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Functional Task Practice + Electrical Stimulation for Spinal Cord Injury

N/A
Waitlist Available
Research Sponsored by Craig Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently receiving inpatient rehabilitation at Craig Hospital
Less than 5 months post SCI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 8, and week 12
Awards & highlights

Study Summary

This trial will study three different ways to improve movement and stability in the upper body and trunk for people with spinal cord injuries, in the hopes of promoting neurological and functional recovery.

Who is the study for?
This trial is for individuals with a traumatic spinal cord injury (SCI) who are currently in rehabilitation. They must have some movement response to electrical stimulation in their upper body muscles and no severe physical or cognitive issues that would make the treatment unsafe. It's not for those with unstable heart/lung conditions, skin injuries affecting the arms, pregnancy, recent Botox injections, or certain implanted devices.Check my eligibility
What is being tested?
The study compares three treatments aiming to improve arm function and trunk stability after SCI: Functional Task Practice (FTP) alone; FTP combined with conventional Functional Electrical Stimulation (Con-FES); and FTP paired with Weight-Prompted Hand Function FES (WPHF-FES). Participants will undergo 40 sessions of their assigned intervention.See study design
What are the potential side effects?
Potential side effects may include discomfort from electrical stimulation, muscle fatigue during therapy sessions, skin irritation at the site of electrode placement, and possible exacerbation of existing pain due to increased activity during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently in rehab at Craig Hospital.
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My spinal cord injury occurred less than 5 months ago.
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My spinal cord injury is between levels C1 and C8.
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My muscles respond to electrical stimulation after my injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 8, and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 8, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Capabilities of Upper Extremity Test (CUE-T)
Secondary outcome measures
Demographic Information
Global Rating of Change (GRC)
Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)
+10 more

Trial Design

3Treatment groups
Active Control
Group I: FTP+WPHF-FESActive Control1 Intervention
Functional Task Practice + Wide Pulse, High Frequency Functional Electrical Stimulation - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks supplemented with wide pulse, high frequency (1000µs; 100 Hz) functional electrical stimulation (FES) followed by 10 minutes of functional training/carryover in a relevant environment.
Group II: FTP+Con-FESActive Control1 Intervention
Functional Task Practice + Conventional Functional Electrical Stimulation - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks supplemented with conventional parameter (200µs; 40Hz) functional electrical stimulation (FES). followed by 10 minutes of functional training/carryover in a relevant environment.
Group III: FTP AloneActive Control1 Intervention
Functional Task Practice Alone - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks followed by 10 minutes of functional training/carryover in a relevant environment without functional electrical stimulation (FES).

Find a Location

Who is running the clinical trial?

Craig HospitalLead Sponsor
40 Previous Clinical Trials
8,260 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
71 Previous Clinical Trials
9,030 Total Patients Enrolled

Media Library

FTP Alone Clinical Trial Eligibility Overview. Trial Name: NCT05191121 — N/A
Spinal Cord Injury Research Study Groups: FTP+WPHF-FES, FTP+Con-FES, FTP Alone
Spinal Cord Injury Clinical Trial 2023: FTP Alone Highlights & Side Effects. Trial Name: NCT05191121 — N/A
FTP Alone 2023 Treatment Timeline for Medical Study. Trial Name: NCT05191121 — N/A

Frequently Asked Questions

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

Are any additional individuals being accepted into this research endeavor?

"According to the information on clinicaltrials.gov, enrollment for this trial is currently closed as of March 8th 2022. This study was initially posted on February 23rd and has since been superseded by 903 other active studies that are still welcoming patients."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
What site did they apply to?
Craig Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI)
Candace Tefertiller 2022. "Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05191121.
~55 spots leftby Feb 2027
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