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Completed

NCT Number: NCT05586490

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

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multifunctional RehabilitationDevice (MRD)

Device

Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP

Other names: MRD

existing standard rehabilitation device

Device

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

Primary outcomes

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

    Time frame: After 1-hour session using the device

    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.

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

    Time frame: After 1-hour session using the device

    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.

  3. (Aim 1) Mean System Usability Scale (SUS) Total Scores

    Time frame: After 1-hour session using the device

    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.

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

    Time frame: After 2-week intervention

    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.

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

    Time frame: After 2-week intervention

    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.

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

    Time frame: After 2-week intervention

    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.

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

    Time frame: After 2-week intervention

    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).

  8. (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.

    Time frame: After 14-week intervention

    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.

  9. (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.

    Time frame: After 14-week intervention

    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.

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

    Time frame: After 14-week intervention

    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.

  11. (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.

    Time frame: After 14-week intervention

    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.

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

    Time frame: At baseline (descriptive statistic)

    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).

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

    Time frame: After 14-week intervention

    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.

  14. (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.

    Time frame: After 14-week intervention

    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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2022
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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