AmputationNCT03965663
Vibro-tactile Pressure Feedback of the Prosthetic Foot for Trans-tibial Amputees
A study testing Vibro-tactile Feedback in people with Amputation, run by Agnes Sturma.
Trial summary
The aim of the study is to investigate the influence of a vibro-tactile device on trans-tibial amputees in terms of gait, pain and perception of the prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Vibro-tactile Feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Mar 2022
- 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
- unilateral trans-tibial amputation
- uses a prostheses already for more than 1 year
- sufficient touch sensitivity at the stump
- unimpaired contralateral lower extremity
Who cannot join
- psychiatric disorder
- cognitive restrictions
- pregnant or breast feeding women
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the study is to investigate the influence of a vibro-tactile device on trans-tibial amputees in terms of gait, pain and perception of the prosthesis.
Read the detailed description
The study is divided into three phases. The initial phase lasts 6 to 8 weeks for each subject. For subjects of group 2 the length of the initial phase depends on the progression of the re-innervation. The initial phase ends, when the subject can perceive the tactile stimulate at the re-innervated area of the skin. During the initial phase, all subjects get a new prosthesis. To minimize the adjusting to the new prosthesis only a new socket, which houses the vibro-tactile Feedback system, is fabricated and the old prosthetic food is re-used. After a period of 3 weeks minimum, where the subjects use the new prosthesis, a gait analysis and an assessment of the sensitivity of the skin at the stump are performed.
Subsequently the intervention phase starts and the vibro-tactile feedback system is activated. For a period of 6 months the subjects use the new prostheses with the integrated vibro-tactile feedback system in daily living. After 2 and 4 months, the subjects visit the study site for an assessment of the sensitivity of the skin. After 6 months a second gait analysis and an other assessment of the sensitivity of the skin a the stump are performed. Afterwards the vibro-tactile feedback-system is disabled.
During the observing phase the subjects use the prosthesis with the disabled vibro-tactile feedback system for 4 months.
During all three phases the subjects answer the questionnaires every 2 months.
- Conditions
- Amputation
- Being tested
- Vibro-tactile Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibro-tactile FeedbackDevice
The device measures the force between the prosthetic food and the ground. With this signals, vibratators are triggered. The vibrators are housed by the prosthetic socket and stimulate the stump.
| Study group | Role | What they receive |
|---|---|---|
| Trans-tibial Amputees | Experimental | Unilateral Trans-tibial Amputees that use vibro-tactile feedback for six months in daily living Receives: Device: Vibro-tactile Feedback |
| Trans-tibial Amputees with TSR | Experimental | Unilateral Trans-tibial Amputees that use vibro-tactile feedback for six months in daily living. The subjects underwent a functional nerv-transfer surgery prior to participation, where the proximal part of the sural nerv was to the distal part of the saphenous nerv. Receives: Device: Vibro-tactile Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R)
The Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R) is a multidimensional instrument designed to examine the psychosocial processes involved in adjusting to amputation and a prosthesis. TAPES consists of 9 subscales, with possible scores depending on the single subscale. The range is from 0-12 to 0-25 (depending on the number of items and answer possibilities).
Measured: 1 year
Secondary outcomes (6)
Fall Efficacy Scale International Version (FES-I)
The Fall Efficacy Scale International Version (FES-I) is a questionaire that assesses the fear of falling. Scores can range from 16-64, with a higher score indicating a higher fear of falling.
Measured: 1 year
Pain Visual analoge scale (VAS)
The pain is measured with a Visual analoge scale form 0 to 10. O indicates no pain, while 10 is the worst pain the person can imagine.
Measured: 1 year
Number of falls within the last two months
Subjects report the number a falls within the last two months.
Measured: 1 Year
Gait parameters
Two gait analysis are performed with a 3D video-based marker system. Standard gait parameters (as cardence, speed, step length and weight) as well as kinematic and kinetic parameters are calculated.
Measured: 6 months
two point discrimination
the two point discrimination (in mm) at the skin of the stump is assessed
Measured: 6 months
touch perception threshold
the touch percertion at the skin of the stump is assessed with mono filaments
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study startJul 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agnes Sturma
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences Upper Austria
- Responsible party
- Sponsor-investigator, Agnes Sturma, Medical University of Vienna
- Investigators
- Agnes Sturma, MSc, Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965663
- Sponsor's protocol ID
- 2238/2017
- Status last verified
- Jun 2020
- First submitted
- 24 May 2019
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD from the mentioned outcome parameters are planned to be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibro-tactile Pressure Feedback of the Prosthetic Foot for Trans-tibial Amputees
- ClinicalTrials.gov ID
- NCT03965663
- Acronym / sponsor ID
- 2238/2017
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Agnes SturmaUniversity, hospital or other
- Collaborators
- University of Applied Sciences Upper Austria
- Study start
- Jul 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 29 May 2019 (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.
The aim of the study is to investigate the influence of a vibro-tactile device on trans-tibial amputees in terms of gait, pain and perception of the prosthesis.
Detailed description
The study is divided into three phases. The initial phase lasts 6 to 8 weeks for each subject. For subjects of group 2 the length of the initial phase depends on the progression of the re-innervation. The initial phase ends, when the subject can perceive the tactile stimulate at the re-innervated area of the skin. During the initial phase, all subjects get a new prosthesis. To minimize the adjusting to the new prosthesis only a new socket, which houses the vibro-tactile Feedback system, is fabricated and the old prosthetic food is re-used. After a period of 3 weeks minimum, where the subjects use the new prosthesis, a gait analysis and an assessment of the sensitivity of the skin at the stump are performed.
Subsequently the intervention phase starts and the vibro-tactile feedback system is activated. For a period of 6 months the subjects use the new prostheses with the integrated vibro-tactile feedback system in daily living. After 2 and 4 months, the subjects visit the study site for an assessment of the sensitivity of the skin. After 6 months a second gait analysis and an other assessment of the sensitivity of the skin a the stump are performed. Afterwards the vibro-tactile feedback-system is disabled.
During the observing phase the subjects use the prosthesis with the disabled vibro-tactile feedback system for 4 months.
During all three phases the subjects answer the questionnaires every 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans-tibial Amputees | Experimental | Device: Vibro-tactile FeedbackUnilateral Trans-tibial Amputees that use vibro-tactile feedback for six months in daily living |
| Trans-tibial Amputees with TSR | Experimental | Device: Vibro-tactile FeedbackUnilateral Trans-tibial Amputees that use vibro-tactile feedback for six months in daily living. The subjects underwent a functional nerv-transfer surgery prior to participation, where the proximal part of the sural nerv was to the distal part of the saphenous nerv. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral trans-tibial amputation
- uses a prostheses already for more than 1 year
- sufficient touch sensitivity at the stump
- unimpaired contralateral lower extremity
Key exclusion criteria (3 listed)
- psychiatric disorder
- cognitive restrictions
- pregnant or breast feeding women
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 |
|---|---|---|
| Vibro-tactile FeedbackThe device measures the force between the prosthetic food and the ground. With this signals, vibratators are triggered. The vibrators are housed by the prosthetic socket and stimulate the stump. | Device | Trans-tibial Amputees, Trans-tibial Amputees with TSR |
Primary outcome
Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R)
Time frame: 1 year
The Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R) is a multidimensional instrument designed to examine the psychosocial processes involved in adjusting to amputation and a prosthesis. TAPES consists of 9 subscales, with possible scores depending on the single subscale. The range is from 0-12 to 0-25 (depending on the number of items and answer possibilities).
6 secondary outcomes
Fall Efficacy Scale International Version (FES-I)
Time frame: 1 year
Pain Visual analoge scale (VAS)
Time frame: 1 year
Number of falls within the last two months
Time frame: 1 Year
Gait parameters
Time frame: 6 months
two point discrimination
Time frame: 6 months
touch perception threshold
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Individual participant dataSharing planned: Yes. All IPD from the mentioned outcome parameters are planned to be made available to other researchers.
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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.
Agnes Sturma, MSc study director
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
A study testing Vibro-tactile Feedback in people with Amputation, run by Agnes Sturma.
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 3 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 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Agnes Sturma, MSc (+43140400 ext. 61098, agnes.sturma@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R) (time frame: 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 1 Jul 2020.