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Completed

NCT Number: NCT01302522

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Mental practice

Behavioral

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 names: Motor imagery

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

Mental Practice Impact on Gait and Cortical Organization in SCI

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 24, 2011
Registry last updated
Feb 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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