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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 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.

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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.

Conditions Studied

Parkinson Disease

Interventions

  • BEHAVIORAL Augmented Reality Multi-Modal Training
  • BEHAVIORAL Traditional Multi-Modal Training

Study Locations (1)

Ohio

  • Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2020-12-10
Est. Completion 2022-08-08
Phase Phase 2

Sponsor

The Cleveland Clinic

688 total trials

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What the Registry Record Tells You About NCT04634331

The ClinicalTrials.gov registry entry for NCT04634331 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.