Clinical trial NCT05061238: Impact Of Muscle Vibration On Gait Control
Official title: Impact Of Muscle Vibration On Gait Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: To establish the effect of a vibrating device applied to selected muscles on the step times of adolescent or young adult (AYA).
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David McCall
role: PRINCIPAL_INVESTIGATOR
References: