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Enrolling by invitation NCT05191121

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

No phase Interventional Cervical Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FTP Alone, FTP+Con-FES, FTP+WPHF-FES.
Who it may be relevant to
Registry conditions: Cervical Spinal Cord Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Behavioral 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).
  • 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.
  • 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.

Primary outcome measures

  • Capabilities of Upper Extremity Test (CUE-T) [Time frame: Week 0 to Week 12]
Secondary outcome measures (12)
  • Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) [Time frame: Week 0, Week 8, and Week 12]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Level [Time frame: Week 0, Week 8, and Week 12]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Level [Time frame: Week 0, Week 8, and Week 12]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury [Time frame: Week 0, Week 8, and Week 12]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sacral Sparing [Time frame: Week 0, Week 8, and Week 12]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Impairment Grade [Time frame: Week 0, Week 8, and Week 12]
  • Pinch Force [Time frame: Week 0, Week 8, and Week 12]
  • Grasp Force [Time frame: Week 0, Week 8, and Week 12]
  • Modified Functional Reach (MFR) [Time frame: Week 0, Week 8, and Week 12]
  • Global Rating of Change (GRC) [Time frame: Week 0, Week 8, and Week 12]
  • NeuroRecovery Scale (NRS) [Time frame: Week 0 and Week 4]
  • Demographic Information [Time frame: Week 0]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Craig Hospital — Englewood

Identifiers

NCT: NCT05191121 · 1847023-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗