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NCT01143597 · ClinicalTrials.gov registry record · NA

Improving Hand and Arm Function After Spinal Cord Injury (SCI)

A NA study of Spinal Cord Injury, sponsored by University of Miami.

Completed
Registry status
NA
Development phase
48
Enrollment target
1
Study location

NCT01143597 is a NA study of Spinal Cord Injury that has completed, run by University of Miami. The registered enrollment target is 48 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01143597, a NA study of Spinal Cord Injury, has completed, sponsored by University of Miami.

COMPLETED
Registry status
NA
Development phase
48 participants
Enrollment target
1
Study location

Study Summary

The long-term goal of this project is to develop rehabilitation strategies that facilitate optimal restoration of skilled hand use in individuals with spinal cord injury (SCI). The objective of the studies proposed in this application is to determine whether a protocol of massed practice + somatosensory stimulation (MP+SS) is more effective for improving skilled hand use compared to a somatosensory stimulation (SS) alone, and to determine whether these approaches are each more effective than traditional therapy (consisting of conventional resistance training; CRT). Specific Aim I: In individuals with chronic incomplete tetraplegia, quantify changes in skilled hand use and sensory function associated with either: massed practice training combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional resistance training \[CRT\]), and compare differences among groups. The investigators hypothesize that: H1.1: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor function (Jebsen-Taylor Hand Function Test and Chedoke-McMaster Arm and Hand Activity Inventory) and sensory function (quantitative sensory tests; QST) will be greater in individuals who are trained using MP+SS compared to the SS and RT groups. H1.2: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor function and sensory function tests will be greater in individuals who are trained using SS compared to CRT. H1.3: At 6 months post training, motor and sensory gains will be retained by the MP+SS and SS groups. Specific Aim 2: In individuals with chronic incomplete tetraplegia, quantify changes in cortical and spinal neurophysiology associated with either: massed practice combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional resistance training \[CRT\]), and compare differences among groups. The investigators hypothesize that, after 4 weeks: H2.1: Measures

Conditions Studied

Spinal Cord Injury

Interventions

  • OTHER Arm and hand training

Study Locations (1)

Florida

  • The Miami Project to Cure Paralysis - Miami

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2007-08
Est. Completion 2013-08
Phase NA

Sponsor

University of Miami

721 total trials

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What the Registry Record Tells You About NCT01143597

The ClinicalTrials.gov registry entry for NCT01143597 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (44% lower). The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 1 intervention - of which Arm and hand training is the first listed.

NCT01143597 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT01143597 about?

NCT01143597 is a clinical study titled "Improving Hand and Arm Function After Spinal Cord Injury (SCI)". The long-term goal of this project is to develop rehabilitation strategies that facilitate optimal restoration of skilled hand use in individuals with spinal cord injury (SCI). The objective of the studies proposed in this application is to determine whether a protocol of massed practice + somatosen...

What is the current status of trial NCT01143597?

This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2007-08. Estimated completion is 2013-08.

What conditions does trial NCT01143597 study?

This clinical trial studies the following conditions: Spinal Cord Injury.

What interventions are being tested in trial NCT01143597?

The interventions under investigation include: Arm and hand training (OTHER).

Who is sponsoring clinical trial NCT01143597?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01143597 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.