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NCT00594178 · ClinicalTrials.gov registry record · NA

Palliative Strategies in Spinal Cord Injury (SCI)

A NA study, sponsored by University of Arkansas.

Completed
Registry status
NA
Development phase
17
Enrollment target

NCT00594178: Completed NA study, sponsored by University of Arkansas.

NCT00594178 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00594178, a NA study, has completed, sponsored by University of Arkansas.

COMPLETED
Registry status
NA
Development phase
17 participants
Enrollment target

Study Summary

Spinal cord injury (SCI) leads to muscle atrophy, hyperreflexia and spasticity, symptoms that decrease quality of life and prevent effective rehabilitation. Previous findings from our labs found that a passive cycling exercise program, motorized bicycle exercise training (MBET), in adult spinally transected animals reduced muscle atrophy and normalized hyperreflexia. We found that MBET could prevent the onset of hyperreflexia after spinal transaction, that MBET could also be used to rescue from hyperreflexia once it had set in, and that MBET could induce savings in normalization of reflexes after MBET ceased. We also demonstrated that MBET was effective in rescuing from hyperreflexia in a chronic ASIA B SCI patient, and that short-term MBET could lead to brief savings in normalization of reflexes once MBET ceased. The proposed studies will test the ability to MBET to prevent the onset of hyperreflexia in a group of acute SCI patients trained before hyperreflexia has had a chance to set in. In addition, the proposed research will attempt to confirm the possibility that long-term MBET in chronic SCI patients will rescue from hyperreflexia once it has set in, and also produce significant savings in normalization of reflexes if carried out for long periods of time. We will also test the possibility that MBET in acute and/or chronic SCI patients could reduce or prevent muscle atrophy. The experimental design calls for assessing muscle mass using MRI scans, bone density using Dual-Energy X-ray Absortiometry (DEXA) scans, spasticity measures and electrophysiological measurements to determine low frequency habituation of the H-reflex. Assessments will be carried out before MBET, during a 25 week MBET block of time, and during a 12 week post MBET monitoring period. Changes in muscle mass, bone density, spasticity scales and H-reflex habituation will be compared across these interventions and between treated SCI victims and a group of control acute and chronic SCI victims und

Primary Outcome

Lean muscle mass was measured with Dual-Energy X-ray Absortiometry (DEXA) scan, which uses low dose radiation to assess bone density and soft tissue density. pre and post, three month exercise protocol on a passivie motorized exercise bicycle.

Interventions

  • DEVICE Motorized bicycle exercise training

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2003-10
Est. Completion 2010-09
Phase NA
University of Arkansas

318 total trials

What the finished NCT00594178 record still lists

NCT00594178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Motorized bicycle exercise training is the first listed.

NCT00594178 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00594178 about?

NCT00594178 is a clinical study titled "Palliative Strategies in Spinal Cord Injury (SCI)". Spinal cord injury (SCI) leads to muscle atrophy, hyperreflexia and spasticity, symptoms that decrease quality of life and prevent effective rehabilitation. Previous findings from our labs found that a passive cycling exercise program, motorized bicycle exercise training (MBET), in adult spinally tr...

What is the current status of trial NCT00594178?

This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2003-10. Estimated completion is 2010-09.

What interventions are being tested in trial NCT00594178?

The interventions under investigation include: Motorized bicycle exercise training (DEVICE).

Who is sponsoring clinical trial NCT00594178?

This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00594178's enrollment target sits among peer trials

17 1871st of 2000 higher than 130 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 NCT00594178, the US trial registry maintained by the National Library of Medicine. NCT00594178 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.