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Evaluation of Splinting in Tetraplegia

Evaluation of Splinting in Tetraplegia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04523636
Enrollment
36
Registered
2020-08-21
Start date
2018-01-04
Completion date
2018-12-20
Last updated
2020-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury Cervical, Splints

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.

Interventions

DEVICESplinting

Pre-fabricated or custom resting hand splints

Sponsors

University of Maryland, Baltimore
CollaboratorOTHER
The Craig H. Neilsen Foundation
CollaboratorOTHER
Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Each extremity was randomized to receive a custom or pre-fabricated resting hand splint.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Spinal Cord Injury * Inpatient Rehabilitation * Limited hand function

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Splint Perception SurveyThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026