Evaluation of Splinting in Tetraplegia

Spinal Cord Injury Cervical Clinical Trial

Official title:

Evaluation of Splinting in Tetraplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523636
• Other study ID #: HP-00075158
• Status: Completed
• Phase: N/A
• Start date: January 4, 2018
• Est. completion date: December 20, 2018

Study information

• Verified date: August 2020
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Spinal Cord Injury

• Inpatient Rehabilitation

• Limited hand function

Exclusion Criteria:

• Under 18

• Full hand function

• Orthopedic injury to hand

Related Conditions & MeSH terms

• Quadriplegia
• Spinal Cord Injuries
• Spinal Cord Injury Cervical
• Splints

Intervention

Device:
• Splinting
Pre-fabricated or custom resting hand splints

Locations

Country	Name	City	State
United States	University of MD Rehabilitation & Orthopaedic Institute	Baltimore	Maryland
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Thomas Jefferson University	The Craig H. Neilsen Foundation, University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.