Palliative Strategies in Spinal Cord Injury (SCI)

Spinal Cord Injury Clinical Trial

Official title:

Palliative Strategies in Spinal Cord Injury (SCI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594178
• Other study ID #: 24179
• Secondary ID: PRN # 12903 NIH
• Status: Completed
• Phase: N/A
• First received: January 3, 2008
• Last updated: December 13, 2010
• Start date: October 2003
• Est. completion date: September 2010

Study information

• Verified date: December 2010
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: NIHUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Motorized bicycle exercise training
Passive exercise with a bicycle to bilateral legs. 5 days per week for 3 months

Locations

Country	Name	City	State
United States	Center for Translational Neuroscience #847	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	baseline and 3 months Post-exercise	No