N/A
Completed N=18
Development of a Multifunctional Rehabilitation Device for Persons With Parkinson's Disease
Source: ClinicalTrials.gov NCT05586490 ↗Enrolled (actual)
18
Serious AEs
2.1%
Results posted
Jan 2025
Primary outcomePrimary: (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 1 Total Scores — 7.28 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 1 Total Scores |
7.28 | — |
| PRIMARY (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 2 Total Scores |
23.72 | — |
| PRIMARY (Aim 1) Mean System Usability Scale (SUS) Total Scores |
83.19 | — |
| PRIMARY (Aim 2) Change in Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) |
18.761; 18.124 | 0.429 |
| PRIMARY (Aim 2) Change in Mean Duration of Balance During Romberg Test Condition |
26.25; 30 | 0.351 |
| PRIMARY (Aim 2) Change in Mean Response Time During the Stroop Stepping Test |
1.887; 1.874 | 0.937 |
| PRIMARY (Aim 2) Change in Mean of Time Taken to Complete Stroop Color Word Interference Test |
167.51; 152.71 | 0.044 sig |
| PRIMARY (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. |
7.65; 7.49; 8.53; 8.27; 6.83; 8.47 | 0.42 |
| PRIMARY (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. |
13.05; 12.72; 13.32; 12.40; 11.35; 11.92 | 0.986 |
| PRIMARY (Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest. |
5.00; 5.17; 4.33; 3.83; 4.5; 3.33 | 0.098 |
| PRIMARY (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. |
37.58; 33; 32.25; 36.83; 27.67; 36.58 | 0.0580 |
| PRIMARY (Aim 3) Mean Modified Hoehn and Yahr Stage at Baseline |
2.17; 1.92; 2.17 | — |
| PRIMARY (Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups. |
2.10; 1.92; 1.99; 1.92; 1.83; 1.97 | 0.816 |
| PRIMARY (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. |
162.25; 168.82; 167.76; 158.53; 163.19; 153.95 | 0.59 |
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
Data sourced from ClinicalTrials.gov (NCT05586490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.