What side effects are associated with this type of intervention?

Common treatments for spinal cord injury (SCI) that focus on functional movement retraining and physical rehabilitation, such as physical therapy and occupational therapy, generally have minimal side effects. However, patients may experience muscle soreness, fatigue, and temporary increases in pain as they adjust to new exercises and increased physical activity. In rare cases, overexertion or improper technique can lead to muscle strains or joint injuries. It is important for these therapies to be supervised by experienced professionals to minimize risks and ensure safe and effective treatment.

What prior FDA approvals exist?

There are no specific FDA-approved pharmacological treatments explicitly for enhancing neuroplasticity in spinal cord injury (SCI) similar to the approaches being studied in the trial for functional movement retraining. However, physical rehabilitation techniques such as task-specific and repetitive exercise, constraint-induced motor therapy, and body-weight-supported ambulation are commonly used to promote recovery. These methods focus on synaptogenesis and motor function improvement, which are central to SCI rehabilitation. While pharmacological interventions are being explored, their approval and efficacy remain under investigation.

What other types of research exist?

Promising novel alternatives for functional movement retraining in SCI patients include robotic-assisted gait training, non-invasive brain stimulation (such as transcranial magnetic stimulation), and advanced neuroprosthetics. These therapies aim to enhance neuroplasticity and improve functional outcomes.

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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

Must not have

Received Botox injections within the last 3 months

Current or history of UE contracture or skin pressure injuries that might interfere with intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, week 8, and week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing three different types of physical therapy exercises to help people with spinal cord injuries regain movement in their arms and stabilize their trunk. The goal is to retrain the body to move correctly, improving overall function and stability. Participants will undergo multiple sessions and be evaluated at different stages to track their progress.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received Botox injections in the past 3 months.

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I do not have current or past upper extremity contractures or skin injuries that could affect treatment.

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I have stable heart or lung conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, week 8, and week 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Capabilities of Upper Extremity Test (CUE-T)

Secondary study objectives

Demographic Information

Global Rating of Change (GRC)

Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: 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 II: 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 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).

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for spinal cord injury (SCI) include physical therapy, occupational therapy, and therapeutic exercise. These treatments aim to retrain functional movement patterns and enhance neurologic and functional recovery. Physical therapy focuses on improving mobility, strength, and coordination through graded exercises, which help in reactivating neural pathways and reducing deconditioning. Occupational therapy assists patients in regaining the ability to perform daily activities, thereby improving their independence and quality of life. Therapeutic exercise, including activities like Pilates and aquatic therapy, promotes flexibility, stability, and core strength, which are crucial for overall functional improvement. These treatments are essential for SCI patients as they address both physical and psychological aspects of recovery, leading to better outcomes and enhanced quality of life.

Using non-invasive brain stimulation to augment motor training-induced plasticity.