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

Incomplete Spinal Cord Injury Clinical Trial

Official title:

Mental Practice Impact on Gait and Cortical Organization in SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302522
• Other study ID #: 1R21AT003842-01
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2011
• Last updated: February 23, 2011
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Incomplete Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Behavioral:
• Mental practice
All patients in the study will be administered a regimen of locomotor therapy (rehabilitative therapy working on walking). Half of the patients will also be administered a regimen in which they mentally rehearse the exercises that they have just physically performed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait velocity: The investigators are measuring the speed that people walk.		1-3 weeks before intervention; 1 week after intervention; 3 months after intervention	No