Evaluation of Splinting in Tetraplegia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Splinting in Tetraplegia

Conditions
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Spinal Cord Injury Cervical, Splints

Intervention / Treatment
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* Device: Splinting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spinal Cord Injury Inpatient Rehabilitation Limited hand function Exclusion Criteria: Under 18 Full hand function Orthopedic injury to hand

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each extremity was randomized to receive a custom or pre-fabricated resting hand splint.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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. |