Firefly ANKLE Sprain Study

NCT ID: NCT02307955

Last Updated: 2016-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Grade I/II Ankle Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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firefly

participants treated with firefly device

Group Type EXPERIMENTAL

firefly

Intervention Type DEVICE

Control

Standard of care

Group Type OTHER

Standard of care

Intervention Type OTHER

Interventions

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firefly

Intervention Type DEVICE

Standard of care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Firstkind Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Poole NHS Trust Hospital

Poole, Dorset, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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FKD-ffANK-001

Identifier Type: -

Identifier Source: org_study_id

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