Clinical trial NCT03261388: Activity Based Locomotor Exercise PrOgram-Wait-list controllEd Research
Official title: ABLE POWER - Activity Based Locomotor Exercise PrOgram: Wait-list controllEd Research
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spinal Cord Injuries
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Change in Neuromuscular Recovery Scale (NRS)
timeFrame: 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
Secondary outcomes:
measure: Change in Canadian Occupational Performance Measure (COPM)
timeFrame: 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
measure: Change in Craig Handicap Assessment and Reporting Technique (CHART)
timeFrame: 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
measure: Change in American Spinal Injury Association Impairment Scale (AIS)
timeFrame: 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
Other outcomes:
Locations:
city: Golden Valley
country: United States
facility: Courage Kenny Rehabilitation Institute
state: Minnesota
Study officials:
affiliation: Allina Health
name: Nancy Flinn, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: