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Completed

NCT Number: NCT04523636

Evaluation of Splinting in Tetraplegia

This study compared pre-fabricated and custom resting hand splints among people who were in inpatient rehabilitation after a cervical spinal cord injury.

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Key information

Conditions

Spinal Cord Injury Cervical Splints

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of MD Rehabilitation & Orthopaedic Institute, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spinal Cord Injury
  • Inpatient Rehabilitation
  • Limited hand function

Exclusion criteria

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

Treatment and study plan

Splinting

Device

Pre-fabricated or custom resting hand splints

Primary outcomes

  1. Change in scores on The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).

    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.

    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 outcomes

  1. Splint Perception Survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • The Craig H. Neilsen Foundation
  • University of Maryland, Baltimore

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2020
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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