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Parkinson DiseaseNCT05680597

Balance Tele-Rehab in Parkinson's Disease

A study testing Balance Tele-Rehabilitation Agility Boot Camp (ABC) in people with Parkinson Disease, run by Oregon Health and Science University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Parkinson Disease
What is being tested?
Balance Tele-Rehabilitation Agility Boot Camp (ABC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
19 Sep 2022to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Laurie King, PhD contact

503-418-2602

kingla@ohsu.edu

Martina Mancini, PhD contact

503-418-2600

mancinim@ohsu.edu

United States1 site, 1 recruiting
  • Oregon Health Science University

    Portland, Oregon, 97239

    Laurie King, kingla@ohsu.edu

    Patty Carlson-Kuhta, PhD, carlsonp@ohsu.edu

    Recruiting

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Balance Tele-Rehabilitation Agility Boot Camp (ABC)
Keywords
Tele-rehabilitation, Balance, Mobility, Tele-assessment, Wearable-sensors
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Opal sensors; APDM Wearable Technologies

    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.

Study groups in NCT05680597
Study groupRoleWhat they receive
Supervised Tele-Rehabilitation Home ExerciseExperimental40 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.
Receives: Other: Balance Tele-Rehabilitation Agility Boot Camp (ABC)
Unsupervised Rehabilitation Home ExerciseActive comparator40 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.
Receives: Other: Balance Tele-Rehabilitation Agility Boot Camp (ABC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Pre and Post rehabilitation

Secondary outcomes (16)
  1. Change from Baseline in the modified and standard Instrumented Stand and Walk (Modified ISAW and ISAW, respectively) tests post-rehabilitation

    For the ISAW, the participant will don 3 sensors and be instructed to stand for 30 seconds, walk 12 steps, turn around, and walk back. The ISAW has the ability to characterize multiple domains of balance, similar to the Mini-BESTest, including postural sway in standing with feet together with eyes open for 30 seconds prior to step initiation and gait with a 180-degree turn. During the Modified ISAW, the participant will don 3 sensors and be instructed to stand for 30 seconds, walk at least 10 steps, turn 90 degrees and complete an L-shaped path, then turn 180 degrees and retrace the L-shaped path.

    Measured: Pre and Post rehabilitation

  2. Change from Baseline in the Patient Global Impression of Change (PGIC), a seven point scale depicting the patient's impression of improvement post-rehabilitation

    The PGIC is one question rated on a seven point Likert scale measuring impression of change after intervention.

    Measured: after rehabilitation

  3. Parkinson's Disease Questionaire-39 (PDQ-39)

    This is a questionnaire looking at how Parkinson's Disease has affected quality of life over the last month

    Measured: Pre and Post rehabilitation

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

    This is a questionnaire evaluating various aspects of Parkinson's disease, including motor and non-motor symptoms and activities of daily living.

    Measured: Pre and Post rehabilitation

  5. N-Freezing of Gait Questionnaire (FoGQ)

    This is a questionnaire asking about different situations that cause freezing of gait and how it may affect your balance.

    Measured: Pre and Post rehabilitation

  6. International Physical Activity Questionnaire- Short Form (IPAQ)

    This questionnaire asks about intensity and type of physical activity performed in the last 7 days

    Measured: Pre and Post rehabilitation

  7. Wearable Sensors to Measure Daily Life Mobility

    Use instrumented socks and a sensor (manufacturer: APDM) around the waist to measure gait quality, such as turn speed, over seven days of monitoring.

    Measured: 8-10 hours per day for 7 days; Pre and Post rehabilitation

  8. Activities-Specific Balance Confidence

    This is a questionnaire that measures confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It consists of 16 questions and is scored from 0-100 (0 is no confidence and 100 is full confidence).

    Measured: Pre and Post rehabilitation

  9. Falls Efficacy Scale International

    This is a test that measures level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity. It is a 16-item questionnaire, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).

    Measured: Pre and Post rehabilitation

  10. Self-Efficacy for Exercise Scale

    This is a questionnaire looking at beliefs in ability to continue exercising on a three-time-a-week basis at moderate intensities. It consists of 8 questions and is scored 0-100% per question where 0 is not at all confident and 100 is highly confident.

    Measured: Pre and Post rehabilitation

  11. Life Space Assessment Questionnaire

    This is a questionnaire where you will report on the area in which you live.

    Measured: Pre and Post rehabilitation

  12. Time Up and Go Test

    This test measures the time taken to rise from a seated position, walk 3 meters at a comfortable pace, turn on the spot, return to the starting point, and sit back down.

    Measured: Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).

  13. TabCAT

    Participants will use an iPad to complete tests looking at different aspects of cognitive function: 1) Benton Judgement of Line Orientation (JLO) will be used to assess visuospatial and executive function. 2) The Flanker test will be used to assess cognitive control and inhibition. 3) The Set Shifting test will be used to assess cognitive flexibility. These tests are components of the TabCAT test battery.

    Measured: Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).

  14. Floor Transfer Test

    This timed test measures a participant's ability to sit down and rise from the floor.

    Measured: Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).

  15. 360 Degree Turn Test

    This test measures the time taken to turn 360 degrees to the left and right.

    Measured: Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).

  16. Five-Time Sit-to-Stand Test

    This test measures functional mobility and lower-body strength. Participants will be timed as they rise five times from sitting (standard chair height) to standing.

    Measured: Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2023
  2. Study start19 Sep 2022
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05680597
Sponsor's protocol ID
1R01HD107074-01
Other IDs
1R01HD107074-01A1
Status last verified
May 2026
First submitted
3 Nov 2022
Last updated
22 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 23738230
  • 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.

    PubMed 26308937
  • 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.

    PubMed 19329772
  • 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.

    PubMed 21934364
  • 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.

    PubMed 30153767
  • 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.

    PubMed 37833645

Questions about this trial

What is this clinical trial studying?

A study testing Balance Tele-Rehabilitation Agility Boot Camp (ABC) in people with Parkinson Disease, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laurie King, PhD (503-418-2602, kingla@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the Mini-BESTest, a 14-item test of 4 domains of balance post-rehabilitation (time frame: Pre and Post rehabilitation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05680597, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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