Amputation of Lower Limb Below KneeNCT05895253
Safety and Efficacy of Vibro-tactile Feedback for Patients Who Underwent Lower Limb Amputation
A study testing vibrotactile ground-contact feedback in people with Amputation of Lower Limb Below Knee and Unilateral, run by Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA at 1 site in Austria.
Trial summary
Prosthetics research has grown recently, focusing on bionic approaches that restore bodily functions with technical aids. One method involves using prostheses with feedback systems, which measure physical parameters and provide additional information to the user. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Amputation of Lower Limb Below Knee, Unilateral
- What is being tested?
- vibrotactile ground-contact feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustria
- Study dates
- 25 Oct 2021to 6 May 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male, female, and diverse individuals
- unilateral transtibial amputation
- at least 18 months post surgery
- walking without aids possible
- signed informed consent form
Who cannot join
- insufficient thigh sensation to distinguish between the two closest vibrotactile actuators
- an acute event that restricts the walking ability
- interfering lesions or painful conditions
- undergone targeted re-innervation surgery
- poor stump condition
- used a non-modular prosthesis
Show all 9Show fewer
- used a prosthesis in poor condition
- conditions preventing safe participation or interfering with study objectives
- not able to not comply with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Prosthetics research has grown recently, focusing on bionic approaches that restore bodily functions with technical aids. One method involves using prostheses with feedback systems, which measure physical parameters and provide additional information to the user. Saphenus has developed a feedback system called Suralis© that transfers pressure signals from the prosthetic sole to another body region. This clinical investigation aimed to determine if this system improves gait stability and walking. The study analyzed changes in gait and functional balance and gathered patient-reported measures to evaluate the quality of life.
This research was open to individuals who have undergone below-knee amputation but no targeted re-innervation surgery and use prosthetics. Participants received the Suralis© feedback system, and the investigators assessed their walking activities. The system measures prosthetic foot sole pressure and converts it into digital signals, triggering vibration stimuli during the stance phase of walking. The investigators collected gait analyses and patient feedback to assess the impact of the feedback system on prosthetic management. The results will help us understand the benefits and effectiveness of this technology for people with amputation.
Read the detailed description
The investigators conducted a prospective, unblinded crossover trial to compare the effectiveness of a vibration intervention with no intervention. Participants were randomly assigned to one of two sequences: vibration intervention followed by no intervention or vice versa. The intervention involved using the Suralis© vibrotactile ground-contact feedback system for 60 days. The system transmitted ground contact information to the residual lateral thigh, providing sensory feedback. During the control phase, participants received no additional intervention. The washout period lasted seven days. The study collected data during four visits, assessing gait and patient-reported measures. Bayesian generalized linear mixed models were used for data analysis, considering fixed effects (intervention, sequence, and period) and random effects (individuality).
- Conditions
- Amputation of Lower Limb Below Knee, Unilateral
- Being tested
- vibrotactile ground-contact feedback
- Keywords
- lower limb amputation, somatosensory feedback, functional balance, gait performance, rehabilitation, four square step test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibrotactile ground-contact feedbackDevice
Suralis®, Saphenus Medical Technology (Baden, Lower Austria, Austria)
| Study group | Role | What they receive |
|---|---|---|
| Control-Vibration | Active comparator | Participants were assessed before and after 60 days of no additional intervention to any ongoing treatment, after seven days of washout, and after receiving 60 days of vibrotactile ground-contact feedback. Receives: Device: vibrotactile ground-contact feedback |
| Vibration-Control | Active comparator | Participants were assessed before and after receiving 60 days of vibrotactile ground-contact feedback, after seven days of washout, and after 60 days of no additional intervention to any ongoing treatment. Receives: Device: vibrotactile ground-contact feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affected leg stance time treatment-change difference
Stance time of the prosthetic leg during walking over level ground and on a 518 cm instrumented walkway at a self-selected speed
Measured: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
Secondary outcomes (7)
Gait speed treatment-change difference
Average speed of walking over level ground and on a 518 cm instrumented walkway at a self-selected speed
Measured: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
Unaffected leg step length treatment-change difference
Step length of the non-prosthetic leg during walking over level ground and on a 518 cm instrumented walkway at a self-selected speed
Measured: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
Quality of life score treatment-change difference
EuroQol (EQ) 5-Dimension (5D) 3-Level (3L) version, visual analog scale (VAS)
Measured: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); once each assessment day
Adverse effects frequency treatment difference
Patient diary documentation and interview regarding adverse effects
Measured: Difference in the event frequency during the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V - C; once each assessment day
Timed up and go test time treatment-change difference
Stand up, walk 3 m, turn around, and sit down
Measured: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
2 min walk test distance treatment-change difference
Walking distance in meters within a 2 min time frame
Measured: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); once each assessment day
Four square step test time treatment-change difference
Do and reverse four steps over 90 cm long canes arranged in a cross configuration on the ground
Measured: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start25 Oct 2021
- Primary completion6 May 2022
- Study completion6 May 2022
Why it stopped: recruitment rate of patients was not sufficient during COVID-19; problems with the quality of the primary outcome data collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amputation of Lower Limb Below KneeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
- Sponsor type
- Other government
- Collaborators
- Saphenus Medical Technology GmbH
- Responsible party
- Sponsor
- Investigators
- Gerfried Peternell, MD, Principal investigator, Ludwig Boltzmann Institute for Traumatology, The Research Center in Cooperation with the AUVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895253
- Sponsor's protocol ID
- IPS002
- Status last verified
- Jun 2023
- First submitted
- 19 May 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in the main publication
Publications
Penasso H, Peternell G, Schultheis R, Pitschl A, Leskovar R, Gardetto A, Ernst J, Schmid-Zalaudek K, Schaden W. Safety and efficacy of vibrotactile feedback for adults with transtibial amputation: A randomized controlled cross-over trial. Clin Biomech (Bristol). 2025 Apr;124:106443. doi: 10.1016/j.clinbiomech.2025.106443. Epub 2025 Feb 10.
PubMed 40054381
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Vibro-tactile Feedback for Patients Who Underwent Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT05895253
- Acronym / sponsor ID
- IPS002
- Conditions
- Amputation of Lower Limb Below Knee, Unilateral
- Keywords
- lower limb amputation, somatosensory feedback, functional balance, gait performance, rehabilitation, four square step test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment rate of patients was not sufficient during COVID-19; problems with the quality of the primary outcome data collected
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVAOther government
- Collaborators
- Saphenus Medical Technology GmbH
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 8 Jun 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.
Prosthetics research has grown recently, focusing on bionic approaches that restore bodily functions with technical aids. One method involves using prostheses with feedback systems, which measure physical parameters and provide additional information to the user. Saphenus has developed a feedback system called Suralis© that transfers pressure signals from the prosthetic sole to another body region. This clinical investigation aimed to determine if this system improves gait stability and walking. The study analyzed changes in gait and functional balance and gathered patient-reported measures to evaluate the quality of life.
This research was open to individuals who have undergone below-knee amputation but no targeted re-innervation surgery and use prosthetics. Participants received the Suralis© feedback system, and the investigators assessed their walking activities. The system measures prosthetic foot sole pressure and converts it into digital signals, triggering vibration stimuli during the stance phase of walking. The investigators collected gait analyses and patient feedback to assess the impact of the feedback system on prosthetic management. The results will help us understand the benefits and effectiveness of this technology for people with amputation.
Detailed description
The investigators conducted a prospective, unblinded crossover trial to compare the effectiveness of a vibration intervention with no intervention. Participants were randomly assigned to one of two sequences: vibration intervention followed by no intervention or vice versa. The intervention involved using the Suralis© vibrotactile ground-contact feedback system for 60 days. The system transmitted ground contact information to the residual lateral thigh, providing sensory feedback. During the control phase, participants received no additional intervention. The washout period lasted seven days. The study collected data during four visits, assessing gait and patient-reported measures. Bayesian generalized linear mixed models were used for data analysis, considering fixed effects (intervention, sequence, and period) and random effects (individuality).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-Vibration | Active comparator | Device: vibrotactile ground-contact feedbackParticipants were assessed before and after 60 days of no additional intervention to any ongoing treatment, after seven days of washout, and after receiving 60 days of vibrotactile ground-contact feedback. |
| Vibration-Control | Active comparator | Device: vibrotactile ground-contact feedbackParticipants were assessed before and after receiving 60 days of vibrotactile ground-contact feedback, after seven days of washout, and after 60 days of no additional intervention to any ongoing treatment. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male, female, and diverse individuals
- unilateral transtibial amputation
- at least 18 months post surgery
- walking without aids possible
- signed informed consent form
Key exclusion criteria (9 listed)
- insufficient thigh sensation to distinguish between the two closest vibrotactile actuators
- an acute event that restricts the walking ability
- interfering lesions or painful conditions
- undergone targeted re-innervation surgery
- poor stump condition
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 ground-contact feedbackSuralis®, Saphenus Medical Technology (Baden, Lower Austria, Austria) | Device | Control-Vibration, Vibration-Control |
Primary outcome
Affected leg stance time treatment-change difference
Time frame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
Stance time of the prosthetic leg during walking over level ground and on a 518 cm instrumented walkway at a self-selected speed
7 secondary outcomes
Gait speed treatment-change difference
Time frame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
Unaffected leg step length treatment-change difference
Time frame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
Quality of life score treatment-change difference
Time frame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); once each assessment day
Adverse effects frequency treatment difference
Time frame: Difference in the event frequency during the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V - C; once each assessment day
Timed up and go test time treatment-change difference
Time frame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
2 min walk test distance treatment-change difference
Time frame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); once each assessment day
Four square step test time treatment-change difference
Time frame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
Results and safety
The study was stopped early (reason given: recruitment rate of patients was not sufficient during COVID-19; problems with the quality of the primary outcome data collected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Derived from this study: PubMed 40054381Penasso H, Peternell G, Schultheis R, Pitschl A, Leskovar R, Gardetto A, Ernst J, Schmid-Zalaudek K, Schaden W. Safety and efficacy of vibrotactile feedback for adults with transtibial amputation: A randomized controlled cross-over trial. Clin Biomech (Bristol). 2025 Apr;124:106443. doi: 10.1016/j.clinbiomech.2025.106443. Epub 2025 Feb 10.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in the main publication
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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.
Gerfried Peternell, MD principal investigator
Ludwig Boltzmann Institute for Traumatology, The Research Center in Cooperation with the AUVA
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 ground-contact feedback in people with Amputation of Lower Limb Below Knee and Unilateral, run by Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA at 1 site in Austria.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Jun 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 Austria. 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 was stopped early (reason given: recruitment rate of patients was not sufficient during COVID-19; problems with the quality of the primary outcome data collected). Results are not available in the source record.
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?
Affected leg stance time treatment-change difference (time frame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05895253, which also lists 1 linked publication.
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 13 Jun 2023.