Proximal Interphalangeal Joint StiffnessNCT06646029
Pilot Study on The Effectiveness of Relative Motion Orthosis in Finger Motion
A study testing RMO flexion orthosis (splint) in people with Proximal Interphalangeal Joint Stiffness, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Proximal Interphalangeal Joint Stiffness
- What is being tested?
- RMO flexion orthosis (splint)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range 18-80
- Any gender
- Any Proximal Interphalangeal (PIP) injury that causes reduced PIP Active Range of Motion (AROM) in extension
- Right or left hand injury
- Level of Chronicity (4 weeks - 6 months)
- Able to follow instructions
Who cannot join
- PIP with hard end feel (feels they need serial casting) - level of chronicity
- Any digital nerve injury / skin laceration that can prevent the patient from using the orthosis
- Severe arthropathy
- Literacy deficits: patients need to be able to follow verbal and written instructions independently to minimize risks and improve outcomes from care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
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.
- Conditions
- Proximal Interphalangeal Joint Stiffness
- Being tested
- RMO flexion orthosis (splint), Standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard of careOther
Treatment includes finger stretches, active range of motion (AROM), passive range of motion (PROM), thermal modalities, LMB finger extension orthosis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RMO flexion orthosis (splint); Other: Standard of care |
| 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. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, End-of-treatment (~Month 3)
Secondary outcomes (1)
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.
Measured: Baseline, End-of-treatment (~Month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start7 Dec 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Interphalangeal Joint StiffnessStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalia Ruiz, DPT, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646029
- Sponsor's protocol ID
- 23-00609
- Status last verified
- Feb 2026
- First submitted
- 15 Oct 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on The Effectiveness of Relative Motion Orthosis in Finger Motion
- ClinicalTrials.gov ID
- NCT06646029
- Acronym / sponsor ID
- 23-00609
- Conditions
- Proximal Interphalangeal Joint Stiffness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Dec 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthosis + standard hand therapy care | Experimental | Device: RMO flexion orthosis (splint), Other: Standard of carePatients 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 | Other: Standard of careStandard of care (control group) will only complete the routine treatment. This consists of physical therapy exercises, stretches, manual therapy and use of therapeutic modalities. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range 18-80
- Any gender
- Any Proximal Interphalangeal (PIP) injury that causes reduced PIP Active Range of Motion (AROM) in extension
- Right or left hand injury
- Level of Chronicity (4 weeks - 6 months)
Key exclusion criteria (4 listed)
- PIP with hard end feel (feels they need serial casting) - level of chronicity
- Any digital nerve injury / skin laceration that can prevent the patient from using the orthosis
- Severe arthropathy
- Literacy deficits: patients need to be able to follow verbal and written instructions independently to minimize risks and improve outcomes from care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RMO flexion orthosis (splint)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. | Device | Orthosis + standard hand therapy care |
| Standard of careTreatment includes finger stretches, active range of motion (AROM), passive range of motion (PROM), thermal modalities, LMB finger extension orthosis. | Other | Orthosis + standard hand therapy care, Standard of care |
Primary outcome
Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score
Time frame: Baseline, End-of-treatment (~Month 3)
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.
1 secondary outcome
Change in Active Range of Motion (AROM)
Time frame: Baseline, End-of-treatment (~Month 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Proximal Interphalangeal Joint Stiffness
Recruiting
Effectiveness of Exercise Relative Motion Orthoses for Limited Finger Joint Motion
Proximal Interphalangeal Joint Stiffness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalia Ruiz, DPT principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RMO flexion orthosis (splint) in people with Proximal Interphalangeal Joint Stiffness, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Ruiz, DPT (646-501-4782, Natalia.ruiz@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score (time frame: Baseline, End-of-treatment (~Month 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.