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

Part of paid clinical trials in Englewood, Colorado.

Sponsor
Craig Hospital
Study ID
NCT05191121
Status
Enrolling By Invitation

Conditions

  • Cervical Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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+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.

Study Details

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).

Key Dates

Start date
Feb 23, 2022
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
99 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: FTP Alone
    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).
  • Active Comparator: FTP+Con-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.
  • Active Comparator: FTP+WPHF-FES
    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.

Primary Outcome Measure

Capabilities of Upper Extremity Test (CUE-T) [ Time Frame: Week 0 to Week 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Craig HospitalEnglewoodColorado80113-

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Craig Hospital· Englewood, CO

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