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| Name | Class |
|---|---|
| Engineering and Physical Sciences Research Council, UK | OTHER |
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This is an observational study, which aims to firstly develop a sensor-based objective mobility assessment. This will then be used to profile and compare the outcomes of patients who undergo amputation with those who have limb salvage surgery following a traumatic injury to their lower limb.
In the setting of severe trauma, the decision whether to amputate or save a limb is common, and extremely difficult to make. Due to improving reconstructive surgical techniques there are currently no clear criteria for amputation. Although limb salvage appears desirable in most situations, numerous articles in the scientific literature have shown that it is associated with increased pain, complications, duration of hospital stay, rehabilitation time, and overall costs. These factors may be acceptable if the patients benefited from improved functional outcome. However, studies comparing amputation to limb salvage consistently report no significant difference in functional outcome between the two groups.
A major limitation in the methodology of the fore mentioned studies is the use of self-reported questionnaires to determine functional outcome. Questionnaires are subjective, and often lack specificity, and therefore may not be truly representative of functional outcome. Furthermore, lack of useful information during long-term post-operative care prevents adaption and optimisation of rehabilitation strategies.
The investigators plan on using a wearable sensor to develop an objective mobility assessment tool for patients having either amputation or limb salvage surgery after lower limb trauma. This would result in a reliable and accurate comparison, which may help healthcare professionals make an informed decision between amputation and limb salvage in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reconstruction | Those who have undergone limb reconstruction following lower limb trauma | ||
| Healthy volunteers | Healthy volunteers for control |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional Outcome (Consisting of Questionnaire Score, Hamlyn Mobility Score (HMS) Gait/Activities of Daily Living Parameters) | The Hamlyn Mobility Score is a measure of functional mobility as measured by a wearable sensors during simple physical activities. The score range is from 0 - 60, with 60 being the best score possible and represents normal physical function of a healthy adult. | 3 months post-reconstruction |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Length of Hospital Stay | These measurements refer to the participants healthcare journey (which are not affected by the research project). Hospital stay refers to the time around their lower limb trauma and any further admissions. | Up to length of study (1-2 years) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who have been treated following lower limb trauma at the Imperial College NHS Trust sites will be recruited for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Richard M Kwasnicki, BSc (Hons) | Imperial College London | Principal Investigator |
| Shehan Hettiaratchy, PhD, FRCS | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College NHS Trust | London | W2 1NY | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reconstruction | Those who have undergone limb reconstruction following lower limb trauma |
| FG001 | Control | Healthy volunteers |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reconstruction | Those who have undergone limb reconstruction following lower limb trauma |
| BG001 | Control | Healthy volunteers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Functional Outcome (Consisting of Questionnaire Score, Hamlyn Mobility Score (HMS) Gait/Activities of Daily Living Parameters) | The Hamlyn Mobility Score is a measure of functional mobility as measured by a wearable sensors during simple physical activities. The score range is from 0 - 60, with 60 being the best score possible and represents normal physical function of a healthy adult. | Posted | Mean | Standard Deviation | units on a scale | 3 months post-reconstruction |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reconstruction | Those who have undergone limb reconstruction following lower limb trauma |
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The trial recruited 0 patients with prostheses and as such this study arm has been deleted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Richard M Kwasnicki PhD MRCS | Imperial College London | +44 (0) 20 759 48904 | rmk107@ic.ac.uk |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
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| Secondary | Participant Length of Hospital Stay | These measurements refer to the participants healthcare journey (which are not affected by the research project). Hospital stay refers to the time around their lower limb trauma and any further admissions. | Not Posted | Up to length of study (1-2 years) | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control | Healthy volunteers | 0 | 10 | 0 | 10 | 0 | 10 |
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