Neuropathy, Oedema
Conditions
Brief summary
This study aims to facilitate further optimization of a neuromuscular electrical stimulation device for use in patients whom are suffering from oedema and neuropathy
Interventions
DEVICEelectrical stimulation
Sponsors
Firstkind Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years and over 2. Be a non-responder to the geko MK1&2 device 3. Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form. 4. Able and willing to follow the protocol requirements.
Exclusion criteria
1. Has a pacemaker 2. Pregnancy. 3. Is contraindicated for the MK1&2 device and/or the Digitimer DS7A 4. Recently diagnosed or suspected DVT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observable foot twitch in response to stimulation with Digitimer DS7A | up to 2 hours | Upon application of the electrical stimulation, parameters required to achieve an outward deflection of the foot will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | up to 2 hours | Any adverse events recorded during the study will be recorded |
| oedema | up to 2 hours | oedema will be measured to classify the level of swelling in the participants leg |
| patient rated tolerability questionnaire | up to 2 hours | Upon sufficient electrical stimulation to gain an outward deflection of the foot the patient will be asked to complete a tolerability questionnaire |
Countries
United Kingdom
Outcome results
None listed