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The purpose of this feasibility pilot study is to determine the effectiveness of Relative Motion Orthosis (RMO) in regaining finger range of motion compared to standard care in patients diagnosed with Proximal Interphalangeal (PIP) stiffness with an extension lag secondary to finger injury. Participants will be enrolled and randomized into groups receiving either standard conservative interventions or standard interventions in addition to the RMO. The primary endpoint is to evaluate the efficacy of relative motion orthosis in PIP ROM using clinical scoring and physical exam findings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthosis + standard hand therapy care | Experimental | Patients will receive a custom splint/orthosis will be made by the hand therapist for patients to wear through the day for the length of the treatment as much as possible in additional to standard of care hand therapy. Patients will be encouraged use the orthosis during the day (at least 6-8 hours) for 6 weeks. |
|
| Standard of care | Active Comparator | Standard of care (control group) will only complete the routine treatment. This consists of physical therapy exercises, stretches, manual therapy and use of therapeutic modalities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RMO flexion orthosis (splint) | Device | RMO flexion is an orthosis fabricated by hand therapists made of thermoplastic material design to position the involved finger in relative flexion at the metacarpal joint compared to adjacent fingers to facilitate PIP extension during daily activity use. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score | The QuickDASH Questionnaire consists of 30 items where each question in the scale is scored between 1 and 5. The total score ranges from from 0 (no difficulty or symptoms) to 100 (no activity or very severe symptoms). A decrease from baseline indicates improvement in symptoms. | Baseline, End-of-treatment (~Month 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Active Range of Motion (AROM) | Active Range of Motion (AROM) measurement will be evaluated using a universal goniometer. The goniometer is placed at the joint, and the joint is moved through its range of motion. The goniometer measures the angle in degrees, ranging from 0 to 180. An increase from baseline indicates improved range of motion. | Baseline, End-of-treatment (~Month 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalia Ruiz, DPT | Contact | 646-501-4782 | Natalia.ruiz@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Natalia Ruiz, DPT | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset will be shared to achieve aims in the approved proposal beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Natalia.Ruiz@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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| ID | Term |
|---|---|
| D013165 | Splints |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
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|
| Standard of care | Other | Treatment includes finger stretches, active range of motion (AROM), passive range of motion (PROM), thermal modalities, LMB finger extension orthosis. |
|
| D004864 |
| Equipment and Supplies |
| D053831 | Surgical Fixation Devices |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |