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Spinal Stimulation and Exercise for Spinal Cord Injury

N/A
Recruiting
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is between 21 and 70 years of age
Has spinal cord injury (T12 or higher level) of at least 1-year duration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8-11 months
Awards & highlights

Study Summary

This trialtests if spinal cord stimulation combined with physical therapy can improve motor functions in patients with spinal cord injury.

Who is the study for?
This trial is for adults aged 21-70 with spinal cord injuries at T12 or higher, lasting over a year. Participants should be able to perform simple tasks and have mobility issues but must not have severe medical conditions like heart disease or uncontrolled high blood pressure. They need to commit up to five times weekly for therapy sessions and assessments in English, without significant depression or anxiety.Check my eligibility
What is being tested?
The study tests the effectiveness of non-invasive electrical stimulation on the neck and lower back combined with intensive physical therapy to improve movement in people with incomplete tetraplegia and paraplegia. It involves phases of just physical therapy followed by both therapies together, assessing immediate and long-term improvements.See study design
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information; however, as it's a non-invasive procedure involving electrical stimulation and exercise, some possible side effects might include mild discomfort at the stimulation site, muscle fatigue from exercise, or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 70 years old.
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I have had a spinal cord injury above my waist for over a year.
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I have trouble with daily activities due to leg function issues.
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My health is stable, and I don't have heart or lung disease that would stop me from doing leg exercises.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-11 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-11 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Six-Minute Walk Test
Secondary outcome measures
Berg Balance Test
Electromyography
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
+9 more

Trial Design

2Treatment groups
Active Control
Group I: Transcutaneous spinal stimulation & Physical therapyActive Control2 Interventions
Transcutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions
Group II: Physical therapy onlyActive Control1 Intervention
Physical therapy that targets rehabilitation of walking and standing functions

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,744 Previous Clinical Trials
1,848,304 Total Patients Enrolled

Media Library

Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03509558 — N/A
Spinal Cord Injury Research Study Groups: Transcutaneous spinal stimulation & Physical therapy, Physical therapy only
Spinal Cord Injury Clinical Trial 2023: Physical Therapy Highlights & Side Effects. Trial Name: NCT03509558 — N/A
Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03509558 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been admitted to this clinical experiment?

"That is accurate. According to clinicaltrials.gov, this medical trial was originally posted on February 28th 2018 and has been actively seeking participants since then. 10 individuals are needed at 1 site for the experiment to be successful."

Answered by AI

Are applicants aged 25 and older being considered for this clinical trial?

"The study's requirements state that eligible participants must be between 21 and 70 years old. There are 37 clinical trials for individuals aged 18 or younger, and an additional 307 studies recruiting patients over the age of 65."

Answered by AI

Could I qualify to be a participant in this medical experiment?

"This trial is enrolling a maximum of 10 individuals with spinal cord injuries between 21 and 70 years old."

Answered by AI

Have applications for participation in this experiment been opened yet?

"According to clinicaltrials.gov, this research study is still in the process of recruiting patients; it was first listed on February 28th 2018 and most recently edited on November 14th 2022."

Answered by AI

What is the prime objective of this clinical experiment?

"The primary assessment tool employed in this trial over the 8-11 month timeframe is Neuromuscular Recovery Scale. Secondary measures include Neurogenic Bowel Dysfunction Score, which assesses background parameters and impact of bowel management on quality of life; Electromyography recording to measure muscle and nerve function; and a validated self-report questionnaire for assessing bladder symptoms known as the Neurogenic Bladder Symptom Score."

Answered by AI

Who else is applying?

What site did they apply to?
University of Washington
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I would like to see how it does on me. My injury level is T12 and I am 30 years old.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Transcutaneous Spinal Stimulation and Exercise for Locomotion
Chet Moritz 2018. "Transcutaneous Spinal Stimulation and Exercise for Locomotion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03509558.
All > Spinal Cord Injury
~1 spots leftby Sep 2024
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