Mental Practice Impact on Gait and Cortical Organization in Spinal Cord Injury (SCI)

Phase 2

Completed

• Conditions: Incomplete Spinal Cord Injury

• Registration Number: NCT01302522
• Lead Sponsor: University of Cincinnati

Brief Summary

Spinal cord injury (SCI) is a disabling condition that impairs fundamental abilities, such as ambulation, respiration, and toileting. Compromised ambulation is a common, devastating impairment following SCI. Yet, despite the fundamental desire to walk, no conventional rehabilitation regimen reliably improves ambulation after SCI, and many SCI patients do not have reliable transportation access, decreasing community integration and access to needed services, including rehabilitation. Little is also known about the subtle neural events that may predict motor recovery in incomplete SCI patients. This study will test a novel, safe, easy to implement technique that has shown promise in improving gait in incomplete SCI patients. The investigators expect that this study will confirm the efficacy of this technique, by showing that it increases the speed and efficiency of walking. This outcome is expected to produce a therapy that improves outcomes and health, and reduces care costs, for community dwelling patients with incomplete SCI.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2010-07
• Study Completion: 2010-12
• Status Verified: 2011-02
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-23
• Last Update Submitted: 2011-02-23
• Study First Posted: 2011-02-24
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• age > 18 years old;
• incomplete SCI (ASIA Grade C or D), experienced > 1 year prior to enrollment;
• motor grade of > 1 < 3 in the quads, hamstrings, and hip flexors, and ability to ambulate with at least a maximal assist;
• range of motion in the lower limbs within functional limits;
• motor function in at least half of ASIA key lower extremity muscles with strength < or > 3/5;
• able to ambulate at least 10 meters with 1 person assistance and/or assistive device;
• medically stable (ie, no bladder infection; decubiti); (8) stable dosage of antispasticity medications for duration of study

Exclusion Criteria

• excessive spasticity in the lower limbs as measured by a score of > 3 on the Modified Ashworth Spasticity Scale;
• excessive pain in the lower limbs as measured by a score of > 5 on a Visual Analog Scale or > 8/10 with a clarified scaled picture graph;
• moderate to severe osteoporosis, as indicated by the patient's physician;
• heterotropic ossification, as indicated by the patient's physician;
• psychological conditions that would contraindicate participation in the program and no abnormalities of attention, with minimum cognitive capacity present sufficient to participate in MP;
• fracture or fracture history in the lower limbs (individuals with a remote history of fractures may be included at discretion of the study physical therapists at each site);
• enrolled in any form of rehabilitation;
• for subjects to be administered fMRI, implant containing electrical circuitry, generating electrical signals, or having moving metal parts, metal pins or plates above the waist, orthodontic braces, or other positives on a standard checklist of MRI exclusion criteria used by the Radiology Department;
• pregnant;
• DSM-IV Major Depressive Episode symptom criteria of > 5/9 as exclusion threshold instead of CESD;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gait velocity: The investigators are measuring the speed that people walk.	1-3 weeks before intervention; 1 week after intervention; 3 months after intervention