Back to resultsBalance Tele-Rehab in Parkinson's Disease Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Balance Tele-Rehabilitation Agility Boot Camp (ABC)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Tele-rehabilitation, Balance, Mobility, Tele-assessment, Wearable-sensors
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.) no 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 multiple falls each day (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.
Sites / Locations
- Oregon Health Science UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Supervised Tele-Rehabilitation Home Exercise
Unsupervised Rehabilitation Home Exercise
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
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.
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.
International Physical Activity Questionnaire- Short Form (IPAQ)
This questionnaire asks about intensity and type of physical activity performed in the last 7 days
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.
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).
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).
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.
Life Space Assessment Questionnaire
This is a questionnaire where you will report on the area in which you live.
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.
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.
Floor Transfer Test
This timed test measures a participant's ability to sit down and rise from the floor.
360 Degree Turn Test
This test measures the time taken to turn 360 degrees to the left and right.
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.
Full Information
NCT ID
NCT05680597
First Posted
November 3, 2022
Last Updated
August 8, 2023
Sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT05680597
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Tele-rehabilitation, Balance, Mobility, Tele-assessment, Wearable-sensors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
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.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supervised Tele-Rehabilitation Home Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Unsupervised Rehabilitation Home Exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Balance Tele-Rehabilitation Agility Boot Camp (ABC)
Other Intervention Name(s)
Opal sensors; APDM Wearable Technologies
Intervention Description
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 Measure Information:
Title
Change from Baseline in the Mini-BESTest, a 14-item test of 4 domains of balance post-rehabilitation
Description
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.
Time Frame
Pre and Post rehabilitation
Secondary Outcome Measure Information:
Title
Change from Baseline in the modified and standard Instrumented Stand and Walk (Modified ISAW and ISAW, respectively) tests post-rehabilitation
Description
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.
Time Frame
Pre and Post rehabilitation
Title
Change from Baseline in the Patient Global Impression of Change (PGIC), a seven point scale depicting the patient's impression of improvement post-rehabilitation
Description
The PGIC is one question rated on a seven point Likert scale measuring impression of change after intervention.
Time Frame
after rehabilitation
Title
Parkinson's Disease Questionaire-39 (PDQ-39)
Description
This is a questionnaire looking at how Parkinson's Disease has affected quality of life over the last month
Time Frame
Pre and Post rehabilitation
Title
MDS-United Parkinson's Disease Rating Scale (UPDRS) I-IV
Description
This is a questionnaire evaluating various aspects of Parkinson's disease, including motor and non-motor symptoms and activities of daily living.
Time Frame
Pre and Post rehabilitation
Title
Freezing of Gait Questionnaire (FoGQ)
Description
This is a questionnaire asking about different situations that cause freezing of gait and how it may affect your balance.
Time Frame
Pre and Post rehabilitation
Title
International Physical Activity Questionnaire- Short Form (IPAQ)
Description
This questionnaire asks about intensity and type of physical activity performed in the last 7 days
Time Frame
Pre and Post rehabilitation
Title
Wearable Sensors to Measure Daily Life Mobility
Description
Use instrumented socks and a sensor (manufacturer: APDM) around the waist to measure gait quality, such as turn speed, over seven days of monitoring.
Time Frame
8-10 hours per day for 7 days; Pre and Post rehabilitation
Title
Activities-Specific Balance Confidence
Description
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).
Time Frame
Pre and Post rehabilitation
Title
Falls Efficacy Scale International
Description
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).
Time Frame
Pre and Post rehabilitation
Title
Self-Efficacy for Exercise Scale
Description
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.
Time Frame
Pre and Post rehabilitation
Title
Life Space Assessment Questionnaire
Description
This is a questionnaire where you will report on the area in which you live.
Time Frame
Pre and Post rehabilitation
Title
Time Up and Go Test
Description
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.
Time Frame
Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
Title
TabCAT
Description
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.
Time Frame
Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
Title
Floor Transfer Test
Description
This timed test measures a participant's ability to sit down and rise from the floor.
Time Frame
Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
Title
360 Degree Turn Test
Description
This test measures the time taken to turn 360 degrees to the left and right.
Time Frame
Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
Title
Five-Time Sit-to-Stand Test
Description
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.
Time Frame
Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.)
no 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 multiple falls each day (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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie King, PhD
Phone
503-418-2602
Email
kingla@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Mancini, PhD
Phone
503-418-2600
Email
mancinim@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie A King, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie King
Email
kingla@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Ruby Larisch
Email
Larisch@ohsu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
32249668
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.
Results Reference
background
PubMed Identifier
31927614
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.
Results Reference
background
PubMed Identifier
32417795
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.
Results Reference
background
PubMed Identifier
24955286
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.
Results Reference
background
PubMed Identifier
24379043
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.
Results Reference
background
PubMed Identifier
33101161
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.
Results Reference
background
PubMed Identifier
19228832
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.
Results Reference
background
PubMed Identifier
23738230
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.
Results Reference
background
PubMed Identifier
26308937
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.
Results Reference
background
PubMed Identifier
19329772
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.
Results Reference
background
PubMed Identifier
21934364
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.
Results Reference
background
PubMed Identifier
30153767
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. Erratum In: J Telemed Telecare. 2020 Jan-Feb;26(1-2):119.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://octri.ohsu.edu/redcap/redcap_v12.5.12/DataEntry/index.php?pid=3056&id=EI254&event_id=105878&page=demographics
Available IPD/Information Comments
Data will be gathered from questionnaires and instrumented assessments, and entered into the web-based Research Electronic Data Capture system (REDCap) and into the OHSU Balance Disorders database. REDCap is a secure electronic database administered by OHSU. Hard copies of these records will be stored behind a locked office in a locked cabinet at OHSU. The de-identified Mobility Lab data will be collected on a password-protected and data-encrypted laptop computer and uploaded after each test session to an OHSU secure server, where the Balance Disorders database is located.
Learn more about this trial
Balance Tele-Rehab in Parkinson's Disease Parkinson's Disease
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