Palliative Strategies in Spinal Cord Injury (SCI)

NCT00594178 | Completed Results

• 2 other identifiers: 24179PRN # 12903 NIH
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 3 months

Secondary Outcomes (1)

• Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan

  baseline and 3 months Post-exercise

Study Arms (1)

A

EXPERIMENTAL

Exercise group

Device: Motorized bicycle exercise training

Interventions

Motorized bicycle exercise training DEVICE

Passive exercise with a bicycle to bilateral legs. 5 days per week for 3 months

A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Center for Translational Neuroscience #847

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

This was a pilot study to determine if a passive exercise bicycle would suppress the H-reflex after a spinal cord injury. We were not able to collect stable H-reflex data. However, the Dual-Energy X-ray Absortiometry (DEXA) scan data was useable.

Results Point of Contact

• Title: Thomas S. Kiser
• Organization: Dept of PM&R; University of Arkansas for Medical Sciences

kiserthomass@uams.edu

501-221-1311

Study Officials

• Thomas S. Kiser, MD

  Center for Translational Neuroscience, UAMS

  PRINCIPAL INVESTIGATOR

• Edgar Garcia-Rill, PhD

  Center for Translational Neuroscience, UAMS

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 15, 2008
• Study Start: October 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2010
• Last Updated: January 13, 2011
• Results First Posted: January 13, 2011

Record last verified: 2010-12

Locations

US (1)