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

This study has been completed.
Sponsor:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01302522
First received: February 22, 2011
Last updated: February 23, 2011
Last verified: February 2011

February 22, 2011
February 23, 2011
September 2008
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01302522 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Mental Practice Impact on Gait and Cortical Organization in Spinal Cord Injury (SCI)
Mental Practice Impact on Gait and Cortical Organization in SCI

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Incomplete Spinal Cord Injury
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.
Other Name: Motor imagery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
December 2010
July 2010   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01302522
1R21AT003842-01
Yes
Stephen Page, PhD, University of Cincinnati
University of Cincinnati
Not Provided
Not Provided
University of Cincinnati
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP