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Investigating Lower Limb Trauma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Engineering and Physical Sciences Research Council, UK
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01691950
First received: April 23, 2012
Last updated: October 15, 2013
Last verified: March 2013

April 23, 2012
October 15, 2013
April 2012
February 2014   (final data collection date for primary outcome measure)
Functional outcome (consisting of questionnaire score, Hamlyn Mobility Score (HMS) gait/activities of daily living parameters) [ Time Frame: Single Session (up to 1 hour) ] [ Designated as safety issue: No ]
Participants will be given 3 functional outcome scores from a questionnaire, HMS, and objective kinematic measurements
Functional outcome (consisting of questionnaire score, Functional Mobility Assessment (FMA) score, gait/activities of daily living parameters) [ Time Frame: Single Session (up to 1 hour) ] [ Designated as safety issue: No ]
Participants will be given 3 functional outcome scores from a questionnaire, FMA, and objective kinematic measurements
Complete list of historical versions of study NCT01691950 on ClinicalTrials.gov Archive Site
Participant length of hospital stay, rehabilitation time (if appropriate), and complications. [ Time Frame: Up to length of study (1-2 years) ] [ Designated as safety issue: No ]
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. Complications include those related to the lower limb trauma (no complications are likely to arise from the research study).
Same as current
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Investigating Lower Limb Trauma
Investigating the Outcomes of Lower-limb Trauma Patients

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.

Observational
Observational Model: Cohort
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Non-Probability Sample

Participants who have been treated following lower limb trauma at the Imperial College NHS Trust sites will be recruited for this study.

Trauma
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  • Reconstruction
    Those who have undergone limb reconstruction following lower limb trauma
  • Prosthesis
    Those who have undergone amputation and rehabilitation with a prosthesis following lower limb trauma
  • Control
    Healthy volunteers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
July 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01691950
CRO1934
No
Imperial College London
Imperial College London
Engineering and Physical Sciences Research Council, UK
Principal Investigator: Richard M Kwasnicki, BSc (Hons) Imperial College London
Principal Investigator: Shehan Hettiaratchy, PhD, FRCS Imperial College London
Imperial College London
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP