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
  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

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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 September 22, 2014