Evaluation of Splinting in Tetraplegia

• ClinicalTrials.gov Identifier: NCT04523636
• Recruitment Status: Completed
• First Posted: August 21, 2020
• Last Update Posted: August 21, 2020
• Sponsor: Thomas Jefferson University
• Collaborators: University of Maryland, Baltimore; The Craig H. Neilsen Foundation
• Information provided by (Responsible Party): Thomas Jefferson University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injury Cervical; Splints	Device: Splinting	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Each extremity was randomized to receive a custom or pre-fabricated resting hand splint.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Splinting in Tetraplegia
• Actual Study Start Date: January 4, 2018
• Actual Primary Completion Date: December 20, 2018
• Actual Study Completion Date: December 20, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in scores on The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP). [ Time Frame: 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. ]

   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

Secondary Outcome Measures :

1. Splint Perception Survey [ Time Frame: This assessment was completed within 3 days of discharge and no more than 12 weeks after the intervention was initiated. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Spinal Cord Injury
• Inpatient Rehabilitation
• Limited hand function

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Maryland

University of MD Rehabilitation & Orthopaedic Institute

Baltimore, Maryland, United States, 21207

United States, Pennsylvania

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

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

More Information

• Responsible Party: Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT04523636
• Other Study ID Numbers: HP-00075158
• First Posted: August 21, 2020
• Last Update Posted: August 21, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Spinal Cord Injuries; Quadriplegia; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations