Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI)

Craig Hospital

Status: Invitation-only

Conditions: Cervical Spinal Cord Injury

Treatments: Behavioral: FTP Alone; Behavioral: FTP+Con-FES; Behavioral: FTP+WPHF-FES

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05191121

1847023-1

Details and patient eligibility

About

Ninety-nine individuals meeting the study's inclusion/exclusion criteria will be enrolled in this study. The objective of this study is to evaluate three different therapeutic approaches to synergistically retrain functional movement patterns of the upper extremities in combination with trunk stabilization to promote neurologic and functional recovery after SCI. Each subject will complete 40 sessions of intervention. Subjects will also complete a Baseline Evaluation (week 0), Re-Evaluation (week 4), Post Treatment Evaluation (week 8), and a Follow-Up Evaluation (week 12).

Enrollment: 99 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of traumatic SCI
• Less than 5months post SCI
• SCI injury level C1-C8
• SCI categorized as AIS B-D
• Currently receiving inpatient rehabilitation at Craig Hospital
• Passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows
• Demonstrate motor response to electrical stimulation in majority of UE muscle groups below level of injury (tested during screening)
• No complicating physical or cognitive conditions (as determined by their physician) that would preclude safe use of electrical stimulation
• Able to complete study as an outpatient if discharged from inpatient rehabilitation before completing 40 sessions of training

Exclusion criteria

• Unstable chronic cardiac or respiratory complaints
• Current or history of UE contracture or skin pressure injuries that might interfere with intervention
• Received Botox injections within the last 3 months
• Pregnant
• Implanted devices including: pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intra-thecal pump.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 3 patient groups

FTP Alone

Active Comparator group

Description:

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).

Treatment:

Behavioral: FTP Alone

FTP+Con-FES

Active Comparator group

Description:

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.

Treatment:

Behavioral: FTP+Con-FES

FTP+WPHF-FES

Active Comparator group

Description:

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.

Treatment:

Behavioral: FTP+WPHF-FES