Investigating Outcomes of Lower Limb Trauma
Investigating the Outcomes of Lower-limb Trauma Patients
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 23, 2012
CompletedFirst Posted
Study publicly available on registry
September 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
August 20, 2019
CompletedFebruary 20, 2020
February 1, 2020
2 years
April 23, 2012
February 21, 2019
February 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Participant Length of Hospital Stay
Up to length of study (1-2 years)
Study Arms (2)
Reconstruction
Those who have undergone limb reconstruction following lower limb trauma
Healthy volunteers
Healthy volunteers for control
Eligibility Criteria
Participants who have been treated following lower limb trauma at the Imperial College NHS Trust sites will be recruited for this study.
You may qualify if:
- To have sustained a lower-limb trauma and undergone limb salvage surgery OR amputation with fitting of prosthesis
You may not qualify if:
- Contralateral (or other) limb impairment
- \> AGE \> 65
- Currently a hospital inpatient
- Psychological disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College NHS Trust
London, W2 1NY, United Kingdom
MeSH Terms
Conditions
Limitations and Caveats
The trial recruited 0 patients with prostheses and as such this study arm has been deleted.
Results Point of Contact
- Title
- Mr Richard M Kwasnicki PhD MRCS
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Richard M Kwasnicki, BSc (Hons)
Imperial College London
- PRINCIPAL INVESTIGATOR
Shehan Hettiaratchy, PhD, FRCS
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2012
First Posted
September 25, 2012
Study Start
April 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
February 20, 2020
Results First Posted
August 20, 2019
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share