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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: Completed NA study of Spinal Cord Injury, sponsored by University of Miami.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The Jebsen Test is an assessment of hand function and improvement in hand function associated with therapeutic procedures. Individuals with cervical SCI are included in the target population for use of the test. The test is comprised of 7 subtests, including writing, turning over cards, picking up small common objects, simulated feeding, stacking checkers, picking up large light objects, and picking up large heavy objects.
Conditions Studied
Interventions
- OTHER Arm and hand training
Study Locations (1)
Florida
- The Miami Project to Cure Paralysis - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2007-08 |
| Est. Completion | 2013-08 |
| Phase | NA |
What the finished NCT01143597 record still lists
NCT01143597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (44% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01143597's enrollment target sits among peer trials
48 36th of 99 higher than 63 of 99 other Spinal Cord Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injury 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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