Paraplegia Clinical Trials

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Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Our overall objective is to decrease the prevalence of multiple sedentary-related diseases that are secondary consequences of spinal cord injury (SCI). SCI affects motor, sensory and autonomic systems and can cause very limited exercise capacity which then leads to very high rates of obesity, metabolic syndrome, type II diabetes and cardiovascular disease. This randomized controlled study aims to determine whether and how transcutaneous spinal electrical stimulation (TSES) alters acute (immediate) exercise responses in people living with SCI. Exercise responses will be tested during incremental tests to fatigue, and during steady state tests. Testing will occur over several study visits and results will be compared within each individual as well as between groups (tetraplegia and paraplegia) and to a group of reference controls. A number of outcomes will be monitored, including whole-body metabolic responses using a metabolic cart, muscle responses using EMG sensors and muscle oxygenation using near infrared spectroscopy (NIRS) sensors, time to fatigue, power output, as well as perceptions about fatigue and effort. The findings of this study are expected to provide evidence regarding whether and how TSES might improve acute exercise responses in people living with SCI.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• traumatic or non-traumatic spinal cord injury

• Spinal cord injury of at least one year duration, C5 or lower, AIS A - D

• medically stable and healthy enough to engage in and complete exercise requirements

• willing and able to complete the exercise protocols and testing requirements

• able to understand and follow written and verbal instructions from study staff

• able to communicate with study staff about their exercise capabilities and preferences

Locations
Other Locations
Canada
University of Manitoba
RECRUITING
Winnipeg
Contact Information
Primary
Kristine C Cowley, PhD
kristine.cowley@umanitoba.ca
+1 204-789-3305
Backup
Rodrigo Villar, PhD
rodrigo.villar@umanitoba.ca
+1-204-474-8590
Time Frame
Start Date: 2024-06-10
Estimated Completion Date: 2026-10
Participants
Target number of participants: 40
Treatments
Other: Upper body exercise in participants with tetraplegia
TSES during peak and steady state exercise in those with tetraplegia
Other: Upper body exercise in participants with paraplegia
TSES during peak and steady state exercise in those with paraplegia
Other: Upper body exercise in reference control participants
TSES during peak and steady state exercise in reference controls
Other: Rhythmic lower limb neuromuscular electrical stimulation evoked exercise
Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise?
Related Therapeutic Areas
Sponsors
Leads: University of Manitoba

This content was sourced from clinicaltrials.gov