- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01302522
Mental Practice Impact on Gait and Cortical Organization in Spinal Cord Injury (SCI)
February 23, 2011 updated by: University of Cincinnati
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1-3 weeks before intervention; 1 week after intervention; 3 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
February 22, 2011
First Submitted That Met QC Criteria
February 23, 2011
First Posted (Estimate)
February 24, 2011
Study Record Updates
Last Update Posted (Estimate)
February 24, 2011
Last Update Submitted That Met QC Criteria
February 23, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21AT003842-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Incomplete Spinal Cord Injury
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University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingSCI - Spinal Cord Injury | Incomplete Spinal Cord InjuryUnited States
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