Spinal Cord InjuriesABLE-POWERNCT03261388
Activity Based Locomotor Exercise PrOgram-Wait-list controllEd Research
An observational study of Spinal Cord Injuries, run by Allina Health System at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Activity-Based Locomotor Exercise Program (ABLE)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2016to 21 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- The participant must NOT have previously participated in ABLE.
Trial locations and contacts
1 site in 1 country.
United States1 site
Courage Kenny Rehabilitation Institute
Golden Valley, Minnesota, 55422
About this study
Official title: ABLE POWER - Activity Based Locomotor Exercise PrOgram: Wait-list controllEd Research
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Activity-Based Locomotor Exercise Program (ABLE)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity-Based Locomotor Exercise Program (ABLE)Behavioural
The ABLE program is an intensive locomotor based intervention that is offered at the Golden Valley Courage Kenny Rehabilitation Institute.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Activity-Based Locomotor Exercise Program (ABLE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (3)
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start7 Nov 2016
- Primary completion21 Jan 2020
- Study completion21 Jan 2020
Why it stopped: Change in subject population/ABLE POWER program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Flinn, Allina Health System
- Investigators
- Nancy Flinn, PhD, OTR/L, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261388
- Sponsor's protocol ID
- CK-1604
- Acronym
- ABLE-POWER
- Status last verified
- Feb 2020
- First submitted
- 17 Aug 2017
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABLE POWER - Activity Based Locomotor Exercise PrOgram: Wait-list controllEd Research
- ClinicalTrials.gov ID
- NCT03261388
- Acronym / sponsor ID
- ABLE-POWER / CK-1604
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change in subject population/ABLE POWER program
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABLE POWER Program | – | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- The participant must NOT have previously participated in ABLE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ABLE POWER Program |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study was stopped early (reason given: Change in subject population/ABLE POWER program). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Flinn, PhD, OTR/L principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Allina Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in subject population/ABLE POWER program). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.