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Evaluation of Splinting in Tetraplegia

Primary Purpose

Spinal Cord Injury Cervical, Splints

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Splinting
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury Cervical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Spinal Cord Injury
  • Inpatient Rehabilitation
  • Limited hand function

Exclusion Criteria:

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

Sites / Locations

  • University of MD Rehabilitation & Orthopaedic Institute
  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Custom Splint

Prefabricated Splint

Arm Description

Custom Splint- Thermoplastic device fabricated by occupational therapist

Prefabricated Splint- Commercially available from Restorative Care of America, Inc (RCAI)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 18, 2020
Last Updated
August 20, 2020
Sponsor
Thomas Jefferson University
Collaborators
University of Maryland, Baltimore, The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04523636
Brief Title
Evaluation of Splinting in Tetraplegia
Official Title
Evaluation of Splinting in Tetraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
University of Maryland, Baltimore, The Craig H. Neilsen Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury Cervical, Splints

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each extremity was randomized to receive a custom or pre-fabricated resting hand splint.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Custom Splint
Arm Type
Active Comparator
Arm Description
Custom Splint- Thermoplastic device fabricated by occupational therapist
Arm Title
Prefabricated Splint
Arm Type
Active Comparator
Arm Description
Prefabricated Splint- Commercially available from Restorative Care of America, Inc (RCAI)
Intervention Type
Device
Intervention Name(s)
Splinting
Intervention Description
Pre-fabricated or custom resting hand splints
Primary Outcome Measure Information:
Title
Change in scores on The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).
Description
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
Time Frame
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 Measure Information:
Title
Splint Perception Survey
Description
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.
Time Frame
This assessment was completed within 3 days of discharge and no more than 12 weeks after the intervention was initiated.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Spinal Cord Injury Inpatient Rehabilitation Limited hand function Exclusion Criteria: Under 18 Full hand function Orthopedic injury to hand
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Gorman, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paula Geigle, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sara Frye, MS
Organizational Affiliation
Thomas Jefferson University
Official's Role
Study Director
Facility Information:
Facility Name
University of MD Rehabilitation & Orthopaedic Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21207
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Splinting in Tetraplegia

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