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Completed

NCT Number: NCT02307955

Firefly ANKLE Sprain Study

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.

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Key information

Conditions

Grade I/II Ankle Sprain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Poole NHS Trust Hospital

Poole, Dorset, BH15 2BH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

firefly

Device

Standard of care

Other

Primary outcomes

  1. Oedema lower leg

    Time frame: 1 week

  2. FAAM ankle function measure

    Time frame: 1 week

Secondary outcomes

  1. 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

  2. VAS Pain score

    Time frame: 1 week

  3. Adverse event rate

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Firstkind Ltd

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2014
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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