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Behavioral Intervention
Health Program for Spinal Cord Injury (LLS Trial)
N/A
Recruiting
Led By Susan Robinson-Whelen, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Traumatic spinal cord injury (SCI)
Use a manual or power wheelchair for mobility at least some of the time
Must not have
Cognitive impairment that significantly limits their ability to give informed consent, participate in the intervention, or complete study assessments as determined by an inability to correctly answer questions demonstrating study comprehension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to create a program to improve the health of people with spinal cord injuries as they age. It will test the effectiveness of the program in a controlled study and evaluate how it improves physical,
Who is the study for?
This trial is for individuals who are aging with a spinal cord injury (SCI). Specific criteria to join the study aren't provided, but typically participants would need to meet certain health conditions related to their SCI.
What is being tested?
The study is testing a new group intervention program called 'Living Longer and Stronger with SCI' designed to improve physical, psychological, and social health in people with SCI. It's compared against a control group in a randomized controlled trial.
What are the potential side effects?
Since this is not a drug or medical device trial, traditional side effects are not applicable. However, there may be emotional or psychological impacts from participating in the group intervention that will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a spinal cord injury due to trauma.
Select...
I use a wheelchair for moving around, at least occasionally.
Select...
I have had a spinal cord injury for 15 years or I am over 45.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I understand the study and can make decisions about my care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in physical health as assessed by the Interference scale
Change in physical health as assessed by the Pain Intensity scale
Change in physical health as assessed by the SCI Secondary Conditions Scale (SCI-SCS)
+8 moreSecondary study objectives
Change in health behaviors/behavioral symptoms as assessed by the Health Promoting Lifestyle Profile-II (HPLP-II)
Change in health behaviors/behavioral symptoms as assessed by the SCI-specific Health Behavior Questionnaire (HBQ)
Change in self efficacy as assessed by the Generalized Self-Efficacy Scale (GSES)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Living Longer and Stronger (LLS) interventionExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
949 Previous Clinical Trials
344,845 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
79 Previous Clinical Trials
9,667 Total Patients Enrolled
Susan Robinson-Whelen, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
175 Total Patients Enrolled
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