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Orthosis

3D Printed Wrist Orthosis for Carpal Tunnel Syndrome

N/A

Recruiting

Research Sponsored by TOPMED

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 14 of intervention

Awards & highlights

Study Summary

This trial will help develop a new 3D printed orthosis to aid with healing and rehab of wrist/hand injuries, like carpal tunnel & droopy hand, for under $150.

Who is the study for?

This trial is for adults aged 18-70 with conditions like Carpal Tunnel Syndrome, De Quervain's Tenosynovitis, Drop hand, Ulnar nerve damage, Rhizarthrosis or Tendinopathy of the thumb. Participants must be able to express comfort and discomfort clearly. It excludes those with neuromuscular issues, spasticity, paralysis or insensitivity in the upper limbs.Check my eligibility

What is being tested?

The study is testing a new type of wrist and thumb orthosis made using 3D printing technology. The goal is to create an affordable ($150), attachment-free brace that supports healing and rehabilitation for various hand and wrist injuries.See study design

What are the potential side effects?

Potential side effects may include discomfort while wearing the orthosis, skin irritation at contact points or reduced mobility due to improper fit. However, specific side effects will depend on individual experiences.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in pain during treatment from baseline at day 14

Secondary outcome measures

Comfort

Difficulty in donning the orthosis

Functional disability evaluation of the upper member

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Wrist then thumb orthosisExperimental Treatment1 Intervention

Group II: Thumb then wrist orthosisExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MedicusUNKNOWN

TOPMEDLead Sponsor

7 Previous Clinical Trials

508 Total Patients Enrolled

Natural Sciences and Engineering Research Council, CanadaOTHER

57 Previous Clinical Trials

3,069 Total Patients Enrolled

Media Library

Wrist and Thumb Orthosis (Orthosis) Clinical Trial Eligibility Overview. Trial Name: NCT05597930 — N/A

Carpal Tunnel Syndrome Research Study Groups: Wrist then thumb orthosis, Thumb then wrist orthosis

Carpal Tunnel Syndrome Clinical Trial 2023: Wrist and Thumb Orthosis Highlights & Side Effects. Trial Name: NCT05597930 — N/A

Wrist and Thumb Orthosis (Orthosis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05597930 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being admitted to participate in this clinical experiment?

"Affirmative. Clinicaltrials.gov's records indicate that this medical experiment, which was initially posted on May 2nd 2022, is currently recruiting volunteers. Approximately 20 research subjects need to be sourced from one centre."

Answered by AI

Who has been selected as a potential participant for this research?

"This research protocol is seeking 20 participants with carpal tunnel syndrome aged between 18 and 70. To qualify, applicants must meet the following criteria: Be of legal age, Demonstrate an aptitude for describing their comfort or discomfort accurately, Have either Carpal Tunnel Syndrome (CTS), de Quervain's Tenosynovitis (DQT), Drop Hand Syndrome (DHS) or Ulnar Nerve Damage; Tendinopathy of the thumb; and/or ulnar gale."

Answered by AI

Do the requirements for this medical study extend beyond 70 years of age?

"This clinical trial is accepting patients who have attained the age of consent and are younger than 70 years old."

Answered by AI

Are there still openings for participants of this trial?

"Affirmative, clinicaltrials.gov indicates that this medical experiment is still actively seeking participants. It was made available on May 2nd 2022 and the most recent updates were published October 25th 2022; 20 people are needed from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

New 3D Printed Wrist Orthosis

2022. "New 3D Printed Wrist Orthosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05597930.

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