Title {1} | The effect of an 8-week treatment program using a novel foot neuromuscular electrical stimulator on physical function, leg pain, leg symptoms and leg blood flow in community-dwelling older adults: a randomized sham-controlled trial] |
Trial registration {2a and 2b}. | ISRCTN10576209 |
Protocol version {3} | Version 4.0, dated 12 July 2022. |
Funding {4} |
Actegy Limited (Bracknell, UK) provided funding for: development of the trial protocol and analysis plan; carrying out all aspects of the trial including participant recruitment, outcome assessment, delivery of the intervention, monitoring data quality, data analysis and reporting, and publication of findings; fixed costs including printing, equipment and software licensing; participant-related costs including consumables, recruitment-related costs, and participant transport; staff costs for the trial coordinator and research assistants, and consultancy costs for statistical and medical support as required. Statistical analysis is also funded by Actegy. Actegy Limited provides Revitive and sham devices for use in the trial. |
Author details {5a} |
B Kumaran, School of Health and Social Work, University of Hertfordshire, Hatfield, UK. D Targett, Primoris Contract Solutions Ltd, 22 Redwood Drive, Ascot, UK T Watson, School of Health and Social Work, University of Hertfordshire, Hatfield, UK. |
Name and contact information for the trial sponsor {5b} | University of Hertfordshire, Hatfield, UK |
Role of sponsor {5c} | The University of Hertfordshire takes responsibility for the trial protocol, conduct and reporting. |