Activity Based Locomotor Exercise PrOgram-Wait-list controllEd Research

Terminated

• Conditions: Spinal Cord Injuries
• Interventions: Behavioral: Activity-Based Locomotor Exercise Program (ABLE)

• Registration Number: NCT03261388
• Lead Sponsor: Allina Health System

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 available

Study Timeline

• Study Start: 2016-11-07
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-25
• Primary Completion: 2020-01-21
• Study Completion: 2020-01-21
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ABLE POWER Program	Activity-Based Locomotor Exercise Program (ABLE)	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.

Primary Outcome Measures

Name	Time	Method
Change in Neuromuscular Recovery Scale (NRS)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Craig Handicap Assessment and Reporting Technique (CHART)	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 Canadian Occupational Performance Measure (COPM)	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 American Spinal Injury Association Impairment Scale (AIS)	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.

Trial Locations

Locations (1)

Courage Kenny Rehabilitation Institute; 🇺🇸 Golden Valley, Minnesota, United States