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NCT03416842 · ClinicalTrials.gov registry record · Phase 1

Home Exercise With Wearable Sensors

A Phase 1 study, sponsored by Burke Medical Research Institute.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target

NCT03416842: Completed Phase 1 study, sponsored by Burke Medical Research Institute.

NCT03416842 is a Phase 1 study that has completed, run by Burke Medical Research Institute. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03416842, a Phase 1 study, has completed, sponsored by Burke Medical Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

Repetitious motor therapy has been shown to yield the greatest improvement in motor function in those who suffer hemiplegia because of a neurological impairment. However, motor therapy remains largely clinically based due to the absence of quantitative home-based therapy technology or equipment. With the current lack of accountability, patient adherence to home exercise physical therapy programs is estimated to be as low as 35%. In response, some companies have extended the applications of their motion capture devices to be used for home-based physical therapy. However, the technologies often have not passed their initial stages of development. In contrast, a company named 4D Motion is actively working alongside the Restorative Neurology Clinic at Burke Medical Research Institute to develop a motion capture system tailored to the motor rehabilitation of hemiplegic stroke patients. This device is driven by a user's active range of motion and does not impart electrical or mechanical stimulation to the user. The device does not force the user beyond their active range of motion and does not apply resistance to motion that limits the user's capability. The 4D Motion capture system is only used to record what the patient is doing and to promote adherence to their prescribed physical therapy plan.

Primary Outcome

Measure of the number of days that the participant adheres to the prescribed therapy plan (completion of 1000 movements). Goal is to have participants perform 1000 movements per day over 30 days.

Interventions

  • DEVICE Training with 4D Motion Capture Device

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2018-02-01
Est. Completion 2018-12-31
Phase Phase 1
Burke Medical Research Institute

11 total trials

What the finished NCT03416842 record still lists

NCT03416842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which Training with 4D Motion Capture Device is the first listed.

NCT03416842 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03416842 about?

NCT03416842 is a clinical study titled "Home Exercise With Wearable Sensors". Repetitious motor therapy has been shown to yield the greatest improvement in motor function in those who suffer hemiplegia because of a neurological impairment. However, motor therapy remains largely clinically based due to the absence of quantitative home-based therapy technology or equipment. Wit...

What is the current status of trial NCT03416842?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-02-01. Estimated completion is 2018-12-31.

What interventions are being tested in trial NCT03416842?

The interventions under investigation include: Training with 4D Motion Capture Device (DEVICE).

Who is sponsoring clinical trial NCT03416842?

This trial is sponsored by Burke Medical Research Institute, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03416842's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03416842, the US trial registry maintained by the National Library of Medicine. NCT03416842 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.