MuscleNCT05061238
Impact Of Muscle Vibration On Gait Control
A study testing Vibrating Device in people with Muscle, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 39 years
- Conditions the study is for
- Muscle
- What is being tested?
- Vibrating Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Muscle
- Being tested
- Vibrating Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating DeviceDevice
The vibrating device strapped to different parts of your leg. The device will be secured to your leg with a Velcro strap.
| Study group | Role | What they receive |
|---|---|---|
| Vibrating Device | Other | you will be asked to walk up and down a hallway 5 times with the vibrating device strapped to different parts of your leg. Receives: Device: Vibrating Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the effect of a vibrating device applied to selected muscles on the step times of adolescent or young adult (AYA).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start4 Oct 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MuscleStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David McCall, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061238
- Sponsor's protocol ID
- 2021-0620
- Other IDs
- NCI-2021-09935
- Status last verified
- Jun 2026
- First submitted
- 16 Sep 2021
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Muscle Vibration On Gait Control
- ClinicalTrials.gov ID
- NCT05061238
- Acronym / sponsor ID
- 2021-0620
- Conditions
- Muscle
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrating Device | Other | Device: Vibrating Deviceyou will be asked to walk up and down a hallway 5 times with the vibrating device strapped to different parts of your leg. |
Who may qualify
- Ages
- 6 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrating DeviceThe vibrating device strapped to different parts of your leg. The device will be secured to your leg with a Velcro strap. | Device | Vibrating Device |
Primary outcome
To establish the effect of a vibrating device applied to selected muscles on the step times of adolescent or young adult (AYA).
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David McCall principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrating Device in people with Muscle, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the effect of a vibrating device applied to selected muscles on the step times of adolescent or young adult (AYA). (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.