AmputationPrototestNCT05095805
Weight-bearing Exercise for Trans-tibial Amputees
A study testing additional weight-bearing exercise and standard weight-bearing exercise in people with Amputation, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial summary
A simple weight-bearing exercise has been designed using off-the-shelves devices (Nintendo Wii Balance Board) and centre of pressure (COP) analysis software (Python) for trans-tibial amputees receiving their first 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?
- additional weight-bearing exercise and standard weight-bearing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 14 Oct 2021to 31 Dec 2021
- 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
- trans-tibial amputation,
- fitted with first trans-tibial prosthesis,
- independent mobility for 50m with or without assistive aid,
- Functional Independence Measure (FIM) Stairs locomotion scale ≥ 5,
- ability to follow the instructions, Mini Mental State Examination (MMSE) > 25,
- no severe visual problems, ble to see computer screen,
- willing to participate.
Who cannot join
- bilateral lower limb amputation or any other level of unilateral lower limb amputation,
- not candidates for prosthetic fitting.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
Official title: Weight-bearing Training Exercise May Improve Loading of Trans-tibial Prosthesis and Functional Gait
A simple weight-bearing exercise has been designed using off-the-shelves devices (Nintendo Wii Balance Board) and centre of pressure (COP) analysis software (Python) for trans-tibial amputees receiving their first prosthesis. A pilot randomised control study will be conducted to check the progress with weight-bearing training using COP-based objective measures. Additionally, gait and functional task performance will be assessed by means of clinical test. Participants will be divided into 2 groups: test group (performing additional weight-bearing exercises) and control group (receiving only conventional training for fitting of initial prosthesis).
Read the detailed description
Each patient meeting the inclusion criteria will be randomised to either the test group or the control group. The patients will perform ten training sessions with the initial prosthesis, each session lasting for about 30 minutes, within the period of two weeks. They will be assessed at baseline and after the training program.
- Conditions
- Amputation
- Being tested
- additional weight-bearing exercise, standard weight-bearing exercise
- Keywords
- trans-tibial prosthesis, weight-bearing, balance, centre of pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional weight-bearing exerciseBehavioural
Nintendo Wii Balance Board, real-time visual feedback, weight-bearing assessment by center of pressure
standard weight-bearing exerciseBehavioural
conventional training for fitting of initial prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | additional weight-bearing exercise Receives: Behavioral: additional weight-bearing exercise |
| Control group | Active comparator | standard weight-bearing exercise Receives: Behavioral: standard weight-bearing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in centre of pressure (COP) from baseline
Calculation of COP (transversal plane, symmetry index, lateral, sagittal directions) from 4 pressure sensors built into the balance board
Measured: Assessment at baseline and after two weeks
Change in weight distribution in quiet standing
COP assessment for 20s of quiet standing
Measured: Assessment at baseline and after two weeks
Secondary outcomes (2)
Change in 10m walk test
Measured: Assessment at baseline and after two weeks
Change in L-test
Measured: Assessment at baseline and after two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start14 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Collaborators
- Slovenian Research Agency
- Responsible party
- Sponsor
- Investigators
- Helena Burger, MD, PhD, Study chair, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095805
- Sponsor's protocol ID
- URIS202102
- Acronym
- Prototest
- Status last verified
- Jan 2022
- First submitted
- 14 Oct 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight-bearing Training Exercise May Improve Loading of Trans-tibial Prosthesis and Functional Gait
- ClinicalTrials.gov ID
- NCT05095805
- Acronym / sponsor ID
- Prototest / URIS202102
- Conditions
- Amputation
- Keywords
- trans-tibial prosthesis, weight-bearing, balance, centre of pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Collaborators
- Slovenian Research Agency
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Oct 2021 (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.
A simple weight-bearing exercise has been designed using off-the-shelves devices (Nintendo Wii Balance Board) and centre of pressure (COP) analysis software (Python) for trans-tibial amputees receiving their first prosthesis. A pilot randomised control study will be conducted to check the progress with weight-bearing training using COP-based objective measures. Additionally, gait and functional task performance will be assessed by means of clinical test. Participants will be divided into 2 groups: test group (performing additional weight-bearing exercises) and control group (receiving only conventional training for fitting of initial prosthesis).
Detailed description
Each patient meeting the inclusion criteria will be randomised to either the test group or the control group. The patients will perform ten training sessions with the initial prosthesis, each session lasting for about 30 minutes, within the period of two weeks. They will be assessed at baseline and after the training program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Behavioral: additional weight-bearing exerciseadditional weight-bearing exercise |
| Control group | Active comparator | Behavioral: standard weight-bearing exercisestandard weight-bearing exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- trans-tibial amputation,
- fitted with first trans-tibial prosthesis,
- independent mobility for 50m with or without assistive aid,
- Functional Independence Measure (FIM) Stairs locomotion scale ≥ 5,
- ability to follow the instructions, Mini Mental State Examination (MMSE) > 25,
Key exclusion criteria (2 listed)
- bilateral lower limb amputation or any other level of unilateral lower limb amputation,
- not candidates for prosthetic fitting.
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 |
|---|---|---|
| additional weight-bearing exerciseNintendo Wii Balance Board, real-time visual feedback, weight-bearing assessment by center of pressure | Behavioural | Test group |
| standard weight-bearing exerciseconventional training for fitting of initial prosthesis | Behavioural | Control group |
Primary outcome
Change in centre of pressure (COP) from baseline
Time frame: Assessment at baseline and after two weeks
Calculation of COP (transversal plane, symmetry index, lateral, sagittal directions) from 4 pressure sensors built into the balance board
Change in weight distribution in quiet standing
Time frame: Assessment at baseline and after two weeks
COP assessment for 20s of quiet standing
2 secondary outcomes
Change in 10m walk test
Time frame: Assessment at baseline and after two weeks
Change in L-test
Time frame: Assessment at baseline and after two weeks
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 27 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Amputation
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
Hand Prosthesis Usability and Performance
Amputation
Recruiting
E-Socket, Diagnostic Monitoring
Trans-Tibial Amputation
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Recruiting
Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
Lower Limb Amputation
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 study chair
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 additional weight-bearing exercise and standard weight-bearing exercise in people with 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 7 inclusion and 2 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 27 Jan 2022. 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 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?
Change in centre of pressure (COP) from baseline (time frame: Assessment at baseline and after two weeks). The study lists 2 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 Jan 2022.