Trauma
Conditions
Keywords
Trauma, Limb reconstruction, Amputation, Functional outcome, Sensing
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Engineering and Physical Sciences Research Council, UK
Imperial College London
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* To have sustained a lower-limb trauma and undergone limb salvage surgery OR amputation with fitting of prosthesis
Exclusion criteria
1. Contralateral (or other) limb impairment 2. 18 \> AGE \> 65 3. Currently a hospital inpatient 4. Psychological disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcome (Consisting of Questionnaire Score, Hamlyn Mobility Score (HMS) Gait/Activities of Daily Living Parameters) | 3 months post-reconstruction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Length of Hospital Stay | Up to length of study (1-2 years) | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reconstruction Those who have undergone limb reconstruction following lower limb trauma | 20 |
| Control Healthy volunteers | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Control | Total | Reconstruction |
|---|---|---|---|
| Age, Continuous | 34.7 Years STANDARD_DEVIATION 12.9 | 36.5 Years STANDARD_DEVIATION 14.3 | 38.3 Years STANDARD_DEVIATION 15.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 10 participants | 30 participants | 20 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 9 Participants | 27 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 10 |
| other Total, other adverse events | 0 / 20 | 0 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 10 |
Outcome results
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.
Time frame: 3 months post-reconstruction
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reconstruction | Functional Outcome (Consisting of Questionnaire Score, Hamlyn Mobility Score (HMS) Gait/Activities of Daily Living Parameters) | 19.7 units on a scale | Standard Deviation 13.9 |
| Control | Functional Outcome (Consisting of Questionnaire Score, Hamlyn Mobility Score (HMS) Gait/Activities of Daily Living Parameters) | 58.2 units on a scale | Standard Deviation 1.6 |
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.
Time frame: Up to length of study (1-2 years)