Balance Tele-Rehab in Parkinson's Disease

Official title

Balance Tele-rehabilitation With Wearable Technology for Older Adults With Parkinson's Disease

Overview

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.

Interventions

• Other Balance Tele-Rehabilitation Agility Boot Camp (ABC)
  The intervention is tele-rehabilitation conducted by a physical therapist virtually for 60 minutes approximately three times a week for four weeks (12 sessions). Participants will be assessed for seven days pre and post intervention using wearable sensors (APDM wearable technologies) to monitor daily mobility.

Primary outcome measures

• Change from Baseline in the Mini-BESTest, a 14-item test of 4 domains of balance post-rehabilitation [Time frame: Pre and Post rehabilitation]

Secondary outcome measures (12)

• Change from Baseline in the modified and standard Instrumented Stand and Walk (Modified ISAW and ISAW, respectively) tests post-rehabilitation [Time frame: Pre and Post rehabilitation]
• Change from Baseline in the Patient Global Impression of Change (PGIC), a seven point scale depicting the patient's impression of improvement post-rehabilitation [Time frame: after rehabilitation]
• Parkinson's Disease Questionaire-39 (PDQ-39) [Time frame: Pre and Post rehabilitation]
• MDS-United Parkinson's Disease Rating Scale (UPDRS) I-IV [Time frame: Pre and Post rehabilitation]
• N-Freezing of Gait Questionnaire (FoGQ) [Time frame: Pre and Post rehabilitation]
• International Physical Activity Questionnaire- Short Form (IPAQ) [Time frame: Pre and Post rehabilitation]
• Wearable Sensors to Measure Daily Life Mobility [Time frame: 8-10 hours per day for 7 days; Pre and Post rehabilitation]
• Activities-Specific Balance Confidence [Time frame: Pre and Post rehabilitation]
• Falls Efficacy Scale International [Time frame: Pre and Post rehabilitation]
• Self-Efficacy for Exercise Scale [Time frame: Pre and Post rehabilitation]
• Life Space Assessment Questionnaire [Time frame: Pre and Post rehabilitation]
• Time Up and Go Test [Time frame: Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).]

Eligibility criteria

Inclusion criteria

• 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
• responsive to levodopa (self-reported)
• Hoehn \& Yahr stages I-III;
• ages 55-85 years old
• ability to follow directions in order to participate in testing procedures and exercise classes
• free of any medical conditions or medication that contraindicates participation in an exercise program
• 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

• 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.)
• medical condition that precludes exercise
• 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
• recurrent fallers, defined as those who fall more than 3 times a week (from patient and caregiver recollection)
• excessive use of alcohol or recreational drugs
• recent change in medication
• inability to stand and walk for ISAW without an assistive device.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Oregon Health Science University — Portland

Publications

• 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. PMID 32249668
• 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. PMID 31927614
• 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. PMID 32417795
• 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. PMID 24955286
• 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. PMID 24379043
• 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. PMID 33101161
• 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. PMID 19228832
• 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. PMID 23738230

Identifiers

NCT: NCT05680597 · 1R01HD107074-01 · 1R01HD107074-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗