About this trial
Overall aim: To identify the impact and acceptability of a novel method of neuromuscular electrical stimulation (NMES) for improving glucose control using a dual stable isotope tracer OGTT in individuals with spinal cord injury (SCI).
Objective 1:
1. To establish the extent to which an acute bout of NMES improves health-related measures of glucose control, compared to a SHAM control trial. 2. To identify the relative magnitude of effect, compared to non-injured control participants (CON).
Hypotheses:
1. NMES will be more effective at improving glucose control by increasing peripheral glucose uptake, relative to SHAM condition. 2. The effect will be greater in individuals with SCI compared to non-injured control participants.
Objective 2:
To investigate the real-world feasibility of NMES as a therapeutic intervention, participants with SCI will be given instructions for 2-weeks of at-home use. In-depth interviews will be conducted to evaluate acceptability and identify areas that could be adapted to effectively implement NMES in a future trial.
Participants will complete two experimental trials in a randomised crossover fashion separated by 7 days which will consist of either a sham control (SHAM) or an acute bout of NMES during a 3-h oral glucose tolerance test (OGTT). Following the experimental trial days, participants with SCI will take home a NMES device and will be given instructions for 2-weeks of at-home NMES use (Figure 1) to assess acceptability and feasibility.
Eligibility criteria
Qualifiers
>1-year postinjury.
18 years of age or above
American Spinal Cord Injury Impairment Scale A-C.
Level of Injury, Cervical 5-Lumbar 2.
Disqualifiers
Has been diagnosed with type 2 diabetes, or actively taking a pharmaceutical to address elevated blood glucose.
Unable to understand explanations and/or provide informed consent.
If you cannot tolerate the NMES intervention
Is pregnant or planning to become pregnant during the study duration
Trial design
Treatments tested in this trial
- NMES
- Sham (No Treatment)
Treatment groups
Sponsors and collaborators
University of Bath
Lead sponsor
University of Birmingham
Collaborator