Firefly ANKLE Sprain Study

Firstkind Ltd24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Grade I/II Ankle Sprain

Interventions

fireflyDEVICE

Standard of careOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18 years and over 2. Referred to physiotherapy for treatment of ankle sprain 3. Clinical diagnosed ankle sprain with evidence of swelling 4. Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form. 5. Able and willing to follow the protocol requirements Exclusion Criteria: 1. Has an ankle sprain grade 3 2. Evidence of fracture 3. Has a pacemaker 4. Chronic Obesity (BMI Index \>40kg/m2). 5. Pregnancy. 6. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism. 7. Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted 8. Not able to fit firefly device

Locations (1)

Poole NHS Trust Hospital

Poole, Dorset, United Kingdom

Outcomes

Primary Outcomes

Oedema lower leg

Time frame: 1 week

FAAM ankle function measure

Time frame: 1 week

Secondary Outcomes

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

VAS Pain score

Time frame: 1 week

Adverse event rate

Time frame: 1 week

Data from ClinicalTrials.gov

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