Clinical trial NCT05586490: Development of a Multifunctional Rehabilitation Device for Persons With Parkinson's Disease
Official title: Development of a Multifunctional Rehabilitation Standing and Stepping Device for Persons With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: feasibility device testing
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2022-10-19
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: The primary purpose of this feasibility study is to assess human user acceptance of the device during 2 lab sessions (aim 1) from which the persons will proceed to 5 lab sessions (aim 2) and during in-home use (aim 3). The in-home aim will also include control persons to allow exploratory collection of clinical data that may provide preliminary outcome data to properly power a future phase 2 randomized clinical trial. The open label extension will provide information on the efficacy of using the device long-term.

While 45 persons may appear to be a larger than normal number for a device feasibility trial, because Parkinsons patients have a wide range of clinical symptoms, in order to acquire any meaningful data, some "spread" must be achieved. For example, 3 individuals in several different symptomatic categories. Further, there is some chance of attrition. Lastly, to be clear, details of device design may continue to be modified throughout the study.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 1 Total Scores
timeFrame: After 1-hour session using the device
measure: (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 2 Total Scores
timeFrame: After 1-hour session using the device
measure: (Aim 1) Mean System Usability Scale (SUS) Total Scores
timeFrame: After 1-hour session using the device
measure: (Aim 2) Change in Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG)
timeFrame: After 2-week intervention
measure: (Aim 2) Change in Mean Duration of Balance During Romberg Test Condition
timeFrame: After 2-week intervention
measure: (Aim 2) Change in Mean Response Time During the Stroop Stepping Test
timeFrame: After 2-week intervention
measure: (Aim 2) Change in Mean of Time Taken to Complete Stroop Color Word Interference Test
timeFrame: After 2-week intervention
measure: (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.
timeFrame: After 14-week intervention
measure: (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.
timeFrame: After 14-week intervention
measure: (Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest.
timeFrame: After 14-week intervention
measure: (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.
timeFrame: After 14-week intervention
measure: (Aim 3) Mean Modified Hoehn and Yahr Stage at Baseline
timeFrame: At baseline (descriptive statistic)
measure: (Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups.
timeFrame: After 14-week intervention
measure: (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.
timeFrame: After 14-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Chatkaew Pongmala, PhD
role: PRINCIPAL_INVESTIGATOR
References: