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NCT04634331 · ClinicalTrials.gov registry record · Phase 2
Dual-task Augmented Reality Treatment for Parkinson's Disease
A Phase 2 study of Parkinson Disease, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT04634331: Completed Phase 2 study of Parkinson Disease, sponsored by The Cleveland Clinic.
NCT04634331 is a Phase 2 study of Parkinson Disease that has completed, run by The Cleveland Clinic. The registered enrollment target is 51 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04634331, a Phase 2 study of Parkinson Disease, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
Activities of daily living (ADL) frequently involve the simultaneous performance of two or more tasks, such as crossing the street while holding a conversation, commonly referred to as dual tasking. The simultaneous performance of a motor and a cognitive task increases postural instability, gait dysfunction, and may increase fall rates in Parkinson's disease (PD). The goal of this project is to evaluate the effectiveness of utilizing a digital therapeutic, Dual-task Augmented Reality Treatment (DART) protocol, for the treatment of postural instability and gait dysfunction (PIGD) in individuals with PD. A randomized controlled trial will be conducted at the Main Campus of the Cleveland Clinic (Cleveland, OH). A total of 50 individuals with Parkinson's disease will be randomized into 1) a traditional multi-modal training group, or 2) multi-modal training administered via an augmented reality headset. Multi-modal therapy is where the participant practices performing two things at once (i.e. marching while answering math questions). Augmented reality is a type of head-worn technology that allows the individual to see the real world and places holograms in the space. Both groups will exercise 2x/week for a total of 8 weeks. Assessments involving walking, balancing, and turning will be completed to assess the efficacy of the treatment.
Primary Outcome
Walking speed (m/s) on a self-paced treadmill during single and dual task conditions
Conditions Studied
Interventions
- BEHAVIORAL Augmented Reality Multi-Modal Training
- BEHAVIORAL Traditional Multi-Modal Training
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2020-12-10 |
| Est. Completion | 2022-08-08 |
| Phase | Phase 2 |
What the finished NCT04634331 record still lists
NCT04634331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which Augmented Reality Multi-Modal Training is the first listed.
NCT04634331 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04634331 about?
NCT04634331 is a clinical study titled "Dual-task Augmented Reality Treatment for Parkinson's Disease". Activities of daily living (ADL) frequently involve the simultaneous performance of two or more tasks, such as crossing the street while holding a conversation, commonly referred to as dual tasking. The simultaneous performance of a motor and a cognitive task increases postural instability, gait dys...
What is the current status of trial NCT04634331?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2020-12-10. Estimated completion is 2022-08-08.
What conditions does trial NCT04634331 study?
This clinical trial studies the following conditions: Parkinson Disease.
What interventions are being tested in trial NCT04634331?
The interventions under investigation include: Augmented Reality Multi-Modal Training (BEHAVIORAL), Traditional Multi-Modal Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT04634331?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04634331 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04634331's enrollment target sits among peer trials
51 153rd of 297 higher than 144 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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