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Trial record 5 of 26 for:    Injuries | Spinal Cord Injuries | ( Map: Minnesota, United States )

Activity Based Locomotor Exercise PrOgram—Wait-list controllEd Research (ABLE-POWER)

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ClinicalTrials.gov Identifier: NCT03261388
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Nancy Flinn, Allina Health System

Tracking Information
First Submitted Date August 17, 2017
First Posted Date August 25, 2017
Last Update Posted Date August 28, 2019
Actual Study Start Date November 7, 2016
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 22, 2017)
Change in Neuromuscular Recovery Scale (NRS) [ Time Frame: At entry to wait list, after 6 months, at enrollment to the ABLE program (6-13 months after entry to wait list), 6 months post entry to ABLE, 12 months post entry to ABLE ]
The NRS measures motor function in individuals with SCI without allowing compensatory motions. This 15 item measure is collected while the participants are on the mat, in sitting, standing, and on the weight supported treadmill. Items include upper extremity function, lower extremity function, sitting, sit to stand, standing, and locomotor items.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03261388 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 22, 2017)
  • Change in Canadian Occupational Performance Measure (COPM) [ Time Frame: At entry to wait list, after 6 months, at enrollment to the ABLE program (6-13 months after entry to wait list), 6 months post entry to ABLE, 12 months post entry to ABLE ]
    The COPM is a client-centered measure of performance and satisfaction using client identified meaningful activities and has been used with individuals who have SCI as a means to identify personally meaningful goals
  • Change in Craig Handicap Assessment and Reporting Technique (CHART) [ Time Frame: At entry to wait list, after 6 months, at enrollment to the ABLE program (6-13 months after entry to wait list), 6 months post entry to ABLE, 12 months post entry to ABLE ]
    The Craig Handicap Assessment and Reporting Technique (CHART) is a measure of social participation in individuals with SCI.
  • Change in American Spinal Injury Association Impairment Scale (AIS) [ Time Frame: At entry to wait list, at enrollment to the ABLE program (6-13 months after entry to wait list), 12 months post entry to ABLE ]
    The American Spinal Injury Association Impairment Scale (AIS) classifies the motor and sensory impairment that results from a SCI, and is the gold standard for identifying completeness of a SCI.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Activity Based Locomotor Exercise PrOgram—Wait-list controllEd Research
Official Title ABLE POWER - Activity Based Locomotor Exercise PrOgram: Wait-list controllEd Research
Brief Summary At Courage Kenny Rehabilitation Institute, rehabilitation for individuals with spinal cord injury (SCI) is being led by the NIH funded NeuroRecovery Network (NRN) Community Fitness and Wellness Program through the Activity-Based Locomotor Exercise Program (ABLE). Any individual with a spinal cord injury who is eligible for the ABLE Program is eligible for participation in the NeuroRecovery Network Research Project (NRN). The purpose of the ABLE POWER Study is to evaluate the effectiveness of activity-based locomotor exercise programs in individuals with SCI through a wait-list controlled design. Individuals who have a spinal cord injury and are on the wait list for ABLE will be enrolled in this project for a year while they wait for an opening in the ABLE program. Changes that occur while participants are on the wait list will be compared to changes that occur after they are enrolled in ABLE. A difference in the rate of improvement after enrollment in the intervention would be attributed to the ABLE intervention. Individuals participating in the ABLE program will receive the ABLE intervention regardless of participation in the ABLE POWER research study. In this design, there will be two measures in the year prior to enrollment in ABLE, and two measures in the year after enrollment, and the two time periods would be compared to the data collected at enrollment into ABLE.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants for this research study will be recruited from adults with spinal cord injury (SCI) on the wait list for the Neurorecovery Network (NRN) research study. These individuals have injuries at all spinal levels and categories of completeness.
Condition Spinal Cord Injuries
Intervention Behavioral: Activity-Based Locomotor Exercise Program (ABLE)
The ABLE program is an intensive locomotor based intervention that is offered at the Golden Valley Courage Kenny Rehabilitation Institute.
Study Groups/Cohorts ABLE POWER Program
Participants on the Activity-Based Locomotor Exercise Program (ABLE) waitlist will be enrolled prior to beginning the ABLE program. This waiting period will allow outcomes to be compared (in the same participant) before receiving the intervention and after receiving the intervention.
Intervention: Behavioral: Activity-Based Locomotor Exercise Program (ABLE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 22, 2017)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2022
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The participant must be eligible for the Neurorecovery Network (NRN) Study. Eligibility criteria for the NRN study are as follows: The participant must have a spinal cord injury, at any spinal level or time since injury. Individuals with uncontrolled diabetes, uncontrolled seizures, uncontrolled autonomic dysreflexia, uncontrolled hypotension, unstable angina, history of heart attack, osteoporosis, or weight of more than 275 pounds (due to the weight limit of the partial weight supported treadmill system) are not eligible.
  • The participant must be on the ABLE wait list.

Exclusion Criteria:

• The participant must NOT have previously participated in ABLE.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Nancy Flinn, PhD, OTR/L 612-863-1418 Nancy.Flinn@allina.com
Contact: Emily Shoemaker, MPH 612-863-0324 Emily.Shoemaker@allina.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03261388
Other Study ID Numbers CK-1604
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Nancy Flinn, Allina Health System
Study Sponsor Allina Health System
Collaborators Not Provided
Investigators
Principal Investigator: Nancy Flinn, PhD, OTR/L Allina Health
PRS Account Allina Health System
Verification Date August 2019