Evaluation of Splinting in Tetraplegia

NCT ID: NCT04523636

Last Updated: 2020-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-04

Study Completion Date

2018-12-20

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.

Conditions

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Spinal Cord Injury Cervical Splints

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Custom Splint

Custom Splint- Thermoplastic device fabricated by occupational therapist

Group Type ACTIVE_COMPARATOR

Splinting

Intervention Type DEVICE

Pre-fabricated or custom resting hand splints

Prefabricated Splint

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

Group Type ACTIVE_COMPARATOR

Splinting

Intervention Type DEVICE

Pre-fabricated or custom resting hand splints

Interventions

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Splinting

Pre-fabricated or custom resting hand splints

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role collaborator

The Craig H. Neilsen Foundation

OTHER

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Gorman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Paula Geigle, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Sara Frye, MS

Role: STUDY_DIRECTOR

Thomas Jefferson University

Locations

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University of MD Rehabilitation & Orthopaedic Institute

Baltimore, Maryland, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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HP-00075158

Identifier Type: -

Identifier Source: org_study_id

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