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

Primary Purpose

Cervical Spinal Cord Injury

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FTP Alone
FTP+Con-FES
FTP+WPHF-FES
Sponsored by
Craig Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Craig Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

FTP Alone

FTP+Con-FES

FTP+WPHF-FES

Arm 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).

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)
This multimodal test measures sensorimotor and prehension function in three domains important in describing arm and hand function
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Level
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.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Level
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.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury
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.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sacral Sparing
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.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Impairment Grade
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'.
Pinch Force
Pinch force will be measured by the Commander Echo Console with the JTech Pinch Dynamometer to quantify finger strength.
Grasp Force
Grasp force will be measured by the Commander Echo Console with the JTech Hand Dynamometer to quantify grasp strength.
Modified Functional Reach (MFR)
The MFR will be used to measure dynamic trunk stability
Global Rating of Change (GRC)
The Global Rating of Change scale assesses perceived change from an intervention. 9 point Likert scale. Higher positive score reflects great improvement
NeuroRecovery Scale (NRS)
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.
Demographic Information
Demographic information will include: age, sex, race/ethnic background, pre-injury education, employment status, marital status, and living situation.
Injury Information
Injury information will include: date of injury, cause of injury, baseline AIS classification, and injury level.

Full Information

First Posted
December 28, 2021
Last Updated
March 8, 2022
Sponsor
Craig Hospital
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT05191121
Brief Title
Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI)
Official Title
Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI): A Randomized Controlled Trial of Three Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Craig Hospital
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FTP Alone
Arm Type
Active Comparator
Arm 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).
Arm Title
FTP+Con-FES
Arm Type
Active Comparator
Arm 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.
Arm Title
FTP+WPHF-FES
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
FTP Alone
Intervention Description
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
Intervention Name(s)
FTP+Con-FES
Intervention Description
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
Intervention Name(s)
FTP+WPHF-FES
Intervention Description
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 Measure Information:
Title
Capabilities of Upper Extremity Test (CUE-T)
Description
32 item test, each item scored on a 0-4 point scale with total scores ranging from 0-128.
Time Frame
Week 0 to Week 12
Secondary Outcome Measure Information:
Title
Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)
Description
This multimodal test measures sensorimotor and prehension function in three domains important in describing arm and hand function
Time Frame
Week 0, Week 8, and Week 12
Title
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Level
Description
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.
Time Frame
Week 0, Week 8, and Week 12
Title
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Level
Description
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.
Time Frame
Week 0, Week 8, and Week 12
Title
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury
Description
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.
Time Frame
Week 0, Week 8, and Week 12
Title
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sacral Sparing
Description
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.
Time Frame
Week 0, Week 8, and Week 12
Title
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Impairment Grade
Description
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'.
Time Frame
Week 0, Week 8, and Week 12
Title
Pinch Force
Description
Pinch force will be measured by the Commander Echo Console with the JTech Pinch Dynamometer to quantify finger strength.
Time Frame
Week 0, Week 8, and Week 12
Title
Grasp Force
Description
Grasp force will be measured by the Commander Echo Console with the JTech Hand Dynamometer to quantify grasp strength.
Time Frame
Week 0, Week 8, and Week 12
Title
Modified Functional Reach (MFR)
Description
The MFR will be used to measure dynamic trunk stability
Time Frame
Week 0, Week 8, and Week 12
Title
Global Rating of Change (GRC)
Description
The Global Rating of Change scale assesses perceived change from an intervention. 9 point Likert scale. Higher positive score reflects great improvement
Time Frame
Week 0, Week 8, and Week 12
Title
NeuroRecovery Scale (NRS)
Description
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.
Time Frame
Week 0 and Week 4
Title
Demographic Information
Description
Demographic information will include: age, sex, race/ethnic background, pre-injury education, employment status, marital status, and living situation.
Time Frame
Week 0
Title
Injury Information
Description
Injury information will include: date of injury, cause of injury, baseline AIS classification, and injury level.
Time Frame
Week 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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