Symptoms of leg discomfort Musculoskeletal Diseases
Conditions
Interventions
Current intervention as of 03/03/2022:
Participants will be randomised to three groups, each receiving a different type of foot electrical muscle stimulation, EMS (Group 1: EMS Type 1 in a low sensory
Group 2: EMS Type 2 in a standard motor mode
Group 3: EMS Type 3 in a high motor mode). The randomisation will be performed with concealed envelopes, which will be prepared a priori using a computer-generated randomisation chart (IBM SPSS Statis
Sponsors
Actegy Health Limited.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 06/04/2021: Community-dwelling adults aged over 65 years affected by one or more of the following symptoms: 1. Heaviness in the leg. 2. Cramps in the leg, mainly during the night or at rest. 3. Aching in the leg. 4. Tiredness in the leg. _____ Previous inclusion criteria: Community-dwelling adults over the age of 65 affected by one or more of the following symptoms: 1. Swelling, mainly in the lower leg, ankle or foot. 2. Heaviness in the leg. 3. Cramps in the leg, mainly during the night or at rest. 4. Aching in the leg. 5. Tiredness in the leg.
Exclusion criteria
Exclusion criteria: 1. Significant co-morbidities such as diabetic neuropathy. 2. Significant injury to the leg(s) in the last 6 months. 3. Active cancer. 4. Electronic implants in the body. 5. People who have recently used/currently using foot EMS. 6. Non-ambulant people. 7. Inability to consent or communicate in English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-perception of performance in everyday living measured using the Canadian Occupational Performance Measure (COPM) at baseline, 8-weeks, 12-weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/03/2022: 1. Symptoms of heaviness, tiredness, aching and cramps in legs and feet in the preceding 2 weeks measured using a 0 - 10 numerical rating scale (NRS) at baseline, 8 weeks and 12 weeks 2. Pain measured using a 0 - 10 numerical pain rating scale (NPRS) at baseline, 8 weeks and 12 weeks 3. Deep leg blood flow measured at the ankle using Doppler ultrasound before and during EMS use Previous secondary outcome measures from 06/04/2021 to 07/03/2022: 1. Symptoms of heaviness, tiredness, aching and cramps in legs and feet in the preceding 2 weeks measured using a 0 - 10 numerical rating scale (NRS) recorded in a symptom diary weekly from the end of week 1 to the end of week 7 2. Pain measured using a 0-10 visual analog scale (VAS) at baseline, 8 weeks and 12 weeks Original secondary outcome measures: 1. Symptoms of heaviness, tiredness, aching and cramps in legs and feet in the preceding two weeks measured using a 0 - 10 NRS recorded in a symptom diary weekly from the end of week 1 to the end of week 7 2. Pain measured using 0 -10 VAS at baseline, 8-weeks, 12-weeks 3. Limb volume (for people with ankle and foot swelling) measured using a Perometer at baseline, 8-weeks, 12-weeks | — |
Countries
England, United Kingdom
Outcome results
None listed