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NCT00462449 · ClinicalTrials.gov registry record · NA

Efficacy of Functional Electrical Stimulation (FES) in Persons Receiving Botulinum Neurotoxin for Upper Extremity Spasticity

A NA study, sponsored by University of Pittsburgh.

Completed
Registry status
NA
Development phase
23
Enrollment target

NCT00462449: Completed NA study, sponsored by University of Pittsburgh.

NCT00462449 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00462449, a NA study, has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
NA
Development phase
23 participants
Enrollment target

Study Summary

FES is a form of treatment with a device to aid movement in people who have had damage to their brain or spinal cord. Small electrical impulses are used to excite/stimulate the nerves that supply paralyzed muscles. This activates those muscles, enabling them to produce basic but useful movement. Self-adhesive patches (electrodes) are placed on the skin close to the nerve that supplies the muscle and are connected by wires to a stimulator that produces the impulses. In this way, FES is used to correct the muscle weakness that is caused by injury to the brain or spinal cord. Repetitive task practice is an "activity-based" therapy program that has been shown to enhance the recovery of hand and arm functions after stroke. This therapy consists of a set of training activities that are designed by a qualified therapist specific to your functional abilities that are to be performed with the impaired hand. These activities are designed to stimulate functional improvement with repetitive practice. Spasticity is a nervous system disorder where certain muscles are continuously contracted. Botox injections are commonly used to help to reduce spasticity in areas of the body with increased muscle tone. This research is designed to look at any additional benefit that may occur when Botox injections are combined with specific occupational therapy exercises and with a device that uses functional electrical stimulation (FES) to help improve muscle function after stroke.

Primary Outcome

upper extremity function during activities of daily living based on observer ratings. Scale runs 0 (not used) to 5 (normal function). No subscales used.

Interventions

  • DEVICE Functional Electrical Stimulation (FES) through the Ness H200

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2007-11
Est. Completion 2010-01
Phase NA
University of Pittsburgh

1,238 total trials

What the finished NCT00462449 record still lists

NCT00462449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Functional Electrical Stimulation (FES) through the Ness H200 is the first listed.

NCT00462449 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00462449 about?

NCT00462449 is a clinical study titled "Efficacy of Functional Electrical Stimulation (FES) in Persons Receiving Botulinum Neurotoxin for Upper Extremity Spasticity". FES is a form of treatment with a device to aid movement in people who have had damage to their brain or spinal cord. Small electrical impulses are used to excite/stimulate the nerves that supply paralyzed muscles. This activates those muscles, enabling them to produce basic but useful movement. Sel...

What is the current status of trial NCT00462449?

This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2007-11. Estimated completion is 2010-01.

What interventions are being tested in trial NCT00462449?

The interventions under investigation include: Functional Electrical Stimulation (FES) through the Ness H200 (DEVICE).

Who is sponsoring clinical trial NCT00462449?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00462449's enrollment target sits among peer trials

23 1755th of 2000 higher than 245 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT00462449, the US trial registry maintained by the National Library of Medicine. NCT00462449 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.