Mental Practice Impact on Gait and Cortical Organization in Spinal Cord Injury (SCI)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Incomplete Spinal Cord Injury |
Behavioral: Mental practice |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Mental Practice Impact on Gait and Cortical Organization in SCI |
- Gait velocity: The investigators are measuring the speed that people walk. [ Time Frame: 1-3 weeks before intervention; 1 week after intervention; 3 months after intervention ] [ Designated as safety issue: No ]
| Study Start Date: | September 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
-
Behavioral: Mental practice
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
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;
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More Information
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| Responsible Party: | Stephen Page, PhD, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01302522 History of Changes |
| Other Study ID Numbers: | 1R21AT003842-01 |
| Study First Received: | February 22, 2011 |
| Last Updated: | February 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013