Firefly ANKLE Sprain Study

March 8, 2016 updated by: Firstkind Ltd
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Dorset
      • Poole, Dorset, United Kingdom, BH15 2BH
        • Poole NHS Trust Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Standard of care
Other: Standard of care
Experimental: firefly
participants treated with firefly device
Device: firefly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oedema lower leg
Time Frame: 1 week
1 week
FAAM ankle function measure
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 week
VAS Pain score
Time Frame: 1 week
1 week
Adverse event rate
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firstkind Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKD-ffANK-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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