Oregon Health Science University
Portland, Oregon, 97239, United States
Location status: Recruiting
NCT Number: NCT05680597
This project will determine the feasibility and efficacy of remote assessment and treatment of balance disorders in people with Parkinson's disease.
Interested in participating?
Request Info55 year–85 year
All sexes
Interventional
Not applicable
Portland, Oregon, 97239, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Opal sensors; APDM Wearable Technologies
Time frame: Pre and 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.
Time frame: Pre and 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.
Time frame: after rehabilitation
The PGIC is one question rated on a seven point Likert scale measuring impression of change after intervention.
Time frame: Pre and Post rehabilitation
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
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
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
This questionnaire asks about intensity and type of physical activity performed in the last 7 days
Time frame: 8-10 hours per day for 7 days; Pre and Post rehabilitation
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: Pre and Post rehabilitation
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
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
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
This is a questionnaire where you will report on the area in which you live.
Time frame: Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days).
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).
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).
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).
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).
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.
Contact information is provided by the study sponsor or research team.
Laurie King, PhD
CONTACT
Martina Mancini, PhD
CONTACT
Oregon Health and Science University
Other
Balance Tele-rehabilitation With Wearable Technology for Older Adults With Parkinson's Disease
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