Balance Tele-Rehab in Parkinson's Disease Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05680597
• Other study ID #: 1R01HD107074-01
• Secondary ID: 1R01HD107074-01A
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: June 2027

Study information

• Verified date: July 2023
• Source: Oregon Health and Science University
• Contact: Laurie King, PhD
• Phone: 503-418-2602
• Email: kingla[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Pre and Post rehabilitation
Secondary	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.	after rehabilitation
Secondary	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	Pre and Post rehabilitation
Secondary	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.	Pre and Post rehabilitation
Secondary	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.	Pre and Post rehabilitation
Secondary	International Physical Activity Questionnaire- Short Form (IPAQ)	This questionnaire asks about intensity and type of physical activity performed in the last 7 days	Pre and Post rehabilitation
Secondary	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.	8-10 hours per day for 7 days; Pre and Post rehabilitation
Secondary	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).	Pre and Post rehabilitation
Secondary	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).	Pre and Post rehabilitation
Secondary	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.	Pre and Post rehabilitation
Secondary	Life Space Assessment Questionnaire	This is a questionnaire where you will report on the area in which you live.	Pre and Post rehabilitation
Secondary	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.	Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
Secondary	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.	Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
Secondary	Floor Transfer Test	This timed test measures a participant's ability to sit down and rise from the floor.	Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
Secondary	360 Degree Turn Test	This test measures the time taken to turn 360 degrees to the left and right.	Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
Secondary	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.	Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).