The effect of an 8-week treatment programme using foot electrical muscle stimulator (EMS) on physical function and leg symptoms in community-dwelling older adults

Not Applicable

Completed

• Conditions: Symptoms of leg discomfort; Musculoskeletal Diseases

• Registration Number: ISRCTN10576209
• Lead Sponsor: Actegy Health Limited.

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36242050/ (added 17/10/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39143586/ (added 15/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-17
• Study Completion: 2022-10-31
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 129

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-perception of performance in everyday living measured using the Canadian Occupational Performance Measure (COPM) at baseline, 8-weeks, 12-weeks.