Splint Users' Satisfaction and Functional Status With Custom Finger Splints

Sponsor

NorthShore University HealthSystem (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05903391

Collaborator

(none)

Enrollment

Location

Arms

30.9

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This feasibility and non-randomized comparison study explores the possible benefits of splint design and production by 3D-printing in a clinical setting and looks at splint users' experiences with customizable 3D-printed finger splints compared to conventionally made splints. Fifty participants with a hyperextended finger condition are assigned by researcher to either an interventional group (customizable 3D-printed finger splint) or a control group (conventional thermoplastic finger splint). Participants will wear assigned splint for 1 month. Functional status and satisfaction with splint will be assessed at the end of the 1-month duration in the form of surveys on satisfaction and functional status participants will be asked to complete. The findings will contribute to evidence that customizable 3D-printed finger splints can serve as a feasible, cost-effective option to improve patient satisfaction and functional status. It will further justify the need for the application of 3D-printing in a clinical setting.

Condition or Disease	Intervention/Treatment	Phase
Hypermobility of Interphalangeal Joints Swan-Neck Deformity	Device: Finger Splints	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Screening

Official Title:

Splint Users' Satisfaction and Functional Status With Custom Finger Splints: A Feasibility and Comparison Study

Anticipated Study Start Date :

Jun 5, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3D-Printed Finger Splints Participants who wear the experimental customizable 3D-printed finger splints	Device: Finger Splints The invervention is wearing a finger splint produced by assigned finger splint typically used in a clinical setting
Active Comparator: Conventional Finger Splints Participants who wear the control, conventionally made finger splints	Device: Finger Splints The invervention is wearing a finger splint produced by assigned finger splint typically used in a clinical setting

Arm

Intervention/Treatment

Experimental: 3D-Printed Finger Splints

Participants who wear the experimental customizable 3D-printed finger splints

Device: Finger Splints

The invervention is wearing a finger splint produced by assigned finger splint typically used in a clinical setting

Active Comparator: Conventional Finger Splints

Participants who wear the control, conventionally made finger splints

Device: Finger Splints

The invervention is wearing a finger splint produced by assigned finger splint typically used in a clinical setting

Outcome Measures

Primary Outcome Measures

Orthotics and Prosthetics User Survey - Satisfaction with Device [1 month]
Self-report questionnaire which measures participants satisfaction with assigned splint device
Orthotics and Prosthetics User Survey - Functional Status [1 month]
Self-report questionnaire which measures participants' functional status during the duration of time wearing assigned finger splint device

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Fluent in English
18 years or older
Finger proximal interphalangeal joint (PIP) joint hyperextension (with or without swan-neck deformity)
Pregnant or not pregnant women
Able to tolerate a finger orthosis over the course of 1 month
Not decisionally impaired
Have or have not previously worn a finger orthosis for symptoms

Exclusion Criteria:

Non-fluent in English
Decisionally impaired
Younger than 18 years old
No proximal interphalangeal joint (PIP) joint finger hyperextension
Unable to tolerate a finger orthosis over the course of 1 month

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NorthShore University HealthSystems	Chicago	Illinois	United States	60625

Sponsors and Collaborators

NorthShore University HealthSystem

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Natasha Irani, OTD, OTR/L: Occupational Therapist, NorthShore University HealthSystem

ClinicalTrials.gov Identifier:

NCT05903391

Other Study ID Numbers:

EH23-047

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Natasha Irani, OTD, OTR/L: Occupational Therapist, NorthShore University HealthSystem

Additional relevant MeSH terms:

Congenital Abnormalities

Study Results

No Results Posted as of Jun 18, 2023