Muscle
Conditions
Brief summary
This is a single-site interventional open label pilot study of a non-significant risk medical device on patients with defined peripheral neuropathy secondary to chemotherapy (N=10). Patients who have received chemotherapy and have evidence of neuropathy will be seen at MD Anderson. Their severity of neuropathy will be documented and assessed by physical therapy, occupational therapy and based on self-reported activities of daily living (ADL) impairment.
Detailed description
Primary Objective: To assess the effect of a vibrating device applied to selected muscles on the step Secondary Objectives: * To summarize the adverse events of different levels from using the vibrator device in oncologic AYA patients visiting the outpatient clinic. * To summarize the irritation, pain, and sensation of the application of vibration by the AYA patients, as determined by the survey during the application
Interventions
DEVICEVibrating Device
The vibrating device strapped to different parts of your leg. The device will be secured to your leg with a Velcro strap.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Subjects between the ages of 6 and 39 years. * Study subjects, or their parent/legal guardian for subjects \<18 years, must be able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. * History of any type of cancer- * Diagnosed with peripheral neuropathy-associated gait dysfunction as defined by the treating physician. * Able (in the Investigators estimation) and willing to comply with all study requirements. * Subjects must be able to walk; assistance of a walker or similar support apparatus is allowed. * Patients with ankle foot orthosis (AFOs) are allowed but will need to be removed prior to testing.
Exclusion criteria
* Participants with amputations, prosthetics, congenital malformations or any severe lower extremity deformities affecting gait before trials. * Abnormalities of the lower extremities as determined by the investigator. * Unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg). * Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * Other unspecified reasons that, in the opinion of the Investigator make the subject unsuitable for enrolment * Pregnant women * Children \<15 years old * Blind
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the effect of a vibrating device applied to selected muscles on the step times of adolescent or young adult (AYA). | through study completion, an average of 1 year |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid McCall
M.D. Anderson Cancer Center
Outcome results
None listed