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Purpose

The purpose of this research study is to evaluate the effectiveness of an exercise training intervention (24-36 sessions) to improve muscle strength and endurance in the lower limbs of individuals with paralysis. Specifically, surface electrical stimulation or previously implanted stimulator will be used to stimulate the muscles during various forms of exercise training with the primary focus on improving overall endurance and maximal power output. For this study, peripheral stimulating electrodes will send electrical signals to the muscles enabling the production of coordinated movements for exercise such as cycling or rowing.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Lower limb paralysis due to SCI or other neurological disorder - Greater than 18 years of age - Innervated and excitable lower extremity muscles

Exclusion Criteria

  • Females that are pregnant - Ventilator dependent - Current pressure injuries that would be exacerbated by exercise - History of spontaneous fractures - Cardiovascular or pulmonary disease that would limit the ability to exercise - Uncontrolled diabetes or hypertension - Large body frame that would prevent participant from comfortably fitting the exercise equipment - Any other medical or psychological condition that would be a contraindication to participating in an exercise program

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Exercise Intervention 		Electrical stimulation exercise for three different exercise modalities. Exercise training will consist of 24-36 sessions 2-3 times per week.
  • Other: Exercise with Electrical Stimulation
    Neuromuscular electrical stimulation for paralyzed muscles to complete exercise (cycle ergometer, hybrid arm leg cycle ergometer, rowing ergometer).
    Other names:
    • Electrical Stimulation
    • Exercise

Recruiting Locations

Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio 44106
Contact:
Maura Malenchek, PTA
216-791-3800
maura.malenchek@va.gov

More Details

Status
Recruiting
Sponsor
Louis Stokes VA Medical Center

Study Contact

Maura Malenchek, PTA
216-791-3800
maura.malenchek@va.gov

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.