Evaluation of Splinting in Tetraplegia

This study compared pre-fabricated and custom resting hand splints among people who were in inpatient rehabilitation after a cervical spinal cord injury.

Study Overview

• Status: Completed
• Conditions: Splints; Spinal Cord Injury Cervical
• Intervention / Treatment: Device: Splinting

Detailed Description

This was randomized parallel group controlled clinical trial where arms, not patients were the unit of randomization. This trial was funded by the Craig H. Neilsen Allied Health Professional Development Award of the American Spinal Injury Association (ASIA). This research was conducted at a 32-bed spinal cord injury and multi-trauma rehabilitation unit in an urban center. Participants were recruited from an inpatient spinal cord injury rehabilitation unit. Eligible participants were 18 years or older and undergoing acute rehabilitation after a cervical spinal cord injury with hand function impairment, and the primary occupational therapist deemed splinting intervention was required. Each eligible extremity was randomized to receive a custom or pre-fabricated resting hand splint for night use.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21207
      • University of MD Rehabilitation & Orthopaedic Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Spinal Cord Injury
• Inpatient Rehabilitation
• Limited hand function

Exclusion Criteria:

• Under 18
• Full hand function
• Orthopedic injury to hand

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Custom Splint; Custom Splint- Thermoplastic device fabricated by occupational therapist	Device: Splinting; Pre-fabricated or custom resting hand splints
ACTIVE_COMPARATOR: Prefabricated Splint; Prefabricated Splint- Commercially available from Restorative Care of America, Inc (RCAI)	Device: Splinting; Pre-fabricated or custom resting hand splints

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scores on The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).	This test is a hand function assessment for spinal cord injury consisting of four domains- upper extremity strength, sensation, qualitative prehension, and quantitative prehension. Total scores for each upper extremity are calculated 0-116. Assessment of the Hand in Tetraplegia Using the Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP): Impairment versus Function. Kalsi-Ryan S, Curt A, Fehlings, MG and Verrier MC. Top Spinal Cord Inj Rehabil (2009); 14(4):34-46. - C	This assessment is completed within 5 days of initating the splinting intervention and within 3 days of discharge. Length of time between data collection was limited to 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Splint Perception Survey	This survey gathered participant perceptions via a 5 point Likert scale on the participant's perceptions of the splint's comfort and impact on function and hand position. Additionally, participants were asked to provide their perceptions on challenges to using the splint and advice to future therapists and patients considering splinting.	This assessment was completed within 3 days of discharge and no more than 12 weeks after the intervention was initiated.

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: University of Maryland, Baltimore; The Craig H. Neilsen Foundation
• Investigators: Principal Investigator: Peter Gorman, MD, University of Maryland, Baltimore; Principal Investigator: Paula Geigle, PhD, University of Maryland, Baltimore; Study Director: Sara Frye, MS, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2018
• Primary Completion (ACTUAL): December 20, 2018
• Study Completion (ACTUAL): December 20, 2018

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (ACTUAL): August 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: HP-00075158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No