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Palliative Strategies in Spinal Cord Injury (SCI)

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motorized bicycle exercise training
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1. An incomplete spinal cord injury at a level of C4 to T12.
  • 2. 18 to 70 years of age.

Exclusion Criteria:

  • 1. Joint contractures and/or spasticity that would hamper upright posture or use of MBET
  • 2. A documented blood clot in the lower extremities
  • 3. A history of lower extremity fractures (excludes randomization to the PWBT).
  • 4. Pregnant women

Sites / Locations

  • Center for Translational Neuroscience #847

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Exercise group

Outcomes

Primary Outcome Measures

Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data
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.

Secondary Outcome Measures

Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan
Bone mineral density was measured with Dual-Energy X-ray Absortiometry (DEXA) scan pre and post, three month exercise protocol on a passive motorized exercise bicycle.

Full Information

First Posted
January 3, 2008
Last Updated
December 13, 2010
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00594178
Brief Title
Palliative Strategies in Spinal Cord Injury (SCI)
Official Title
Palliative Strategies in Spinal Cord Injury (SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 undergoing standard of care during the same period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Exercise group
Intervention Type
Device
Intervention Name(s)
Motorized bicycle exercise training
Intervention Description
Passive exercise with a bicycle to bilateral legs. 5 days per week for 3 months
Primary Outcome Measure Information:
Title
Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data
Description
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.
Time Frame
baseline and 3 months
Secondary Outcome Measure Information:
Title
Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan
Description
Bone mineral density was measured with Dual-Energy X-ray Absortiometry (DEXA) scan pre and post, three month exercise protocol on a passive motorized exercise bicycle.
Time Frame
baseline and 3 months Post-exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. An incomplete spinal cord injury at a level of C4 to T12. 2. 18 to 70 years of age. Exclusion Criteria: 1. Joint contractures and/or spasticity that would hamper upright posture or use of MBET 2. A documented blood clot in the lower extremities 3. A history of lower extremity fractures (excludes randomization to the PWBT). 4. Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas S. Kiser, MD
Organizational Affiliation
Center for Translational Neuroscience, UAMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edgar Garcia-Rill, PhD
Organizational Affiliation
Center for Translational Neuroscience, UAMS
Official's Role
Study Director
Facility Information:
Facility Name
Center for Translational Neuroscience #847
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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Palliative Strategies in Spinal Cord Injury (SCI)

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