AmputationNCT05961072
Vibrotactile Stimulation With Saphenus Device
A study testing Vibrotactile sensory feedback device in people with Amputation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
To determine the benefit of the vvibrotactile sensory feedback device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Vibrotactile sensory feedback device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Major lower limb amputee
- Willing and able to participate
Who cannot join
- Age under 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kyle R Eberlin, MD, 617-643-4902, keberlin@mgh.harvard.edu
About this study
Official title: Vibrotactile Stimulation for Improved Gait and Pain After Major Lower Extremity Amputation Using a Non-invasive Vibration Device
To determine the benefit of the vvibrotactile sensory feedback device.
Read the detailed description
In the United States, approximately 150.000 patients undergo a lower extremity amputation annually. With a high change of developing neuropathic pain, decreased mobility due to the missing limb and therefore depressed mental wellbeing, lower extremity amputations are debilitating the patient on multiple facets. From the usage of non-mechanical prosthetic wear, meaningful improvements have been made in surgical amputee care in the recent decades. Osseointegration, and later regenerative nerve surgical techniques like targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI) have led to major improvements in the mobility of lower limb amputees, by introducing myoeletric prosthetics. Although technological advances have let to improved motoric function and motor control over artificial limbs, sensory feedback is still a very complex aspect of regaining full control over the missing limb. Recently, introduced as a technical variation on TMR, Targeted Sensory Reinnervation is based on reinnervation of a defined skin area by another sensory nerve. Recently, application of vibrotactile feedback, connected to the lower extremity prosthetic socket, has shown promising results in regaining proprioception in the missing limb, resulting in improved walking ability and pain. However, Targeted Sensory Reinnervation (TSR) is a novel surgical technique which is not always possible to perform and not available to every lower extremity amputee. Therefore, this study aims to investigate whether this vibrotactile sensory feedback device improves gait and pain in major lower limb amputee population regardless of whether TSR has been conducted.
- Conditions
- Amputation
- Being tested
- Vibrotactile sensory feedback device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile sensory feedback deviceDevice
The company Saphenus Medical Technology GmbH will provide all of the devices for this study. The non-invasive vibrotactile sensory feedback device consists of 4 vibration -motors, which are placed in a cuff or pant on the patient's residual limb (RL). Furthermore, the system consists of a foot sole with integrated sensors and transmitters. The patient will put the sole of their foot into the shoe of the amputated side.
There are 4 sensors matching the vibration motors - 3 under the forefoot and 1 on the heel - in the foot sole. Depending on whether the patient loads their forefoot or their heel while walking, the assigned vibration motor vibrates on the skin of their RL. The patient will learn which vibration motor is assigned to their forefoot and which to their heel. This gives the patient sensory feedback without having to check with their eyes which part of the prosthetic foot is currently touching the ground.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving the vibrotactile sensory feedback device | Experimental | Patients who have undergone a major lower limb amputation and are receiving the vibrotactile sensory feedback device Receives: Device: Vibrotactile sensory feedback device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Velocity
To investigate the potential effects of vibrotactile stimulation on gait velocity by asking the participant to walk a given distance during gait tests and measuring the velocity during which they walk during this distance. The specific gait test is the 10-meter gait velocity test (meters/second).
Measured: One Year
Measure Endurance
To investigate the potential effects of vibrotactile stimulation on endurance by asking the participant to walk a given distance during the 2 minute walking endurance test (meters).
Measured: One Year
Measure Physical Function
To investigate the potential effects of vibrotactile stimulation on physical function of the patient through the Patient Reported Outcome Measurements Physical function short form 6b. This scale goes from 6-30 where lower numbers mean that the patient is less physically able.
Measured: One Year
Measure User Satisfaction of Function
To investigate the potential effects of vibrotactile stimulation on physical function of the patient through the Orthotics Prosthetics Users Survey satisfaction with device questionnaire after the gait tests. This scale goes from 20-100 where lower numbers indicate easier ability to perform physical activities.
Measured: One Year
Measure Pain Overall
To investigate the potential effects of vibrotactile stimulation on amputation-related pain through patient-reported outcomes such as the Defense and Veterans Pain Rating Scale (DVPRS). This scale goes from 0 (no pain) to a 10 (as bad as it could be, nothing else matters).
Measured: One Year
Measure Pain Interference
To investigate the potential effects of vibrotactile stimulation on amputation-related pain through patient-reported outcomes such as Patient Reported Outcome Measurements Pain Interference Short Form 4a. This scale goes from 4-20 where lower numbers indicate less pain.
Measured: One Year
Measure Pain Intensity
To investigate the potential effects of vibrotactile stimulation on amputation-related pain through patient-reported outcomes such as Patient Reported Outcome Measurements Pain Intensity Short Form 3a. This scale goes from 3-15 where lower numbers indicate less pain.
Measured: One Year
Secondary outcomes (3)
Measure Patient Satisfaction
To investigate the potential effects of vibrotactile stimulation on patient satisfaction and mental wellbeing in major lower limb amputees. This will be done through the patient-reported outcomes questionnaire Orthotics Prosthetics Users Survey satisfaction with device. This scale goes from 1-100 where lower numbers indicate easier ability to perform physical activities.
Measured: One Year
Measure Patient Depression
To investigate the potential effects of vibrotactile stimulation on patient satisfaction and mental wellbeing in major lower limb amputees. This will be done through the Patient Reported Outcome Measurements Depression Short Form 4a. This scale goes from 4-20 where lower numbers indicate less depression.
Measured: One Year
Measure Patient Anxiety
To investigate the potential effects of vibrotactile stimulation on patient satisfaction and mental wellbeing in major lower limb amputees. This will be done through the Patient Reported Outcome Measurements Anxiety Short Form 4a. This scale goes from 4-20 where lower numbers indicate less anxiety.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle R. Eberlin, MD, Massachusetts General Hospital
- Investigators
- Kyle R Eberlin, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961072
- Sponsor's protocol ID
- 2023P001047
- Status last verified
- Jul 2023
- First submitted
- 30 May 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrotactile Stimulation for Improved Gait and Pain After Major Lower Extremity Amputation Using a Non-invasive Vibration Device
- ClinicalTrials.gov ID
- NCT05961072
- Acronym / sponsor ID
- 2023P001047
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 27 Jul 2023 (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.
To determine the benefit of the vvibrotactile sensory feedback device.
Detailed description
In the United States, approximately 150.000 patients undergo a lower extremity amputation annually. With a high change of developing neuropathic pain, decreased mobility due to the missing limb and therefore depressed mental wellbeing, lower extremity amputations are debilitating the patient on multiple facets. From the usage of non-mechanical prosthetic wear, meaningful improvements have been made in surgical amputee care in the recent decades. Osseointegration, and later regenerative nerve surgical techniques like targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI) have led to major improvements in the mobility of lower limb amputees, by introducing myoeletric prosthetics. Although technological advances have let to improved motoric function and motor control over artificial limbs, sensory feedback is still a very complex aspect of regaining full control over the missing limb. Recently, introduced as a technical variation on TMR, Targeted Sensory Reinnervation is based on reinnervation of a defined skin area by another sensory nerve. Recently, application of vibrotactile feedback, connected to the lower extremity prosthetic socket, has shown promising results in regaining proprioception in the missing limb, resulting in improved walking ability and pain. However, Targeted Sensory Reinnervation (TSR) is a novel surgical technique which is not always possible to perform and not available to every lower extremity amputee. Therefore, this study aims to investigate whether this vibrotactile sensory feedback device improves gait and pain in major lower limb amputee population regardless of whether TSR has been conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving the vibrotactile sensory feedback device | Experimental | Device: Vibrotactile sensory feedback devicePatients who have undergone a major lower limb amputation and are receiving the vibrotactile sensory feedback device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Major lower limb amputee
- Willing and able to participate
Key exclusion criteria (1 listed)
- Age under 18
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 |
|---|---|---|
| Vibrotactile sensory feedback deviceThe company Saphenus Medical Technology GmbH will provide all of the devices for this study. The non-invasive vibrotactile sensory feedback device consists of 4 vibration -motors, which are placed in a cuff or pant on the patient's residual limb (RL). Furthermore, the system consists of a foot sole with integrated sensors and transmitters. The patient will put the sole of their foot into the shoe of the amputated side. There are 4 sensors matching the vibration motors - 3 under the forefoot and 1 on the heel - in the foot sole. Depending on whether the patient loads their forefoot or their heel while walking, the assigned vibration motor vibrates on the skin of their RL. The patient will learn which vibration motor is assigned to their forefoot and which to their heel. This gives the patient sensory feedback without having to check with their eyes which part of the prosthetic foot is currently touching the ground. | Device | Patients receiving the vibrotactile sensory feedback device |
Primary outcome
Measure Velocity
Time frame: One Year
To investigate the potential effects of vibrotactile stimulation on gait velocity by asking the participant to walk a given distance during gait tests and measuring the velocity during which they walk during this distance. The specific gait test is the 10-meter gait velocity test (meters/second).
Measure Endurance
Time frame: One Year
To investigate the potential effects of vibrotactile stimulation on endurance by asking the participant to walk a given distance during the 2 minute walking endurance test (meters).
Measure Physical Function
Time frame: One Year
To investigate the potential effects of vibrotactile stimulation on physical function of the patient through the Patient Reported Outcome Measurements Physical function short form 6b. This scale goes from 6-30 where lower numbers mean that the patient is less physically able.
Measure User Satisfaction of Function
Time frame: One Year
To investigate the potential effects of vibrotactile stimulation on physical function of the patient through the Orthotics Prosthetics Users Survey satisfaction with device questionnaire after the gait tests. This scale goes from 20-100 where lower numbers indicate easier ability to perform physical activities.
Measure Pain Overall
Time frame: One Year
To investigate the potential effects of vibrotactile stimulation on amputation-related pain through patient-reported outcomes such as the Defense and Veterans Pain Rating Scale (DVPRS). This scale goes from 0 (no pain) to a 10 (as bad as it could be, nothing else matters).
Measure Pain Interference
Time frame: One Year
To investigate the potential effects of vibrotactile stimulation on amputation-related pain through patient-reported outcomes such as Patient Reported Outcome Measurements Pain Interference Short Form 4a. This scale goes from 4-20 where lower numbers indicate less pain.
Measure Pain Intensity
Time frame: One Year
To investigate the potential effects of vibrotactile stimulation on amputation-related pain through patient-reported outcomes such as Patient Reported Outcome Measurements Pain Intensity Short Form 3a. This scale goes from 3-15 where lower numbers indicate less pain.
3 secondary outcomes
Measure Patient Satisfaction
Time frame: One Year
Measure Patient Depression
Time frame: One Year
Measure Patient Anxiety
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Kyle R Eberlin, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile sensory feedback device in people with Amputation, run by Massachusetts General Hospital 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyle R Eberlin, MD ((617) 643-4902, keberlin@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Velocity (time frame: One Year). The study lists 7 primary outcomes in all. 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 27 Jul 2023.