Impact Of Muscle Vibration On Gait Control

  • STATUS
    Recruiting
  • End date
    Apr 15, 2022
  • participants needed
    10
  • sponsor
    M.D. Anderson Cancer Center
Updated on 13 October 2021

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.

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

Details
Condition Muscle
Treatment Vibrating Device
Clinical Study IdentifierNCT05061238
SponsorM.D. Anderson Cancer Center
Last Modified on13 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects between the ages of 15 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 without the assistance of a walker or similar support apparatus
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
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