Evaluation of Splinting in Tetraplegia

Not Applicable

Completed

• Conditions: Spinal Cord Injury Cervical; Splints
• Interventions: Device: Splinting

• Registration Number: NCT04523636
• Lead Sponsor: Thomas Jefferson University

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.

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 Timeline

• Study Start: 2018-01-04
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20
• Status Verified: 2020-08
• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-20
• Last Update Submitted: 2020-08-20
• Study First Posted: 2020-08-21
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Spinal Cord Injury
• Inpatient Rehabilitation
• Limited hand function

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prefabricated Splint	Splinting	Prefabricated Splint- Commercially available from Restorative Care of America, Inc (RCAI)
Custom Splint	Splinting	Custom Splint- Thermoplastic device fabricated by occupational therapist

Primary Outcome Measures

Name	Time	Method
Change in scores on The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).	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

Name	Time	Method
Splint Perception Survey	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.

Trial Locations

Locations (2)

University of MD Rehabilitation & Orthopaedic Institute; 🇺🇸 Baltimore, Maryland, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States