Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy

NACompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
HIVAIDSPeripheral NeuropathyPainSleep
Interventions
DEVICE

Splinting application to the lower extremities

Walkabout™ splints (Don Joy Orthopedics, Vista, CA, USA) will used in the splinting treatment. The Walkabout splint is a one-piece injection molded walking boot fitted with a rocker bottom allowing for ambulation. The participants will be fitted and instructed to wear the bilateral LE splints to sleep for the duration of the study (6 weeks).

DEVICE

Splint liner application

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 (6 weeks).

Trial Locations (1)

77009

Thomas Street Health Center-HCHD, Houston

All Listed Sponsors
collaborator

Harris County Hospital District

OTHER_GOV

collaborator

DJO Incorporated

INDUSTRY

lead

Texas Woman's University

OTHER

NCT01419314 - Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy | Biotech Hunter | Biotech Hunter