RightFit
RecruitingNot applicable

Understanding and Enhancing Human Health and Movement

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how electrical stimulation may improve movement and how the body works. It also checks the safety and effectiveness of a device placed inside the body for people with paralysis from a spinal cord injury, stroke, multiple sclerosis (MS), or traumatic brain injury (TBI).

By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18, have fully grown bones, and be able to sign a form agreeing to join.
  • Have paralysis affecting the body’s middle area or legs from a spinal cord injury at C4 or below, stroke, TBI, or MS, without needing a breathing machine.
  • Have muscles in the legs and body’s middle area with working nerves that can respond to stimulation.
  • Have enough support from others and a stable life situation.
  • Be willing to take part in follow-up visits and tests.
  • Have had the injury more than 6 months ago.
  • Have a height and weight the study doctor finds acceptable.
  • Have a nerve condition that a doctor says is stable.

Who can't join

  • Do not speak English, or are pregnant.
  • Have current pressure sores.
  • Have joints stuck in a bent or fixed position, uncontrolled muscle tightness, or limited movement that would interfere with study activities.
  • Have had bones break without a clear cause, very low bone strength, balance-system problems, balance trouble, or falls without a clear cause.
  • Have a new or untreated bone or joint problem, such as a break or dislocation, that prevents standing with weight on the legs or exercising.
  • Have untreated or uncontrolled health problems that make stimulation unsafe, including heart, immune system, lung, kidney, or blood flow problems, diabetes, or high blood pressure.
  • Have a demand pacemaker, which helps the heart beat when needed, or an implanted device that shocks the heart.
  • Have another medical or mental health condition, or a body size or shape, that makes study activities unsafe or unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Skeletal maturity and ability to sign informed consent (\>18 years) * Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs * Innervated and excitable lower extremity and trunk musculature * Adequate social support and stability * Willingness to comply with follow-up procedures * Time post injury greater than six months * Appropriate body habitus (height and weight within acceptable limits as determined by study physician) * Neurologically stable as determined by a physician Exclusion Criteria: * Non-English speaking * Females who are pregnant * Current pressure injuries that would be exacerbated by study activities * Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities * History of spontaneous fractures or other evidence of excessively low bone density * History of vestibular dysfunction, balance problems, or spontaneous falls * Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture. * Acute and/or chronic problems left untreated or not controlled that would put a participant at risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise, diabetes or hypertension * Presence of a demand pacemaker or cardiac defibrillator * Any other medical or psychological condition that would be a contraindication * Current pressure ulcers * Significant range of motion limitations that would compromise study activities * Body habitus that would compromise study activities

Study sites (1)

OH