Lower Limb AmputeesNCT02297295
Impact of Exercise Medicine on Lower Limb Amputees According to the International Classification of Functioning
A study testing Physiotherapy in people with Lower Limb Amputees, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The purpose of this study is to determine whether exercise medicine in lower limb amputees has a impact on the three domains of the International Classification of Functioning of the WHO (function, activities and participation), and on quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputees
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2014to Dec 2016
- 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
- amputees with prothesis
- after learning how to walk with the prothesis
- walking with or without technical aids
Who cannot join
- previous exercise training
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Service de médecine physique et réadapation des Cliniques Universitaires Saint-Luc
Brussels, 1200
About this study
Official title: Impact of Exercise Medicine on Lower Limb Amputees According to the Three Domains of the International Classification of Functioning
The purpose of this study is to determine whether exercise medicine in lower limb amputees has a impact on the three domains of the International Classification of Functioning of the WHO (function, activities and participation), and on quality of life.
Read the detailed description
Exercise medicine in lower limb amputees has a positive impact on physical condition and on some cardiovascular aspects (first domain of ICF). But as the investigators know, there is no evidence that this improvement is connected with a significant benefit on the performance of daily live activities and social participation (second and third domains of the ICF).
The investigators want to determine benefits of exercise medicine on all of these domains.
- Conditions
- Lower Limb Amputees
- Being tested
- Physiotherapy
- Keywords
- Sequelae of; Amputation, Traumatic, Limb, Lower
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Physiotherapy three times a week for 8 weeks according to a well-defined protocol
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Experimental | Comparing the patients to themselves (spontaneus evolution) before intervention. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 minutes walk test
Measured: at -1, 0, 2 and 4 mounths
Secondary outcomes (5)
Change in Timed Up and Go
Measured: at -1, 0, 2 and 4 mounths
Change in Satisfaction towards prothesis questionnaire (SAT-PRO)
questionnaire
Measured: at -1, 0, 2 and 4 mounths
Change in Flexibility test
measurement of distance between fingers and floor
Measured: at -1, 0, 2 and 4 mounths
Change in Isokinetic strength testing
Measured: at -1, 0, 2 and 4 mounths
Change in Prosthetic Profile of the Amputee
Measured: at -1, 0, 2 and 4 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb AmputeesStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Caty, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297295
- Sponsor's protocol ID
- EMA001
- Other IDs
- 2014/09AVR/175
- Status last verified
- Nov 2014
- First submitted
- 10 Jul 2014
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise Medicine on Lower Limb Amputees According to the Three Domains of the International Classification of Functioning
- ClinicalTrials.gov ID
- NCT02297295
- Acronym / sponsor ID
- EMA001
- Conditions
- Lower Limb Amputees
- Keywords
- Sequelae of; Amputation, Traumatic, Limb, Lower
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Nov 2014 (estimated)
- 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 purpose of this study is to determine whether exercise medicine in lower limb amputees has a impact on the three domains of the International Classification of Functioning of the WHO (function, activities and participation), and on quality of life.
Detailed description
Exercise medicine in lower limb amputees has a positive impact on physical condition and on some cardiovascular aspects (first domain of ICF). But as the investigators know, there is no evidence that this improvement is connected with a significant benefit on the performance of daily live activities and social participation (second and third domains of the ICF).
The investigators want to determine benefits of exercise medicine on all of these domains.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Experimental | Other: PhysiotherapyComparing the patients to themselves (spontaneus evolution) before intervention. |
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 lower limb amputation
- amputees with prothesis
- after learning how to walk with the prothesis
- walking with or without technical aids
Key exclusion criteria (1 listed)
- previous exercise training
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 |
|---|---|---|
| PhysiotherapyPhysiotherapy three times a week for 8 weeks according to a well-defined protocol | Other | Physiotherapy |
Primary outcome
Change in 6 minutes walk test
Time frame: at -1, 0, 2 and 4 mounths
5 secondary outcomes
Change in Timed Up and Go
Time frame: at -1, 0, 2 and 4 mounths
Change in Satisfaction towards prothesis questionnaire (SAT-PRO)
Time frame: at -1, 0, 2 and 4 mounths
Change in Flexibility test
Time frame: at -1, 0, 2 and 4 mounths
Change in Isokinetic strength testing
Time frame: at -1, 0, 2 and 4 mounths
Change in Prosthetic Profile of the Amputee
Time frame: at -1, 0, 2 and 4 mounths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
Gilles Caty principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Lower Limb Amputees, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 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 17 Nov 2015. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles Caty (003227641650, gilles.caty@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6 minutes walk test (time frame: at -1, 0, 2 and 4 mounths). 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 17 Nov 2015.