Evaluation of Splinting in Tetraplegia

NCT04523636 | Completed

• 1 other identifier: HP-00075158
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injury Cervical; Splints

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Splint Perception Survey

  This assessment was completed within 3 days of discharge and no more than 12 weeks after the intervention was initiated.

Study Arms (2)

Custom Splint

ACTIVE COMPARATOR

Custom Splint- Thermoplastic device fabricated by occupational therapist

Device: Splinting

Prefabricated Splint

ACTIVE COMPARATOR

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

Device: Splinting

Interventions

Splinting DEVICE

Pre-fabricated or custom resting hand splints

Custom Splint; Prefabricated Splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spinal Cord Injury
• Inpatient Rehabilitation
• Limited hand function

You may not qualify if:

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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• University of Maryland, Baltimore: collaborator
• The Craig H. Neilsen Foundation: collaborator

Study Sites (2)

University of MD Rehabilitation & Orthopaedic Institute

Baltimore, Maryland, 21207, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Splints

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Peter Gorman, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Paula Geigle, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Sara Frye, MS

  Thomas Jefferson University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: January 4, 2018
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)