Clinical trial NCT05191121: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cervical Spinal Cord Injury
Lead sponsor: Craig Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2022-01-13
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Capabilities of Upper Extremity Test (CUE-T)
timeFrame: Week 0 to Week 12
Secondary outcomes:
measure: Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)
timeFrame: Week 0, Week 8, and Week 12
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Level
timeFrame: Week 0, Week 8, and Week 12
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Level
timeFrame: Week 0, Week 8, and Week 12
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury
timeFrame: Week 0, Week 8, and Week 12
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sacral Sparing
timeFrame: Week 0, Week 8, and Week 12
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Impairment Grade
timeFrame: Week 0, Week 8, and Week 12
measure: Pinch Force
timeFrame: Week 0, Week 8, and Week 12
measure: Grasp Force
timeFrame: Week 0, Week 8, and Week 12
measure: Modified Functional Reach (MFR)
timeFrame: Week 0, Week 8, and Week 12
measure: Global Rating of Change (GRC)
timeFrame: Week 0, Week 8, and Week 12
measure: NeuroRecovery Scale (NRS)
timeFrame: Week 0 and Week 4
measure: Demographic Information
timeFrame: Week 0
measure: Injury Information
timeFrame: Week 0
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
References: