Back to resultsFirefly ANKLE Sprain Study
Primary Purpose
Grade I/II Ankle Sprain
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
firefly
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Grade I/II Ankle Sprain
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years and over
- Referred to physiotherapy for treatment of ankle sprain
- Clinical diagnosed ankle sprain with evidence of swelling
- Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form.
- Able and willing to follow the protocol requirements
Exclusion Criteria:
- Has an ankle sprain grade 3
- Evidence of fracture
- Has a pacemaker
- Chronic Obesity (BMI Index >40kg/m2).
- Pregnancy.
- History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
- Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted
- Not able to fit firefly device
Sites / Locations
- Poole NHS Trust Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
firefly
Control
Arm Description
participants treated with firefly device
Standard of care
Outcomes
Primary Outcome Measures
Oedema lower leg
FAAM ankle function measure
Secondary Outcome Measures
Ankle proprioception - as assessed by the time that the participant can stand on one leg for with their eyes closed, this will be recorded and repeated three times, the average will be taken
VAS Pain score
Adverse event rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02307955
Brief Title
Firefly ANKLE Sprain Study
Official Title
Firefly ANKLE Sprain Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Firstkind Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The device to be tested (fireflyTM) stimulates the common peroneal nerve and causes the foot to twitch, and has been shown to increase blood flow. The device is also indicated for the treatment of oedema. In this study the investigators intend to assess the use of the device as an adjunctive therapy for people recovering from grade 1 and 2 ankle sprains.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grade I/II Ankle Sprain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
firefly
Arm Type
Experimental
Arm Description
participants treated with firefly device
Arm Title
Control
Arm Type
Other
Arm Description
Standard of care
Intervention Type
Device
Intervention Name(s)
firefly
Intervention Type
Other
Intervention Name(s)
Standard of care
Primary Outcome Measure Information:
Title
Oedema lower leg
Time Frame
1 week
Title
FAAM ankle function measure
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Ankle proprioception - as assessed by the time that the participant can stand on one leg for with their eyes closed, this will be recorded and repeated three times, the average will be taken
Time Frame
1 week
Title
VAS Pain score
Time Frame
1 week
Title
Adverse event rate
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years and over
Referred to physiotherapy for treatment of ankle sprain
Clinical diagnosed ankle sprain with evidence of swelling
Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form.
Able and willing to follow the protocol requirements
Exclusion Criteria:
Has an ankle sprain grade 3
Evidence of fracture
Has a pacemaker
Chronic Obesity (BMI Index >40kg/m2).
Pregnancy.
History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted
Not able to fit firefly device
Facility Information:
Facility Name
Poole NHS Trust Hospital
City
Poole
State/Province
Dorset
ZIP/Postal Code
BH15 2BH
Country
United Kingdom
12. IPD Sharing Statement
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Firefly ANKLE Sprain Study
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