neurorehabil Neural Repair. 2020 May;34(5):417-427. doi: 10.1177/1545968320909331. Epub 2020 Apr 4.
citation: Shah VV, McNames J, Mancini M, Carlson-Kuhta P, Spain RI, Nutt JG, El-Gohary M, Curtze C, Horak FB. Quantity and quality of gait and turning in people with multiple sclerosis, Parkinson's disease and matched controls during daily living. J Neurol. 2020 Apr;267(4):1188-1196. doi: 10.1007/s00415-020-09696-5. Epub 2020 Jan 11.
citation: Shah VV, McNames J, Mancini M, Carlson-Kuhta P, Nutt JG, El-Gohary M, Lapidus JA, Horak FB, Curtze C. Digital Biomarkers of Mobility in Parkinson's Disease During Daily Living. J Parkinsons Dis. 2020;10(3):1099-1111. doi: 10.3233/JPD-201914.
citation: Mancini M, King L, Salarian A, Holmstrom L, McNames J, Horak FB. Mobility Lab to Assess Balance and Gait with Synchronized Body-worn Sensors. J Bioeng Biomed Sci. 2011 Dec 12;Suppl 1:007. doi: 10.4172/2155-9538.S1-007.
citation: El-Gohary M, Pearson S, McNames J, Mancini M, Horak F, Mellone S, Chiari L. Continuous monitoring of turning in patients with movement disability. Sensors (Basel). 2013 Dec 27;14(1):356-69. doi: 10.3390/s140100356.
citation: Hasegawa N, Shah VV, Harker G, Carlson-Kuhta P, Nutt JG, Lapidus JA, Jung SH, Barlow N, King LA, Horak FB, Mancini M. Responsiveness of Objective vs. Clinical Balance Domain Outcomes for Exercise Intervention in Parkinson's Disease. Front Neurol. 2020 Sep 25;11:940. doi: 10.3389/fneur.2020.00940. eCollection 2020.
citation: King LA, Horak FB. Delaying mobility disability in people with Parkinson disease using a sensorimotor agility exercise program. Phys Ther. 2009 Apr;89(4):384-93. doi: 10.2522/ptj.20080214. Epub 2009 Feb 19.
citation: King LA, Salarian A, Mancini M, Priest KC, Nutt J, Serdar A, Wilhelm J, Schlimgen J, Smith M, Horak FB. Exploring outcome measures for exercise intervention in people with Parkinson's disease. Parkinsons Dis. 2013;2013:572134. doi: 10.1155/2013/572134. Epub 2013 Apr 30.
citation: King LA, Wilhelm J, Chen Y, Blehm R, Nutt J, Chen Z, Serdar A, Horak FB. Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial. J Neurol Phys Ther. 2015 Oct;39(4):204-12. doi: 10.1097/NPT.0000000000000101.
citation: Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009 May;89(5):484-98. doi: 10.2522/ptj.20080071. Epub 2009 Mar 27.
citation: Leddy AL, Crowner BE, Earhart GM. Utility of the Mini-BESTest, BESTest, and BESTest sections for balance assessments in individuals with Parkinson disease. J Neurol Phys Ther. 2011 Jun;35(2):90-7. doi: 10.1097/NPT.0b013e31821a620c.
citation: Chen YY, Guan BS, Li ZK, Yang QH, Xu TJ, Li HB, Wu QY. Application of telehealth intervention in Parkinson's disease: A systematic review and meta-analysis. J Telemed Telecare. 2020 Jan-Feb;26(1-2):3-13. doi: 10.1177/1357633X18792805. Epub 2018 Aug 28.