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Firefly ANKLE Sprain Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02307955
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : March 9, 2016
Information provided by (Responsible Party):
Firstkind Ltd

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.

Condition or disease Intervention/treatment Phase
Grade I/II Ankle Sprain Device: firefly Other: Standard of care Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Firefly ANKLE Sprain Study
Study Start Date : September 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: firefly
participants treated with firefly device
Device: firefly
Standard of care
Other: Standard of care

Primary Outcome Measures :
  1. Oedema lower leg [ Time Frame: 1 week ]
  2. FAAM ankle function measure [ Time Frame: 1 week ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02307955

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United Kingdom
Poole NHS Trust Hospital
Poole, Dorset, United Kingdom, BH15 2BH
Sponsors and Collaborators
Firstkind Ltd

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Responsible Party: Firstkind Ltd Identifier: NCT02307955     History of Changes
Other Study ID Numbers: FKD-ffANK-001
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs