A New Cancer Rehabilitation Process for Chemotherapy-Induced Foot Neuropathy Using Orthopedic Devices

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

October 31, 2025

Conditions
PolyneuropathyBreast Cancer
Interventions
DEVICE

Silicone orthosis

"in addition to standard treatment, shoe and insole treatment, a new type of treatment for CIPN is being evaluated, a silicone orthosis.The silicone orthosis consists of a half-sock designed for indoor use.~The participants feet are examined, and the foot shape is scanned barefoot using a three-dimensional foot scanner from Volumental. This is performed to use a basis for manufacturing individual silicone orthoses. Activity measurement with an activity sensor, attached to the thigh with tape, is planned for two weeks after receiving the assistive device.~Participants who receive a silicone orthosis are asked to keep a diary of how much they have used it. The follow-up takes place at the Oncology Department 3-6 weeks after the participant has received the assistive device."

DEVICE

Standard Treatment

"The standard treatment is that patients are provided with customized insoles and shoes. Foot status is recorded during the orthopedic technical assessment at OTA, identifying signs of neuropathy, impaired blood circulation, foot deformities, and skin pathologies. A modified version of the validated D-Foot instrument is used to assess the risk of foot ulcers, especially in diabetic patients. The evaluation also includes lower extremity function, gait abnormalities, and existing footwear and insoles.~Differences in foot anthropometry are compared between scanned foot measurements of the study group and those of a control group representing a female Swedish normal population.~ActivePal is a reliable method for measuring and classifying activity levels. Activity measurement is conducted over two weeks."

Trial Locations (1)

413 45

RECRUITING

Sahlgrenska University Hospital, Gothenburg

All Listed Sponsors
lead

Vastra Gotaland Region

OTHER_GOV