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NCT00508755 · ClinicalTrials.gov registry record · NA

Feasibility and Practice Characteristics of FNS and Gait Robot

A NA study, sponsored by US Department of Veterans Affairs.

Completed
Registry status
NA
Development phase
6
Enrollment target

NCT00508755: Completed NA study, sponsored by US Department of Veterans Affairs.

NCT00508755 is a NA study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00508755, a NA study, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
NA
Development phase
6 participants
Enrollment target

Study Summary

Conventional therapies do not restore normal gait for many stroke survivors. The long-term goal of this work is to restore volitional lower limb motor control and gait following stroke. In our prior work, we demonstrated that it was feasible to provide a clinically operated, combined treatment of body weight supported treadmill training alone (BWSTT) + functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM). Specific Aims and Hypothesis The purpose or Specific Aim of the study is to test the feasibility and gait training potential of combining the Lokomat and FNS-IM for stroke survivors. Given the feasibility of our clinically operated combination of BWSTT + FNS-IM, we propose to test the feasibility of the combination of Lokomat + FNS-IM. Hypothesis I. It is feasible to utilize a clinically operated combination of Lokomat + functional neuromuscular stimulation (FNS) with intramuscular (IM) electrodes (FNS-IM). Treatment Procedures. The subjects will be treated for three months, four sessions/week (for a total of 48 treatment visits). A given session will be 1 hrs, with the time divided into thirds as follows: 1) hr coordination exercise; 2) hr over ground gait training; and 3) hr Lokomat gait training. FNS-IM will be used in all three aspects of the protocol, unless the subject is capable of volitionally executing a given movement or gait component. Population. The subjects will be chronic stroke survivors (\>6 months after the stroke).

Primary Outcome

Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES.

Interventions

  • DEVICE Gait Robot
  • DEVICE Functional Neuromuscular stimulation with intramuscular electrodes

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2005-08
Est. Completion 2009-08
Phase NA
US Department of Veterans Affairs

632 total trials

What the finished NCT00508755 record still lists

NCT00508755 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which Gait Robot is the first listed.

NCT00508755 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00508755 about?

NCT00508755 is a clinical study titled "Feasibility and Practice Characteristics of FNS and Gait Robot". Conventional therapies do not restore normal gait for many stroke survivors. The long-term goal of this work is to restore volitional lower limb motor control and gait following stroke. In our prior work, we demonstrated that it was feasible to provide a clinically operated, combined treatment of bo...

What is the current status of trial NCT00508755?

This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2005-08. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00508755?

The interventions under investigation include: Gait Robot (DEVICE), Functional Neuromuscular stimulation with intramuscular electrodes (DEVICE).

Who is sponsoring clinical trial NCT00508755?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00508755's enrollment target sits among peer trials

6 1983rd of 2000 higher than 13 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 NCT00508755, the US trial registry maintained by the National Library of Medicine. NCT00508755 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.