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Enrolling by Invitation

NCT Number: NCT05191121

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

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).

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Key information

Conditions

Cervical Spinal Cord Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Craig Hospital

Englewood, Colorado, 80113, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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+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+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.

Primary outcomes

  1. Capabilities of Upper Extremity Test (CUE-T)

    Time frame: Week 0 to Week 12

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

Secondary outcomes

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

    Time frame: Week 0, Week 8, and Week 12

    This multimodal test measures sensorimotor and prehension function in three domains important in describing arm and hand function

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

    Time frame: Week 0, Week 8, and Week 12

    The ISNCSCI involves a detailed examination to determine the sensory level for the right and left sides. The sensory level is the most caudal, intact dermatome. Scores range from 0-2. The higher the score the more intact the dermatome is.

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

    Time frame: Week 0, Week 8, and Week 12

    The ISNCSCI involves a detailed examination to determine motor levels for the right and left sides. The motor level is defined as the lowest key muscle function that has a grade of at least a 3, providing key muscle functions represented by segments above that level are judged to be intact. Scores range from 0-5. The higher the score the more intact the muscle is.

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

    Time frame: Week 0, Week 8, and Week 12

    The ISNCSCI involves a detailed examination to determine the neurological level of injury. The neurological level of injury refers to the most caudal segment of the cord with intact sensation and antigravity muscle function strength, provided that there is normal sensory and motor function rostrally respectively. The neurological level of injury is the most cephalad of the sensory and motor levels.

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

    Time frame: Week 0, Week 8, and Week 12

    The ISNCSCI involves a detailed examination to determine whether a spinal cord injury is complete or incomplete. If an injury is considered complete there is an absence of voluntary anal contraction, absent sensory scores of S4-5, and absence of deep anal pressure.

  6. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Impairment Grade

    Time frame: Week 0, Week 8, and Week 12

    The ISNCSCI involves a detailed examination to determine a spinal cord injury's grade according to the American Spinal Injury Association. Score ranges from A-E. ASIA classification A means spinal injury is considered complete with no sensory or motor function preserved in sacral segments. On the opposite end of the scale an ASIA classification E means 'normal'.

  7. Pinch Force

    Time frame: Week 0, Week 8, and Week 12

    Pinch force will be measured by the Commander Echo Console with the JTech Pinch Dynamometer to quantify finger strength.

  8. Grasp Force

    Time frame: Week 0, Week 8, and Week 12

    Grasp force will be measured by the Commander Echo Console with the JTech Hand Dynamometer to quantify grasp strength.

  9. Modified Functional Reach (MFR)

    Time frame: Week 0, Week 8, and Week 12

    The MFR will be used to measure dynamic trunk stability

  10. Global Rating of Change (GRC)

    Time frame: Week 0, Week 8, and Week 12

    The Global Rating of Change scale assesses perceived change from an intervention. 9 point Likert scale. Higher positive score reflects great improvement

  11. NeuroRecovery Scale (NRS)

    Time frame: Week 0 and Week 4

    The full NRS comprises of 16items. For the purpose of this upper extremity interventional study, only six items will be used that represent a variety of functional upper extremity movement patterns required for ADL management. These scores will be used to guide treatment across all 3 groups. Scores range from 1A-4C. Higher scores reflect greater recovery of spinal cord injury.

  12. Demographic Information

    Time frame: Week 0

    Demographic information will include: age, sex, race/ethnic background, pre-injury education, employment status, marital status, and living situation.

  13. Injury Information

    Time frame: Week 0

    Injury information will include: date of injury, cause of injury, baseline AIS classification, and injury level.

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI): A Randomized Controlled Trial of Three Interventions

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2022
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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