None listed
Conditions
Brief summary
The goal of this project to is explore the immediate response of sitting balance and trunk stability to electrical stimulation used to activate the abdominal muscles in people with chronic SCI. This type of electrical stimulation, called functional electrical stimulation, is used on the abdomen or other areas of the body to help people with SCI and other neurological conditions to perform tasks, cough, work out, or strengthen muscles. We plan to study whether functional electrical stimulation activating or turning on the abdominal muscles can alter the sitting balance response compared to having no functional electrical stimulation. We are targeting the abdominal muscles because they are part of the core musculature and play an important role in balance control. Improving balance and trunk stability is a high priority for people with SCI. Balance and trunk stability are crucial to independence in functional activities or activities that people perform every day like dressing, grooming, eating, toileting, and completing transfers. If there is a positive response to abdominal functional electrical stimulation during balance activities, it could be implemented into daily routines of people with SCI because it is a safe and relatively low-cost intervention.
Interventions
Qualifying participants will be asked to attend two study sessions on two separate days at least 3 but no more than 10 business days apart. Participants will be asked to not alter their routines relating to exercise and will be asked to not directly practice the items related to the FIST-SCI in the interim period between assessments. Every effort will be made to schedule participants at similar times during the day to minimize variability in participant balance response from factors external to
Qualifying participants will be asked to attend two study sessions on two separate days at least 3 but no more than 10 business days apart. Participants will be asked to not alter their routines relating to exercise and will be asked to not directly practice the items related to the FIST-SCI in the interim period between assessments. Every effort will be made to schedule participants at similar times during the day to minimize variability in participant balance response from factors external to the study. Individuals who qualify for this study and provide consent will perform the Function in Sitting Test for people with SCI (FIST-SCI) in two conditions: 1) with abdominal FES and 2) with abdominal functional electrical stimulation (FES) pads applied but not turned on. Only one condition will be completed per study session. The order of condition will be randomly determined by picking out of a hat. The assessor will be blinded to the condition. A separate member of the study team will apply the electrodes and will either turn the stimulation device on (active condition) or keep the device off (sham condition) based on the randomization chosen. The stimulation device will then be put in a bag that will keep the assessor blinded to the stimulator. The unblinded study team member will record the stimulation settings of the active condition and the condition order on a case report form (CRF) that will not be accessed by the blind assessor. For the active abdominal FES condition, electrical current will be adjusted until a strong, visible, and tolerable muscle contraction is observed (typically 50 to 100 mA) like previous studies completed by researchers at NeuRA. Stimulation will be delivered by the Empi (Continuum, Empi, 199610-001). The Empi is a clinically available stimulation device and is currently being used in an approved study (ACTRN12621000386831). The Empi device delivers electric stimulation through electrode pads place postereolaterally on the trunk. When turned on the device will cause a contraction of the underlying muscles. The device will remain on throughout one of the two full balance assessments. We anticipate the first session will take 45-60 minutes at most. We anticipate the second session will take 20-40 minutes at most.
Sponsors
Neuroscience Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age 2. Non-acute SCI, community dwelling person with SCI for at least 6 months 3. Motor Level at the level of T5 or above
Exclusion criteria
1. Non-wheelchair user or regular ambulator 2. No response to abdominal functional electrical stimulation (AFES) or unable to tolerate at intensity needed to evoke a contraction 3. Physical obstacles that prevent use/placement of AFES 4. Implanted pacemaker/ defibrillator or other implanted devices that prevent placement of electrodes 5. Unable t0 assume a sitting position due to current wound or orthostatic intolerance 6. Unable to follow three step commands or cannot comprehend the required balance tasks 7. Women who are pregnant
Outcome results
None listed