Trial Outcomes & Findings for Investigating Outcomes of Lower Limb Trauma (NCT NCT01691950)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

3 months post-reconstruction

Results posted on

2020-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	Reconstruction Those who have undergone limb reconstruction following lower limb trauma	Control Healthy volunteers
Overall Study STARTED	20	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	10	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reconstruction n=20 Participants Those who have undergone limb reconstruction following lower limb trauma	Control n=10 Participants Healthy volunteers	Total n=30 Participants Total of all reporting groups
Age, Continuous	38.3 Years STANDARD_DEVIATION 15.8 • n=20 Participants	34.7 Years STANDARD_DEVIATION 12.9 • n=10 Participants	36.5 Years STANDARD_DEVIATION 14.3 • n=30 Participants
Sex: Female, Male Female	2 Participants n=20 Participants	1 Participants n=10 Participants	3 Participants n=30 Participants
Sex: Female, Male Male	18 Participants n=20 Participants	9 Participants n=10 Participants	27 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	20 participants n=20 Participants	10 participants n=10 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Reconstruction n=20 Participants Those who have undergone limb reconstruction following lower limb trauma	Control n=10 Participants Healthy volunteers
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	58.2 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Reconstruction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr Richard M Kwasnicki PhD MRCS

Imperial College London

Phone: +44 (0) 20 759 48904

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place