Palliative Strategies in Spinal Cord Injury (SCI)

NCT ID: NCT00594178

Last Updated: 2011-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2010-09-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Exercise group

Group Type: EXPERIMENTAL

Motorized bicycle exercise training

Intervention Type: DEVICE

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

Interventions

Motorized bicycle exercise training

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Director, Center for Translational Neuroscience

Principal Investigators

Thomas S. Kiser, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Translational Neuroscience, UAMS

Edgar Garcia-Rill, PhD

Role: STUDY_DIRECTOR

Center for Translational Neuroscience, UAMS

Locations

Center for Translational Neuroscience #847

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

PRN # 12903 NIH

Identifier Type: -

Identifier Source: secondary_id

24179

Identifier Type: -

Identifier Source: org_study_id