Impact Of Muscle Vibration On Gait Control

NCT ID: NCT05061238

Last Updated: 2025-11-10

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2025-12-31

Brief Summary

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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

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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

Conditions

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Muscle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type OTHER

Vibrating Device

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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David McCall

Role: CONTACT

Phone: 713) 792-6604

Email: [email protected]

Facility Contacts

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David McCall

Role: primary

Related Links

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http://www.mdanderson.org

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