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

NCT ID: NCT05191121

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2027-06-30

Brief Summary

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).

Conditions

Cervical Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FTP Alone

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).

Group Type: ACTIVE_COMPARATOR

FTP Alone

Intervention Type: BEHAVIORAL

Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins).

FTP+Con-FES

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 Type: ACTIVE_COMPARATOR

FTP+Con-FES

Intervention Type: BEHAVIORAL

Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). Muscle groups will be stimulated at the same time they would be activated naturally in a pre-injury movement pattern utilizing conventional parameter FES.

FTP+WPHF-FES

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 Type: ACTIVE_COMPARATOR

FTP+WPHF-FES

Intervention Type: BEHAVIORAL

Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). Muscle groups will be stimulated at the same time they would be activated naturally in a pre-injury movement pattern utilizing wide pulse, high frequency parameter FES.

Interventions

FTP Alone

Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins).

Intervention Type: BEHAVIORAL

FTP+Con-FES

Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). Muscle groups will be stimulated at the same time they would be activated naturally in a pre-injury movement pattern utilizing conventional parameter FES.

Intervention Type: BEHAVIORAL

FTP+WPHF-FES

Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). Muscle groups will be stimulated at the same time they would be activated naturally in a pre-injury movement pattern utilizing wide pulse, high frequency parameter FES.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

Craig Hospital

OTHER

Sponsor Role: lead

Responsible Party

Candace Tefertiller

Executive Director Research and Evaluation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Craig Hospital

Englewood, Colorado, United States

Countries

United States

Other Identifiers

1847023-1

Identifier Type: -

Identifier Source: org_study_id