NCT05680597

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
12mo left

Started Sep 2022

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Sep 2022Jun 2027

Study Start

First participant enrolled

September 19, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

4.7 years

First QC Date

November 3, 2022

Last Update Submit

May 19, 2026

Conditions

Parkinson Disease

Keywords

Tele-rehabilitationBalanceMobilityTele-assessmentWearable-sensors

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in the Mini-BESTest, a 14-item test of 4 domains of balance post-rehabilitation

    The Mini-BESTest, a 14-item test of 4 domains of balance, that has been well studied and is related to fall risk in people with Parkinson's disease.

    Pre and Post rehabilitation

Secondary Outcomes (16)

  • Change from Baseline in the modified and standard Instrumented Stand and Walk (Modified ISAW and ISAW, respectively) tests post-rehabilitation

    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

    after rehabilitation

  • Parkinson's Disease Questionaire-39 (PDQ-39)

    Pre and Post rehabilitation

  • MDS-United Parkinson's Disease Rating Scale (UPDRS) I-IV

    Pre and Post rehabilitation

  • N-Freezing of Gait Questionnaire (FoGQ)

    Pre and Post rehabilitation

  • +11 more secondary outcomes

Study Arms (2)

Supervised Tele-Rehabilitation Home Exercise

EXPERIMENTAL

40 participants will have tele-rehabilitation virtually with a physical therapist for 60 minutes approximately three times per week for four weeks of intervention (12 visits). Participants will also be assessed for daily life mobility for seven days pre and post intervention with wearable sensors.

Other: Balance Tele-Rehabilitation Agility Boot Camp (ABC)

Unsupervised Rehabilitation Home Exercise

ACTIVE COMPARATOR

40 participants will complete their home exercise Agility Boot Camp (ABC) program for 60 minutes approximately three times per week for four weeks of intervention (12 sessions). Participants will also be assessed for daily life mobility for seven days pre and post intervention with wearable sensors.

Other: Balance Tele-Rehabilitation Agility Boot Camp (ABC)

Interventions

Balance Tele-Rehabilitation Agility Boot Camp (ABC)OTHER

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.

Also known as: Opal sensors; APDM Wearable Technologies
Supervised Tele-Rehabilitation Home ExerciseUnsupervised Rehabilitation Home Exercise

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health Science University

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (13)

  • 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: 32249668BACKGROUND

  • 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: 31927614BACKGROUND

  • 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: 32417795BACKGROUND

  • 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: 24955286BACKGROUND

  • 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: 24379043BACKGROUND

  • 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: 33101161BACKGROUND

  • 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: 19228832BACKGROUND

  • 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: 23738230BACKGROUND

  • 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.

    PMID: 26308937BACKGROUND

  • 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.

    PMID: 19329772BACKGROUND

  • 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.

    PMID: 21934364BACKGROUND

  • 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.

    PMID: 30153767BACKGROUND

  • Silva-Batista C, Wilhelm JL, Scanlan KT, Stojak M, Carlson-Kuhta P, Chen S, Liu W, de la Huerta TNG, Horak FB, Mancini M, King LA. Balance telerehabilitation and wearable technology for people with Parkinson's disease (TelePD trial). BMC Neurol. 2023 Oct 13;23(1):368. doi: 10.1186/s12883-023-03403-3.

    PMID: 37833645DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Laurie A King, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie King, PhD

CONTACT

503-418-2602kingla@ohsu.edu

Martina Mancini, PhD

CONTACT

503-418-2600mancinim@ohsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2022

First Posted

January 11, 2023

Study Start

September 19, 2022

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

This study does not propose to collect or store human specimens. Data will be coded with a unique subject identification (ID) that the primary investigator (PI) and research assistant (RA) will be able to link the ID to the person. Subject information and study data will be stored behind a locked office in a locked cabinet at OHSU (if paper) or behind a secure Oregon Health \& Science University (OHSU) firewall on network drives requiring password authentication (if electronic). Data will be stored at OHSU in our secure database and may be used for future research. We will also ask permission from our subjects to be maintain their data in our Balance Disorders Laboratory repository (eIRB# 7797). If a subject does not want their data included in the repository, this information will be flagged in REDCap. After data collection and analysis is completed, we will de-identify the data and retain only until post-publication and then their data will be deleted.

Available IPD Datasets

Study Protocol Access

Locations

US(1)