Development of a Multifunctional Rehabilitation Device for Persons With Parkinson's Disease

NCT05586490 | Completed Results FDA Device

• 2 other identifiers: HUM00216022a1R41NS1129418
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers have developed a multifunctional rehabilitation device that will be tested in this feasibility trial across three sub-studies: (i) dual session in-lab; (ii) multi-session in-lab and (iii) in the participant's home. A long-term outcome is to test possible benefits of this device (if accepted by the user Parkinson population) on motor and cognitive functions in a clinical trial in a future study. Participants who receive a device during the in-home trial will have the option to keep the device for up to two years in an open label extension. During this extension, participants can optionally provide feedback on their user experience such as discomfort.

Conditions

Parkinson Disease

Keywords

feasibility device testing

Outcome Measures

Primary Outcomes (14)

• (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 1 Total Scores

  Completed at 2nd study visit after a 1-hour session using the device. UAQ part 1 assesses potential difficulties experienced while using the device. UAQ part 1 scores range from 0 to 90, with lower scores indicating fewer difficulties experienced.

  After 1-hour session using the device

• (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 2 Total Scores

  Completed at 2nd study visit after a 1-hour session using the device. UAQ part 2 assesses participant preferences for using the device. UAQ part 2 scores range from 0 to 30, with higher scores indicating greater personal preference for using the device.

  After 1-hour session using the device

• (Aim 1) Mean System Usability Scale (SUS) Total Scores

  Completed at 2nd study visit after a 1-hour session using the device. SUS is a questionnaire consisting of 10 Likert-scale questions to assess usability of the device. Benchmarked scores range from 0 to 100, with higher scores indicating better usability of the device.

  After 1-hour session using the device

• (Aim 2) Change in Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG)

  Mobility test that evaluates the amount of time it takes the participants to stand, walk 10 feet, turn around, walk, and sit back down. Improved performance is indicated by lower time to complete measured in seconds.

  After 2-week intervention

• (Aim 2) Change in Mean Duration of Balance During Romberg Test Condition

  Balance test that evaluates how long participants are able to stand on a foam pillow before losing balance. Improved performance is indicated by longer balance duration.

  After 2-week intervention

• (Aim 2) Change in Mean Response Time During the Stroop Stepping Test

  During this test, subjects make steps based on congruent (stimulus prompts the stepping response) and incongruent (stimulus prompts inhibition of the stepping response) arrows and sounds. This will be used to compare the mean response time for stepping from pre and post intervention visits to determine if reaction time improves (indicated by a decrease in response time). Mean times include responses to both congruent and incongruent stimuli.

  After 2-week intervention

• (Aim 2) Change in Mean of Time Taken to Complete Stroop Color Word Interference Test

  During this test, participants read congruent and incongruent colored names of colors. This will be used to compare the number of incorrect responses and the time it takes to complete the test from pre and post intervention visits to determine if inhibitory control improves (indicated by decrease of incorrect responses and completion time).

  After 2-week intervention

• (Aim 3) Difference in Effect of Study Intervention on Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) in Study Device Group Versus Control Groups.

  Mobility test that evaluates the amount of time it takes the participants to stand, walk 10 feet, turn around, walk, and sit back down. Improved performance is indicated by lower time to complete measured in seconds.

  After 14-week intervention

• (Aim 3) Difference in Effect of Intervention on Mean Time to Complete the Instrumented Stand and Walk Test (iSAW) in Study Device Group Versus Control Groups.

  Mobility test that evaluates the amount of time it takes the participant to walk 10 feet, make a turn around a cone, and return to the starting position. Improved performance is indicated by lower time to complete measured in seconds.

  After 14-week intervention

• (Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest.

  Balance test that evaluates how long participants are able to stand on surfaces of varying firmness with eyes open and closed. Domain scores range from 0 to 6 with higher scores indicating stronger sensory postural control.

  After 14-week intervention

• (Aim 3) Difference in Effect of Intervention on Mean Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score in Study Device Group Versus Control Groups.

  Movement Disorder Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS part III) is the motor examination portion of the UPDRS evaluation. Scores range from 0-132, with higher scores indicating greater severity of motor symptoms.

  After 14-week intervention

• (Aim 3) Mean Modified Hoehn and Yahr Stage at Baseline

  The Hoehn and Yahr scale is a widely used clinical rating scale to categorize the progression of Parkinson's disease into stages ranging no disease (0) to wheelchair bound (5).

  At baseline (descriptive statistic)

• (Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups.

  During this test, subjects make steps based on congruent (stimulus prompts the stepping response) and incongruent (stimulus prompts inhibition of the stepping response) arrows and sounds. These responses are combined to compare the response time for stepping from pre and post intervention visits to determine if reaction time improves (indicated by a decrease in response time). Mean times include responses to both congruent and incongruent stimuli.

  After 14-week intervention

• (Aim 3) Difference in Effect of Study Device Intervention on Time Taken to Complete Stroop Color Word Interference Test in Study Device Group Versus Control Groups.

  During this test, participants read congruent and incongruent colored names of colors. This will be used to compare the number of incorrect responses and the time it takes to complete the test from pre and post intervention visits to determine if inhibitory control improves (indicated by decrease of incorrect responses and completion time).

  After 14-week intervention

Study Arms (3)

In-lab and in home feasibility testing of research device in people with Parkinson's disease (PwP)

EXPERIMENTAL

Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use the experimental device in home feasibility testing (aim 3). This arm will be asked to participate in the open label extension.

Device: Multifunctional RehabilitationDevice (MRD)

In-home feasibility testing (alternate device)

ACTIVE COMPARATOR

Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension.

Device: Multifunctional RehabilitationDevice (MRD); Device: existing standard rehabilitation device

In-home feasibility testing (no device in at home portion)

OTHER

Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3)

Device: Multifunctional RehabilitationDevice (MRD)

Interventions

Multifunctional RehabilitationDevice (MRD) DEVICE

Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP

Also known as: MRD

In-home feasibility testing (alternate device); In-home feasibility testing (no device in at home portion); In-lab and in home feasibility testing of research device in people with Parkinson's disease (PwP)

existing standard rehabilitation device DEVICE

existing standard rehabilitation device to be used for in-home comparison testing for aim 3

In-home feasibility testing (alternate device)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's disease
• Willing and able to comply with study requirements

You may not qualify if:

• Parkinson's disease dementia
• Parkinsonism plus syndromes
• Inability to stand, step, or walk without an assistive device
• History of symptoms in stance that preclude safe and comfortable participation, such as severe dizziness and lightheadedness, severe orthostasis, severe symptomatic leg or back musculoskeletal pain, painful neuropathy, significant ankle edema, or medication side effects
• History of symptomatic cardiovascular or pulmonary disease interfering with stance
• History of active rheumatic arthritis
• History of uncontrolled chronic pain syndrome
• Any other history of medical or psychiatric comorbidity precluding safe participation in the project
• Venous stasis or severe varicosities

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Chatkaew Pongmala, PhD
• Organization: University of Michigan

pchatkae@umich.edu

734-936-1168

Study Officials

• Chatkaew Pongmala, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Model Details: The feasibility study will involve a sequential stage of device feasibility testing with the initial aims 1 and 2 being a single group and the in-home feasibility testing will involve controls persons for an exploratory data collection. The same participants are asked to proceed sequentially through the three phase of the study. Participants in the third sub-study will then be asked to complete the open label extension.

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 19, 2022
• Study Start: October 13, 2022
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)