Activity Based Locomotor Exercise PrOgram—Wait-list controllEd Research

Spinal Cord Injuries Clinical Trial

— ABLE-POWER  

Official title:

ABLE POWER - Activity Based Locomotor Exercise PrOgram: Wait-list controllEd Research

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03261388
• Other study ID #: CK-1604
• Status: Terminated
• Start date: November 7, 2016
• Est. completion date: January 21, 2020

Study information

• Verified date: February 2020
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: January 21, 2020
• Est. primary completion date: January 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	Courage Kenny Rehabilitation Institute	Golden Valley	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Neuromuscular Recovery Scale (NRS)	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.	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	Change in Canadian Occupational Performance Measure (COPM)	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	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	Change in Craig Handicap Assessment and Reporting Technique (CHART)	The Craig Handicap Assessment and Reporting Technique (CHART) is a measure of social participation in individuals with SCI.	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	Change in American Spinal Injury Association Impairment Scale (AIS)	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.	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