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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04523636
Other study ID # HP-00075158
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2018
Est. completion date December 20, 2018

Study information

Verified date August 2020
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 20, 2018
Est. primary completion date December 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Spinal Cord Injury

- Inpatient Rehabilitation

- Limited hand function

Exclusion Criteria:

- Under 18

- Full hand function

- Orthopedic injury to hand

Study Design


Intervention

Device:
Splinting
Pre-fabricated or custom resting hand splints

Locations

Country Name City State
United States University of MD Rehabilitation & Orthopaedic Institute Baltimore Maryland
United States Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Thomas Jefferson University The Craig H. Neilsen Foundation, University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. This assessment was completed within 3 days of discharge and no more than 12 weeks after the intervention was initiated.
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