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

NCT05191121 | Enrolling By Invitation

• 1 other identifier: 1847023-1
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Capabilities of Upper Extremity Test (CUE-T)

  32 item test, each item scored on a 0-4 point scale with total scores ranging from 0-128.

  Week 0 to Week 12

Secondary Outcomes (13)

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

  Week 0, Week 8, and Week 12

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Level

  Week 0, Week 8, and Week 12

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Level

  Week 0, Week 8, and Week 12

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury

  Week 0, Week 8, and Week 12

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sacral Sparing

  Week 0, Week 8, and Week 12

Study Arms (3)

FTP Alone

ACTIVE COMPARATOR

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).

Behavioral: FTP Alone

FTP+Con-FES

ACTIVE COMPARATOR

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.

Behavioral: FTP+Con-FES

FTP+WPHF-FES

ACTIVE COMPARATOR

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.

Behavioral: FTP+WPHF-FES

Interventions

FTP Alone 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 Alone

FTP+Con-FES 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+Con-FES

FTP+WPHF-FES 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.

FTP+WPHF-FES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Craig Hospital: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director Research and Evaluation

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 13, 2022
• Study Start: February 23, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)