Lower Limb AmputationSTSTrainerNCT04086069
Sit-to-stand Trainer in Patients After Lower Limb Amputation
A study testing Sit-to-stand trainer in people with Lower Limb Amputation, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial summary
The study will include rehabilitation inpatients after unilateral lower limb amputation who are candidates for walking with a prosthesis. Those in the experimental group will receive training using a sit-to-stand trainer device in addition to standard training of standing-up with the help of a physiotherapist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Sit-to-stand trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSlovenia
- Study dates
- 6 Feb 2019to 30 Aug 2020
- 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 lower-limb amputation
- candidate for walking with a prosthesis
- Montreal Cognitive Assessment (MoCA) test score 26 or more
Who cannot join
- associated neurological or orthopaedic disease
- amputation caused by cancer or injury
- BMI below 18.5 or above 30
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
Official title: Effect of Sit-to-stand Trainer in Patients With Unilateral Lower Limb Amputation on the Ability of Independent Standing up
The study will include rehabilitation inpatients after unilateral lower limb amputation who are candidates for walking with a prosthesis. Those in the experimental group will receive training using a sit-to-stand trainer device in addition to standard training of standing-up with the help of a physiotherapist. Those in the control group will only receive the standard training. The effects of the rehabilitation programme will be assessed using the 30-Second Chair Stand Test before the start of the training and after 10 days of training. For the first five patients from each group who will be able to stand up with the use of hands, detailed kinesiological analysis of standing-up pattern will be performed.
- Conditions
- Lower Limb Amputation
- Being tested
- Sit-to-stand trainer
- Keywords
- unilateral lower-lim amputation, sit-to-stand trainer device, 30-Second Chair Stand Test, kinesiological analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit-to-stand trainerDevice
The sit-to-stand trainer device is an exoskeleton that enables standing-up movement resembling the movement of a healthy person. It consists of three sub-systems: a foldable chair, a lever for body orientation and a triggering mechanism. It includes a support for feet with adjustable height. The device offers partial support to the patient while standing up. The patient will exercise with the device for 10 sessions (one per day), standing up for up to 30 times per session.
| Study group | Role | What they receive |
|---|---|---|
| Standard Training+Sit-to-stand trainer | Experimental | Training using a sit-to-stand trainer device in addition to standard training of standing-up with the help of a physiotherapist Receives: Device: Sit-to-stand trainer |
| Standard Training | No intervention | Standard training of standing-up with the help of a physiotherapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 30-Second Chair Stand Test
The test measures the number of times the participant is able to stand and return to a seated position in a chair in 30 seconds.
Measured: Change from day 0 to day 10
Secondary outcomes (1)
Standing-up pattern
Detailed qualitative kinesiological analysis Will be performed to determine the standing-up pattern.
Measured: On day 10 after the last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start6 Feb 2019
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Why it stopped: Main clinician cancelled collaboration for personal reasons.
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 Lower Limb 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helena Burger, MD, PhD, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086069
- Sponsor's protocol ID
- URIS201903
- Acronym
- STSTrainer
- Status last verified
- Feb 2021
- First submitted
- 5 Sep 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
PubMed 37276273
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sit-to-stand Trainer in Patients With Unilateral Lower Limb Amputation on the Ability of Independent Standing up
- ClinicalTrials.gov ID
- NCT04086069
- Acronym / sponsor ID
- STSTrainer / URIS201903
- Conditions
- Lower Limb Amputation
- Keywords
- unilateral lower-lim amputation, sit-to-stand trainer device, 30-Second Chair Stand Test, kinesiological analysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Main clinician cancelled collaboration for personal reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 11 Sep 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 study will include rehabilitation inpatients after unilateral lower limb amputation who are candidates for walking with a prosthesis. Those in the experimental group will receive training using a sit-to-stand trainer device in addition to standard training of standing-up with the help of a physiotherapist. Those in the control group will only receive the standard training. The effects of the rehabilitation programme will be assessed using the 30-Second Chair Stand Test before the start of the training and after 10 days of training. For the first five patients from each group who will be able to stand up with the use of hands, detailed kinesiological analysis of standing-up pattern will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Training+Sit-to-stand trainer | Experimental | Device: Sit-to-stand trainerTraining using a sit-to-stand trainer device in addition to standard training of standing-up with the help of a physiotherapist |
| Standard Training | No intervention | –Standard training of standing-up with the help of a physiotherapist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- unilateral lower-limb amputation
- candidate for walking with a prosthesis
- Montreal Cognitive Assessment (MoCA) test score 26 or more
Key exclusion criteria (3 listed)
- associated neurological or orthopaedic disease
- amputation caused by cancer or injury
- BMI below 18.5 or above 30
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 |
|---|---|---|
| Sit-to-stand trainerThe sit-to-stand trainer device is an exoskeleton that enables standing-up movement resembling the movement of a healthy person. It consists of three sub-systems: a foldable chair, a lever for body orientation and a triggering mechanism. It includes a support for feet with adjustable height. The device offers partial support to the patient while standing up. The patient will exercise with the device for 10 sessions (one per day), standing up for up to 30 times per session. | Device | Standard Training+Sit-to-stand trainer |
Primary outcome
Change in 30-Second Chair Stand Test
Time frame: Change from day 0 to day 10
The test measures the number of times the participant is able to stand and return to a seated position in a chair in 30 seconds.
1 secondary outcome
Standing-up pattern
Time frame: On day 10 after the last training session
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Derived from this study: PubMed 37276273B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
- 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.
Helena Burger, MD, PhD principal investigator
University Rehabilitation Institute, Republic of Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit-to-stand trainer in people with Lower Limb Amputation, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
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 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: withdrawn, as of the sponsor's last update on 16 Feb 2021. 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 Slovenia. 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 withdrawn before enrolling participants, so there are no results.
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?
Change in 30-Second Chair Stand Test (time frame: Change from day 0 to day 10). 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 NCT04086069, 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 16 Feb 2021.