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

Primary Purpose

Incomplete Spinal Cord Injury

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Mental practice

About this trial

This is an interventional treatment trial for Incomplete Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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;

Sites / Locations

Outcomes

Primary Outcome Measures

Gait velocity: The investigators are measuring the speed that people walk.

Secondary Outcome Measures

Full Information

NCT ID

NCT01302522

First Posted

February 22, 2011

Last Updated

February 23, 2011

Sponsor

University of Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT01302522

Brief Title

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

Official Title

Mental Practice Impact on Gait and Cortical Organization in SCI

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Cincinnati

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Incomplete Spinal Cord Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

Outcomes Assessor

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Mental practice

Other Intervention Name(s)

Motor imagery

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility 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;

12. IPD Sharing Statement

Learn more about this trial

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

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