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Splinting application for HIV/AIDS

N/A
Waitlist Available
Led By Robert Sandoval, MS, PT
Research Sponsored by Texas Woman's University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights

Summary

WHAT IS THE PURPOSE OF THIS STUDY? The investigators want to know if wearing a pair of splints at night works to bring the pain down and help you sleep better (in people living with HIV/AIDS related neuropathy). HOW MANY PEOPLE WILL PARTICIPATE? About 58 to 88 people will take part in this study at the Harris County Hospital District (HCHD). WHAT WILL HAPPEN DURING THIS STUDY? As a participant, you will be assigned to one of two treatment groups. In one group, you will be asked to wear leg splints at night and the other you will wear the liners of the splints only. You will be asked to answer questions about how well you sleep, how long you sleep, and about your discomfort at the legs. The researcher will be there to help, but the investigators want you to answer the questions on your own if you can. You will be asked to reach forwards standing next to a wall and to walk for 6 minutes after that. The tests will de done in random order. The sessions will be done at the beginning, at week three and week six. You should finish all of the testing and questionnaires in an hour or less, for a total of three hours over six weeks in the investigators clinic. You will receive instructions on how to use the splints with liners or the liners alone at home. You will be asked to wear them at night only for the next 6 weeks. Finally, the principal investigator will contact you weekly by phone, to discuss issues of comfort and your ability to adhere to the instructions provided.

Eligible Conditions
  • HIV/AIDS
  • Sleep
  • Acquired Immunodeficiency Syndrome
  • Peripheral Neuropathy
  • Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain Scores
Pain Scores at Week 3
Sleep Quality/Quantity Scores (PSQI)
Secondary study objectives
Function-Reach
Function-Walking Distance

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Splinting applicationExperimental Treatment1 Intervention
Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
Group II: Splint liner applicationPlacebo Group1 Intervention
The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Splinting application to the lower extremities
2011
N/A
~50

Find a Location

Who is running the clinical trial?

Texas Woman's UniversityLead Sponsor
87 Previous Clinical Trials
5,858 Total Patients Enrolled
Harris County Hospital DistrictOTHER_GOV
6 Previous Clinical Trials
365 Total Patients Enrolled
DJO IncorporatedIndustry Sponsor
15 Previous Clinical Trials
1,238 Total Patients Enrolled
~3 spots leftby Oct 2025
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