AmputationNCT06168396
Somatosensation Device Trial
A study testing Somatosensation Device and Baseline in people with Amputation and Neuropathy, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
This research is being done to test a new device, called the Somatosensation Device, with people who have either a below knee amputation, or neuropathy (i.e. decreased sensation) in their legs. When people have lost sensation in their feet, it may make walking and balance more difficult. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Amputation, Neuropathy
- What is being tested?
- Somatosensation Device and Baseline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a below-knee amputation (either unilateral or bilateral) or neuropathy in their lower limbs.
- Ability to wear the somatosensation device on their lower limbs
- Ability to wear test equipment and heart rate monitors.
- Ability to follow simple directions.
Who cannot join
- History of severe back pain in the last 3 months.
- History of severe knee pain in the last 3 months.
- Unable to walk for 3 minutes with or without an assistive device
- Poor skin integrity (i.e open wounds, skin breakdown) that could be made worse by wearing the somatosensation device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing of the Somatosensation Device (SD) for Device Effectiveness While Enhancing Feedback in Lower Extremities
This research is being done to test a new device, called the Somatosensation Device, with people who have either a below knee amputation, or neuropathy (i.e. decreased sensation) in their legs. When people have lost sensation in their feet, it may make walking and balance more difficult. The Somatosensation Device is designed to substitute the loss of feeling in a foot by pressing on nerves on the surface of the leg. It presses on the nerves by using a pneumatic balloon to put pressure on your skin. If people receive this extra sensation feedback, it may help improve their walking and balance.
- Conditions
- Amputation, Neuropathy
- Being tested
- Somatosensation Device, Baseline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatosensation DeviceDevice
The somatosensation device will be worn on the lower limb (either the residual limb for an amputee, or limb with decreased sensation for a participant with diabetic neuropathy) while performing outcome measures.
BaselineOther
Participants will perform outcome measures without wearing the somatosensation device.
| Study group | Role | What they receive |
|---|---|---|
| Baseline (Without Somatosensation Device) | Active comparator | Participants will perform all outcome measures without wearing the somatosensation device. Receives: Other: Baseline |
| With Somatosensation Device | Experimental | Participants will perform all outcome measures while wearing the somatosensation device. Receives: Device: Somatosensation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Gait Assessment (FGA)
The Functional Gait Assessment is a test to assess an individual's postural stability and ability to perform multiple motor tasks while walking. Tests include walking at different speeds, walking with head turns, turns, stepping over obstacles, walking tandem, walking with eyes closed, walking backwards, and stair navigation. Scores are on a 0-30 scale, with higher scores showing better balance and mobility.
Measured: Baseline, during the intervention
Secondary outcomes (4)
10 Meter Walk Test
The 10MWT assesses walking speed in meters per second. In the 10MWT, subjects are directed to walk at their self-selected and maximum safe speed with the effects of acceleration and deceleration minimized (by adding 2 meters at the beginning and at the end of the course to isolate the subject's steady state speed). Any assistive device and orthotic should be kept consistent and documented. Participants will complete three trials at their self-selected speed and three trials at their fast but still safe speed. This will be performed over the GAITRite electronic walkway, to measure temporal-spatial gait parameters.
Measured: Baseline, during the intervention
Mini-BESTest
A multi-task balance assessment that identifies postural control problems across a wide variety of situations.
Measured: Baseline, during the intervention
Activities Specific Balance Confidence Scale (ABC)
A self-reported questionnaire that measures a participant's confidence in their balance in performing various activities without falling or becoming unsteady. Scores are on a 0-100% confidence scale, with higher scores equaling greater confidence.
Measured: Baseline, during the intervention
Vestibular Disorders Activities of Daily Living Scale (VADL)
A self-reported questionnaire that evaluates the effects of vertigo and balance disorders on independence routine activities of daily living. Scores range from 1-8, with lower scores indicating greater independence with activities.
Measured: Baseline, during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Mar 2024
- Primary completion30 Apr 2024
- Study completion1 May 2024
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.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168396
- Sponsor's protocol ID
- STU00219855
- Status last verified
- Dec 2024
- First submitted
- 22 Nov 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of the Somatosensation Device (SD) for Device Effectiveness While Enhancing Feedback in Lower Extremities
- ClinicalTrials.gov ID
- NCT06168396
- Acronym / sponsor ID
- STU00219855
- Conditions
- Amputation, Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 13 Dec 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.
This research is being done to test a new device, called the Somatosensation Device, with people who have either a below knee amputation, or neuropathy (i.e. decreased sensation) in their legs. When people have lost sensation in their feet, it may make walking and balance more difficult. The Somatosensation Device is designed to substitute the loss of feeling in a foot by pressing on nerves on the surface of the leg. It presses on the nerves by using a pneumatic balloon to put pressure on your skin. If people receive this extra sensation feedback, it may help improve their walking and balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline (Without Somatosensation Device) | Active comparator | Other: BaselineParticipants will perform all outcome measures without wearing the somatosensation device. |
| With Somatosensation Device | Experimental | Device: Somatosensation DeviceParticipants will perform all outcome measures while wearing the somatosensation device. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a below-knee amputation (either unilateral or bilateral) or neuropathy in their lower limbs.
- Ability to wear the somatosensation device on their lower limbs
- Ability to wear test equipment and heart rate monitors.
- Ability to follow simple directions.
Key exclusion criteria (4 listed)
- History of severe back pain in the last 3 months.
- History of severe knee pain in the last 3 months.
- Unable to walk for 3 minutes with or without an assistive device
- Poor skin integrity (i.e open wounds, skin breakdown) that could be made worse by wearing the somatosensation device.
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 |
|---|---|---|
| Somatosensation DeviceThe somatosensation device will be worn on the lower limb (either the residual limb for an amputee, or limb with decreased sensation for a participant with diabetic neuropathy) while performing outcome measures. | Device | With Somatosensation Device |
| BaselineParticipants will perform outcome measures without wearing the somatosensation device. | Other | Baseline (Without Somatosensation Device) |
Primary outcome
Functional Gait Assessment (FGA)
Time frame: Baseline, during the intervention
The Functional Gait Assessment is a test to assess an individual's postural stability and ability to perform multiple motor tasks while walking. Tests include walking at different speeds, walking with head turns, turns, stepping over obstacles, walking tandem, walking with eyes closed, walking backwards, and stair navigation. Scores are on a 0-30 scale, with higher scores showing better balance and mobility.
4 secondary outcomes
10 Meter Walk Test
Time frame: Baseline, during the intervention
Mini-BESTest
Time frame: Baseline, during the intervention
Activities Specific Balance Confidence Scale (ABC)
Time frame: Baseline, during the intervention
Vestibular Disorders Activities of Daily Living Scale (VADL)
Time frame: Baseline, during the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatosensation Device and Baseline in people with Amputation and Neuropathy, run by Shirley Ryan AbilityLab 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 4 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Gait Assessment (FGA) (time frame: Baseline, during the intervention). 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 4 Dec 2024.