Evaluation of Splinting in Tetraplegia
Study Details
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 |
|---|---|---|
|
N/A |
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
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
- 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
- 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.
Eligibility Criteria
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of MD Rehabilitation & Orthopaedic Institute | Baltimore | Maryland | United States | 21207 |
| 2 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HP-00075158