Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2021-10-04
2025-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Vibrating Device
you will be asked to walk up and down a hallway 5 times with the vibrating device strapped to different parts of your leg.
Vibrating Device
The vibrating device strapped to different parts of your leg. The device will be secured to your leg with a Velcro strap.
Interventions
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Vibrating Device
The vibrating device strapped to different parts of your leg. The device will be secured to your leg with a Velcro strap.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
39 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David McCall
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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David McCall
Role: primary
Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2021-09935
Identifier Type: OTHER
Identifier Source: secondary_id
2021-0620
Identifier Type: -
Identifier Source: org_study_id