Lower Leg AmputationsProMobNCT04904003
Prosthetic Use, Mobility and Daily Functioning
A study testing Rehabilitation Intervention in people with Lower Leg Amputations, run by Oslo Metropolitan University at 2 sites in Norway.
Trial summary
The goal of the project is to explore which elements of rehabilitation that influence mobility in new and experienced unilateral lower-limb amputees. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Leg Amputations
- What is being tested?
- Rehabilitation Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesNorway
- Study dates
- 9 Apr 2021to 15 Jun 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
- Unilaterally amputated (above the ankle joint / under the hip joint)
- No prior record of use of prosthesis
- Participation approved by physician
Who cannot join
- Bilaterally amputated over ankle joint
- Lack of understanding of Norwegian language (oral, written)
- Neurological disorders affecting gait function
- Skin lesion or abrasion on the stump or remaining extremity affecting mobility and function
- Other issues that complicate participation in a rehabilitation intervention
Trial locations and contacts
2 sites in 1 country.
About this study
The goal of the project is to explore which elements of rehabilitation that influence mobility in new and experienced unilateral lower-limb amputees.
Read the detailed description
Both new and experienced unilateral lower limb amputees (LLA) describe difficulties when ambulating intentionally and independently from one place to another using prosthesis. In LLA, this decreased ability to mobilize affect daily functioning and may result in low activity-levels, impeded social participation and reduced health-related quality of life.
Both primary and secondary rehabilitation of LLA have implications for functional mobility. The consensus among health professionals is that LLA should train to improve their ability to ambulate. However, knowledge from research regarding which elements that constitute effective training and how systematic exercise affects body structures, functions, activity and participation in lower limb amputees, is limited.
There also is a lack of knowledge of how prosthetic users endure and process the challenges regarding mobility, how they adapt to the use of their prosthesis, how safe they are ambulating using the prosthesis, and how pain and psychosocial issues affect their perceived health and mobility.
The aim of this Ph.D.-project is to explore how a period of semi-standardized individualized rehabilitation originating from an evidence-based approach, affect the functional mobility of both new and experienced LLA, and how LLA process the loss of a limb and challenges during ambulation.
- Conditions
- Lower Leg Amputations
- Being tested
- Rehabilitation Intervention
- Keywords
- Rehabilitation, Prosthetic mobility, Outcome measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation InterventionOther
Strength, flexibility, endurance, balance, mobility, (self-efficacy)
| Study group | Role | What they receive |
|---|---|---|
| Experienced LLA - intervention | Experimental | Experienced lower-limb amputees that complete a 4-week semi-structured individualized rehabilitation regime with extensive testing before and after the intervention. Receives: Other: Rehabilitation Intervention |
| Experienced LLA - controls | Experimental | Experienced lower-limb amputees that will be tested with a 4-week interval. No intervention. This group will be matched to the group of experienced lower-limb amputees. Receives: Other: Rehabilitation Intervention |
| New LLA learning to use prosthesis | Experimental | New lower-limb amputees that complete a 8-11 weeks semi-structured individualized rehabilitation regime with extensive testing before and after the intervention. Receives: Other: Rehabilitation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic Limb Users Survey of Mobility (Plus-M) Short form - 12 items
A questionnaire that measures different aspects of mobility in lower-limb amputees (LLA) using prosthesis. PLUS-M provide a score range from 17.5 to 76.6. High scores indicate better outcome.
Measured: 4-8 weeks
The Amputee Mobility Predictor (AMP).
The test is designed to measure mobility and ability to move with prosthesis (AMPPro) and without prosthesis (AMPNoPro). AMPPro provide a score range from 0-47. AMPNoPro provide a score range from 0-43. High scores indicate better outcome.
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start9 Apr 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Leg AmputationsStudies 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
- Model description
- One explorative group, one intervention group and one control group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Sophies Minde Ortopedi, UniCare Bakke AS
- Responsible party
- Sponsor
- Investigators
- Terje Gjøvaag, PhD., Study director, Associate professor and Head of research group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904003
- Sponsor's protocol ID
- 2018/2577
- Acronym
- ProMob
- Status last verified
- Jun 2022
- First submitted
- 5 May 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available. The GDPR-regulations make sharing of research data both time-consuming and difficult.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Use, Mobility and Daily Functioning
- ClinicalTrials.gov ID
- NCT04904003
- Acronym / sponsor ID
- ProMob / 2018/2577
- Conditions
- Lower Leg Amputations
- Keywords
- Rehabilitation, Prosthetic mobility, Outcome measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Sophies Minde Ortopedi, UniCare Bakke AS
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 27 May 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.
The goal of the project is to explore which elements of rehabilitation that influence mobility in new and experienced unilateral lower-limb amputees.
Detailed description
Both new and experienced unilateral lower limb amputees (LLA) describe difficulties when ambulating intentionally and independently from one place to another using prosthesis. In LLA, this decreased ability to mobilize affect daily functioning and may result in low activity-levels, impeded social participation and reduced health-related quality of life.
Both primary and secondary rehabilitation of LLA have implications for functional mobility. The consensus among health professionals is that LLA should train to improve their ability to ambulate. However, knowledge from research regarding which elements that constitute effective training and how systematic exercise affects body structures, functions, activity and participation in lower limb amputees, is limited.
There also is a lack of knowledge of how prosthetic users endure and process the challenges regarding mobility, how they adapt to the use of their prosthesis, how safe they are ambulating using the prosthesis, and how pain and psychosocial issues affect their perceived health and mobility.
The aim of this Ph.D.-project is to explore how a period of semi-standardized individualized rehabilitation originating from an evidence-based approach, affect the functional mobility of both new and experienced LLA, and how LLA process the loss of a limb and challenges during ambulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- One explorative group, one intervention group and one control group
| Arm | Type | Receives |
|---|---|---|
| Experienced LLA - intervention | Experimental | Other: Rehabilitation InterventionExperienced lower-limb amputees that complete a 4-week semi-structured individualized rehabilitation regime with extensive testing before and after the intervention. |
| Experienced LLA - controls | Experimental | Other: Rehabilitation InterventionExperienced lower-limb amputees that will be tested with a 4-week interval. No intervention. This group will be matched to the group of experienced lower-limb amputees. |
| New LLA learning to use prosthesis | Experimental | Other: Rehabilitation InterventionNew lower-limb amputees that complete a 8-11 weeks semi-structured individualized rehabilitation regime with extensive testing before and after the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilaterally amputated (above the ankle joint / under the hip joint)
- No prior record of use of prosthesis
- Participation approved by physician
Key exclusion criteria (5 listed)
- Bilaterally amputated over ankle joint
- Lack of understanding of Norwegian language (oral, written)
- Neurological disorders affecting gait function
- Skin lesion or abrasion on the stump or remaining extremity affecting mobility and function
- Other issues that complicate participation in a rehabilitation intervention
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 |
|---|---|---|
| Rehabilitation InterventionStrength, flexibility, endurance, balance, mobility, (self-efficacy) | Other | Experienced LLA - controls, Experienced LLA - intervention, New LLA learning to use prosthesis |
Primary outcome
Prosthetic Limb Users Survey of Mobility (Plus-M) Short form - 12 items
Time frame: 4-8 weeks
A questionnaire that measures different aspects of mobility in lower-limb amputees (LLA) using prosthesis. PLUS-M provide a score range from 17.5 to 76.6. High scores indicate better outcome.
The Amputee Mobility Predictor (AMP).
Time frame: 4-8 weeks
The test is designed to measure mobility and ability to move with prosthesis (AMPPro) and without prosthesis (AMPNoPro). AMPPro provide a score range from 0-47. AMPNoPro provide a score range from 0-43. High scores indicate better outcome.
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 12 Oct 2022.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available. The GDPR-regulations make sharing of research data both time-consuming and difficult.
Related trials for Lower Leg Amputations
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Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
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Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
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Prosthetic Socket Fit Testing System
Amputation
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TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
RecruitingObservational study
Core Muscle Function and Postural Control in Lower Extremity Amputees
Amputation, Ultrasonography
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.
Terje Gjøvaag, PhD. study director
Associate professor and Head of research group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation Intervention in people with Lower Leg Amputations, run by Oslo Metropolitan University at 2 sites in Norway.
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 5 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 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Prosthetic Limb Users Survey of Mobility (Plus-M) Short form - 12 items (time frame: 4-8 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 12 Oct 2022.