Proximal Interphalangeal Joint StiffnessExercise RM-ONCT06985459
Effectiveness of Exercise Relative Motion Orthoses for Limited Finger Joint Motion
A study testing PIP extension deficit treated with an exercise RMF orthosis and PIP flexion deficits treated with an exercise RME orthosis in people with Proximal Interphalangeal Joint Stiffness, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This randomized controlled trial investigates the effectiveness of two exercise orthosis designs-the Relative Motion Flexion (RMF) and Relative Motion Extension (RME) orthoses-for improving motion in patients with proximal interphalangeal joint (PIPJ) flexion or extension deficits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Interphalangeal Joint Stiffness
- What is being tested?
- PIP extension deficit treated with an exercise RMF orthosis and PIP flexion deficits treated with an exercise RME orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2025to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PIPJ motion deficit with a minimum difference of 10° between passive and active motion
- To have an acute injury, i.e. operated on or within maximum 6 weeks of accident
- Only one hand is affected
- Adult patients over 18 years of age
- Understanding German, French or English
- Hand therapy treatment in-house at Inselspital in Bern
- Ability to give informed consent as documented by signature
Who cannot join
- Previous injuries to the hand or PIPJ (e.g., intra-articular fractures, PIPJ ligament damage) that may limit baseline joint mobility and influence responsiveness to the intervention.
- Presence of conditions such as osteoarthritis (OA) or rheumatoid arthritis (RA) that may affect PIPJ stiffness, pain, or inflammation.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia
- Boutonniere deformity
- Minors (below 18 years of age)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Bern
Bern, Canton of Bern, 3010
Bernadette Christina Tobler-Ammann, PhD, +41 31 632 85 58, bernadette.tobler@insel.ch
Jennifer Niederhäuser, Bachelor in OT, +41 31 632 85 58, jenny.niederhaeuser@insel.ch
About this study
Official title: Effectiveness of Exercise Relative Motion Orthoses for Improving Limited Proximal Phalangeal Joint Motion: A Single-Center, Single-Blinded Randomized Controlled Trial
This randomized controlled trial investigates the effectiveness of two exercise orthosis designs-the Relative Motion Flexion (RMF) and Relative Motion Extension (RME) orthoses-for improving motion in patients with proximal interphalangeal joint (PIPJ) flexion or extension deficits. A total of 148 adult patients with acute hand injuries and a minimum 10° difference between active and passive PIP joint motion will be enrolled. Participants are stratified by their primary motion deficit and randomized to either the exercise orthosis or placebo orthosis group. The orthosis is worn for 4 weeks, with follow-up assessments at weeks 6 and 8 to evaluate range of motion and patient satisfaction. All participants will continue standard hand therapy throughout the study.
Read the detailed description
The prevention and treatment of proximal interphalangeal joint (PIPJ) contractures are key goals in hand rehabilitation, often addressed with orthotic interventions. The choice of orthosis design depends on the severity and timing of the injury or disease. During the acute stage, static splinting is typically used, while more dynamic orthoses, such as static-progressive splinting, are recommended in the chronic stages to manage contractures. If a contracture already exists, hand therapists differentiate between dynamic and fixed deformities in PIPJ flexion or extension. Fixed deformities do not or hardly respond to passive mobilisation, while dynamic deformities show a difference in active and passive range of PIPJ motion - e.g. in cases of soft tissue adhesions hindering active motion.
In addition to traditional passive orthoses, which stretch the PIPJ in a fixed position during dedicated periods, exercise-based orthoses (relative motion orthoses, RM) have been developed to enhance PIPJ mobility during everyday activities. These include Relative Motion Extension (RME) and Relative Motion Flexion (RMF) orthoses, designed to improve both flexion and extension. Studies have shown that RME orthoses improve active flexion, while RMF orthoses aid in active extension, with patients reporting high satisfaction and functional benefits from using these devices in daily tasks. Furthermore, RM orthoses have been widely adopted by therapists, demonstrating benefits in improving functional hand use and promoting non-intentional exercise.
Since the use of relative motion (RM) orthoses - especially as exercise orthoses - is relatively new, few prospective studies have examined their effectiveness in improving PIPJ motion. Therefore, this study aims to compare the effectiveness of exercise RM orthoses with a placebo orthosis to identify the most beneficial treatment strategies for patients with limited PIPJ motion. The goal is to strengthen the evidence base and refining the clinical application of exercise-based orthotic interventions.
The primary objective of this study is to compare the effectiveness of two orthoses designs, the exercise RME and RMF orthosis vs. a placebo orthosis.
Secondary objectives are:
- To evaluate if there is a clinically relevant difference in activity performance at 4 and 8 weeks after orthosis fabrication.
- To assess if there is a statistically significant difference in patient satisfaction with (i) the orthosis and (ii) treatment outcome (satisfaction with the daily use of the hand) after 4 weeks (i and ii) and 8 weeks (ii).
- To document adherence to orthotic intervention from baseline to 4 weeks. We strive for 37 patients per arm and a total sample size of 74 patients per study group. This results in 74 patients in the extension-group and 74 patients in the flexion-group and a total of 148 patients enrolled in this study.
- Conditions
- Proximal Interphalangeal Joint Stiffness
- Being tested
- PIP extension deficit treated with an exercise RMF orthosis, PIP extension deficit treated with a placebo RMF orthosis, PIP flexion deficits treated with a placebo RMF orthosis, PIP flexion deficits treated with an exercise RME orthosis
- Keywords
- Proximal Interphalangeal Joint, Limited Range of Motion, Exercise Relative Motion Orthosis, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIP extension deficit treated with an exercise RMF orthosisDevice
The RM orthoses will be worn between 6-12 hours per day during functional use.
PIP extension deficit treated with a placebo RMF orthosisDevice
The placebo orthosis has the same design as the exercise RM orthoses, but without a difference in the extension or flexion angle, respectively, to the adjacent finger - therefore neutralizing the "quadriga phenomena", which is the effect that makes RM orthoses work.
PIP flexion deficits treated with a placebo RMF orthosisDevice
The placebo orthosis have the same design as the exercise RM orthoses, but without a difference in the extension or flexion angle, respectively, to the adjacent finger - therefore neutralizing the "quadriga phenomena", which is the effect that makes RM orthoses work.
PIP flexion deficits treated with an exercise RME orthosisDevice
The dedicated orthosis wearing time is 6-12 hours per day during functional use.
| Study group | Role | What they receive |
|---|---|---|
| PIP extension deficit treated with an exercise RMF orthosis | Experimental | The orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed. Receives: Device: PIP extension deficit treated with an exercise RMF orthosis |
| PIP extension deficit treated with a placebo RMF orthosis | Placebo comparator | The orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed. Receives: Device: PIP extension deficit treated with a placebo RMF orthosis |
| PIP flexion deficits treated with an exercise RME orthosis | Active comparator | The orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed. Receives: Device: PIP flexion deficits treated with an exercise RME orthosis |
| PIP flexion deficits treated with a placebo RMF orthosis | Placebo comparator | The orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed Receives: Device: PIP flexion deficits treated with a placebo RMF orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger range of motion
PIPJ active and passive motion will be measured using a hand-held goniometer. The goniometer is placed dorsal to the joint in all cases with the arms of the goniometer aligned on the finger bones. The DIP, the PIP and MCP joints will be measured in both extension and flexion range of motion. The degrees of measurement will be noted using the neutral-zero method.
Measured: Change from baseline to 2, 4 and 6 weeks
Secondary outcomes (3)
Patient satisfaction
The ICHOM Satisfaction with treatment results questionnaire will be used to assess patient satisfaction. "Treatment" will be replaced by "orthosis" to assess orthotic satisfaction for the 2 and 4 week measurement. To assess satisfaction with treatment outcome, the questionnaire will be used in its original form
Measured: Change from baseline to 2, 4 and 8 weeks
Patient Specific Functional Scale (PSFS)
To measure activity performance and satisfaction with the performance, the investigators will use the Patient Specific Functional Scale (PSFS). The PSFS is a patient specific and activity based short questionnaire where patients must name up to five activities that are currently difficult to do because of the motion limitations in the PIPJ, and give a score from 0-10. At follow-up, patients just must rescore the activities. The total of the scores is then summed up and divided by the numbers of given activities, which is the total score. The difference is considered significant if there is a change of minimum two points for individual activities or of three points for the total score. The PSFS is a reliable, valid, and responsive tool for measuring outcomes in patients with upper extremity issues.
Measured: Change from baseline to 4 and 8 weeks
Orthosis diary
To monitor adherence with the orthotic intervention, the investigators will give the participants an orthosis diary, where they will note their total orthosis wearing time, whether they were satisfied with their hand performance while wearing the orthosis and when during the day they have been wearing the orthosis. Additionally, the perceived level of pain at rest and while moving before and after the dedicated orthosis wearing time of 6-12 hours per day will be documented.
Measured: continuous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Proximal Interphalangeal Joint StiffnessStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Model description
- The investigators plan to stratify participants into two groups based on their greater PIPJ movement deficit (in flexion or in extension). Within each group, they are randomized to one of the orthosis interventions. This trial has four intervention arms: * Arm 1: PIP extension deficit treated with an exercise RMF orthosis. * Arm 2: PIP extension deficit treated with a placebo RMF orthosis. * Arm 3: PIP flexion deficits treated with an exercise RME orthosis. * Arm 4: PIP flexion deficits treated with a placebo RMF orthosis.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernadette Tobler, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985459
- Sponsor's protocol ID
- RM Orthosis Study 2025-00427
- Acronym
- Exercise RM-O
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to publish our results in ICMJE journals.
Publications
Glasgow C, Fleming J, Tooth LR, Peters S. Randomized controlled trial of daily total end range time (TERT) for Capener splinting of the stiff proximal interphalangeal joint. Am J Occup Ther. 2012 Mar-Apr;66(2):243-8. doi: 10.5014/ajot.2012.002816.
PubMed 22394534Horn KK, Jennings S, Richardson G, Vliet DV, Hefford C, Abbott JH. The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure. J Orthop Sports Phys Ther. 2012 Jan;42(1):30-42. doi: 10.2519/jospt.2012.3727. Epub 2011 Oct 25.
PubMed 22031594Hefford C, Abbott JH, Arnold R, Baxter GD. The patient-specific functional scale: validity, reliability, and responsiveness in patients with upper extremity musculoskeletal problems. J Orthop Sports Phys Ther. 2012 Feb;42(2):56-65. doi: 10.2519/jospt.2012.3953. Epub 2012 Feb 1.
PubMed 22333510Schreuders TA. The quadriga phenomenon: a review and clinical relevance. J Hand Surg Eur Vol. 2012 Jul;37(6):513-22. doi: 10.1177/1753193411430810. Epub 2011 Dec 14.
PubMed 22170246Shaw AV, Verma Y, Tucker S, Jain A, Furniss D. Relative motion orthoses for early active motion after finger extensor and flexor tendon repairs: A systematic review. J Hand Ther. 2023 Apr-Jun;36(2):332-346. doi: 10.1016/j.jht.2023.02.011. Epub 2023 Apr 8.
PubMed 37037728Arslan OB, Sigirtmac IC, Ayvali C, Bas CE, Ayhan E, Bilgin SS, Oksuz C. The Use of Relative Motion Flexion Orthoses for Chronic Boutonniere Deformity. J Hand Surg Am. 2024 May;49(5):488.e1-488.e8. doi: 10.1016/j.jhsa.2022.08.007. Epub 2022 Oct 4.
PubMed 36202676Yates SE, Glinsky JV, Hirth MJ, Fuller JT. The use of exercise relative motion orthoses to improve proximal interphalangeal joint motion: A survey of Australian hand therapy practice. J Hand Ther. 2023 Apr-Jun;36(2):414-424. doi: 10.1016/j.jht.2022.12.002. Epub 2023 Apr 6.
PubMed 37031058Arslan OB, Sahin Y, Sigirtmac IC, Yildiz B, Ayhan E, Oksuz C. Use of relative motion orthoses from the perspective of hand-injured patients: A qualitative study. J Hand Ther. 2023 Apr-Jun;36(2):425-432. doi: 10.1016/j.jht.2023.02.003. Epub 2023 Apr 8.
PubMed 37037730Howell JW, Ewald SG, Schwartz DA. Exercise relative motion orthoses: Use of the pencil test and variations of its use for assessing and managing different finger conditions. J Hand Ther. 2023 Apr-Jun;36(2):473-478. doi: 10.1016/j.jht.2022.10.004. Epub 2023 Mar 11. No abstract available.
PubMed 36914489Wajon S, Howell JW. Prescription of exercise relative motion orthoses to improve limited proximal interphalangeal joint movement: A prospective, multi-center, consecutive case series. J Hand Ther. 2023 Apr-Jun;36(2):378-388. doi: 10.1016/j.jht.2021.09.006. Epub 2022 Jan 14.
PubMed 35039211Michlovitz SL, Harris BA, Watkins MP. Therapy interventions for improving joint range of motion: A systematic review. J Hand Ther. 2004 Apr-Jun;17(2):118-31. doi: 10.1197/j.jht.2004.02.002.
PubMed 15162100Yates SE, Glinsky JV, Hirth MJ, Fuller JT. Orthotic interventions for restoring proximal interphalangeal joint motion for patients with hand injuries or conditions: A systematic review and meta-analysis. J Hand Ther. 2024 Oct-Dec;37(4):495-506. doi: 10.1016/j.jht.2023.12.018. Epub 2024 Jan 26.
PubMed 38278697Kamnerdnakta S, Huetteman HE, Chung KC. Complications of Proximal Interphalangeal Joint Injuries: Prevention and Treatment. Hand Clin. 2018 May;34(2):267-288. doi: 10.1016/j.hcl.2017.12.014.
PubMed 29625645
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercise Relative Motion Orthoses for Improving Limited Proximal Phalangeal Joint Motion: A Single-Center, Single-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06985459
- Acronym / sponsor ID
- Exercise RM-O / RM Orthosis Study 2025-00427
- Conditions
- Proximal Interphalangeal Joint Stiffness
- Keywords
- Proximal Interphalangeal Joint, Limited Range of Motion, Exercise Relative Motion Orthosis, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 22 May 2025 (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.
This randomized controlled trial investigates the effectiveness of two exercise orthosis designs-the Relative Motion Flexion (RMF) and Relative Motion Extension (RME) orthoses-for improving motion in patients with proximal interphalangeal joint (PIPJ) flexion or extension deficits. A total of 148 adult patients with acute hand injuries and a minimum 10° difference between active and passive PIP joint motion will be enrolled. Participants are stratified by their primary motion deficit and randomized to either the exercise orthosis or placebo orthosis group. The orthosis is worn for 4 weeks, with follow-up assessments at weeks 6 and 8 to evaluate range of motion and patient satisfaction. All participants will continue standard hand therapy throughout the study.
Detailed description
The prevention and treatment of proximal interphalangeal joint (PIPJ) contractures are key goals in hand rehabilitation, often addressed with orthotic interventions. The choice of orthosis design depends on the severity and timing of the injury or disease. During the acute stage, static splinting is typically used, while more dynamic orthoses, such as static-progressive splinting, are recommended in the chronic stages to manage contractures. If a contracture already exists, hand therapists differentiate between dynamic and fixed deformities in PIPJ flexion or extension. Fixed deformities do not or hardly respond to passive mobilisation, while dynamic deformities show a difference in active and passive range of PIPJ motion - e.g. in cases of soft tissue adhesions hindering active motion.
In addition to traditional passive orthoses, which stretch the PIPJ in a fixed position during dedicated periods, exercise-based orthoses (relative motion orthoses, RM) have been developed to enhance PIPJ mobility during everyday activities. These include Relative Motion Extension (RME) and Relative Motion Flexion (RMF) orthoses, designed to improve both flexion and extension. Studies have shown that RME orthoses improve active flexion, while RMF orthoses aid in active extension, with patients reporting high satisfaction and functional benefits from using these devices in daily tasks. Furthermore, RM orthoses have been widely adopted by therapists, demonstrating benefits in improving functional hand use and promoting non-intentional exercise.
Since the use of relative motion (RM) orthoses - especially as exercise orthoses - is relatively new, few prospective studies have examined their effectiveness in improving PIPJ motion. Therefore, this study aims to compare the effectiveness of exercise RM orthoses with a placebo orthosis to identify the most beneficial treatment strategies for patients with limited PIPJ motion. The goal is to strengthen the evidence base and refining the clinical application of exercise-based orthotic interventions.
The primary objective of this study is to compare the effectiveness of two orthoses designs, the exercise RME and RMF orthosis vs. a placebo orthosis.
Secondary objectives are:
- To evaluate if there is a clinically relevant difference in activity performance at 4 and 8 weeks after orthosis fabrication.
- To assess if there is a statistically significant difference in patient satisfaction with (i) the orthosis and (ii) treatment outcome (satisfaction with the daily use of the hand) after 4 weeks (i and ii) and 8 weeks (ii).
- To document adherence to orthotic intervention from baseline to 4 weeks. We strive for 37 patients per arm and a total sample size of 74 patients per study group. This results in 74 patients in the extension-group and 74 patients in the flexion-group and a total of 148 patients enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The investigators plan to stratify participants into two groups based on their greater PIPJ movement deficit (in flexion or in extension). Within each group, they are randomized to one of the orthosis interventions. This trial has four intervention arms: * Arm 1: PIP extension deficit treated with an exercise RMF orthosis. * Arm 2: PIP extension deficit treated with a placebo RMF orthosis. * Arm 3: PIP flexion deficits treated with an exercise RME orthosis. * Arm 4: PIP flexion deficits treated with a placebo RMF orthosis.
| Arm | Type | Receives |
|---|---|---|
| PIP extension deficit treated with an exercise RMF orthosis | Experimental | Device: PIP extension deficit treated with an exercise RMF orthosisThe orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed. |
| PIP extension deficit treated with a placebo RMF orthosis | Placebo comparator | Device: PIP extension deficit treated with a placebo RMF orthosisThe orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed. |
| PIP flexion deficits treated with an exercise RME orthosis | Active comparator | Device: PIP flexion deficits treated with an exercise RME orthosisThe orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed. |
| PIP flexion deficits treated with a placebo RMF orthosis | Placebo comparator | Device: PIP flexion deficits treated with a placebo RMF orthosisThe orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PIPJ motion deficit with a minimum difference of 10° between passive and active motion
- To have an acute injury, i.e. operated on or within maximum 6 weeks of accident
- Only one hand is affected
- Adult patients over 18 years of age
- Understanding German, French or English
Key exclusion criteria (5 listed)
- Previous injuries to the hand or PIPJ (e.g., intra-articular fractures, PIPJ ligament damage) that may limit baseline joint mobility and influence responsiveness to the intervention.
- Presence of conditions such as osteoarthritis (OA) or rheumatoid arthritis (RA) that may affect PIPJ stiffness, pain, or inflammation.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia
- Boutonniere deformity
- Minors (below 18 years of age)
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 |
|---|---|---|
| PIP extension deficit treated with an exercise RMF orthosisThe RM orthoses will be worn between 6-12 hours per day during functional use. | Device | PIP extension deficit treated with an exercise RMF orthosis |
| PIP extension deficit treated with a placebo RMF orthosisThe placebo orthosis has the same design as the exercise RM orthoses, but without a difference in the extension or flexion angle, respectively, to the adjacent finger - therefore neutralizing the "quadriga phenomena", which is the effect that makes RM orthoses work. | Device | PIP extension deficit treated with a placebo RMF orthosis |
| PIP flexion deficits treated with a placebo RMF orthosisThe placebo orthosis have the same design as the exercise RM orthoses, but without a difference in the extension or flexion angle, respectively, to the adjacent finger - therefore neutralizing the "quadriga phenomena", which is the effect that makes RM orthoses work. | Device | PIP flexion deficits treated with a placebo RMF orthosis |
| PIP flexion deficits treated with an exercise RME orthosisThe dedicated orthosis wearing time is 6-12 hours per day during functional use. | Device | PIP flexion deficits treated with an exercise RME orthosis |
Primary outcome
Finger range of motion
Time frame: Change from baseline to 2, 4 and 6 weeks
PIPJ active and passive motion will be measured using a hand-held goniometer. The goniometer is placed dorsal to the joint in all cases with the arms of the goniometer aligned on the finger bones. The DIP, the PIP and MCP joints will be measured in both extension and flexion range of motion. The degrees of measurement will be noted using the neutral-zero method.
3 secondary outcomes
Patient satisfaction
Time frame: Change from baseline to 2, 4 and 8 weeks
Patient Specific Functional Scale (PSFS)
Time frame: Change from baseline to 4 and 8 weeks
Orthosis diary
Time frame: continuous
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 29 May 2025.
- Background: PubMed 22394534Glasgow C, Fleming J, Tooth LR, Peters S. Randomized controlled trial of daily total end range time (TERT) for Capener splinting of the stiff proximal interphalangeal joint. Am J Occup Ther. 2012 Mar-Apr;66(2):243-8. doi: 10.5014/ajot.2012.002816.
- Background: PubMed 22031594Horn KK, Jennings S, Richardson G, Vliet DV, Hefford C, Abbott JH. The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure. J Orthop Sports Phys Ther. 2012 Jan;42(1):30-42. doi: 10.2519/jospt.2012.3727. Epub 2011 Oct 25.
- Background: PubMed 22333510Hefford C, Abbott JH, Arnold R, Baxter GD. The patient-specific functional scale: validity, reliability, and responsiveness in patients with upper extremity musculoskeletal problems. J Orthop Sports Phys Ther. 2012 Feb;42(2):56-65. doi: 10.2519/jospt.2012.3953. Epub 2012 Feb 1.
- Background: PubMed 22170246Schreuders TA. The quadriga phenomenon: a review and clinical relevance. J Hand Surg Eur Vol. 2012 Jul;37(6):513-22. doi: 10.1177/1753193411430810. Epub 2011 Dec 14.
- Background: PubMed 37037728Shaw AV, Verma Y, Tucker S, Jain A, Furniss D. Relative motion orthoses for early active motion after finger extensor and flexor tendon repairs: A systematic review. J Hand Ther. 2023 Apr-Jun;36(2):332-346. doi: 10.1016/j.jht.2023.02.011. Epub 2023 Apr 8.
- Background: PubMed 36202676Arslan OB, Sigirtmac IC, Ayvali C, Bas CE, Ayhan E, Bilgin SS, Oksuz C. The Use of Relative Motion Flexion Orthoses for Chronic Boutonniere Deformity. J Hand Surg Am. 2024 May;49(5):488.e1-488.e8. doi: 10.1016/j.jhsa.2022.08.007. Epub 2022 Oct 4.
- Background: PubMed 37031058Yates SE, Glinsky JV, Hirth MJ, Fuller JT. The use of exercise relative motion orthoses to improve proximal interphalangeal joint motion: A survey of Australian hand therapy practice. J Hand Ther. 2023 Apr-Jun;36(2):414-424. doi: 10.1016/j.jht.2022.12.002. Epub 2023 Apr 6.
- Background: PubMed 37037730Arslan OB, Sahin Y, Sigirtmac IC, Yildiz B, Ayhan E, Oksuz C. Use of relative motion orthoses from the perspective of hand-injured patients: A qualitative study. J Hand Ther. 2023 Apr-Jun;36(2):425-432. doi: 10.1016/j.jht.2023.02.003. Epub 2023 Apr 8.
- Background: PubMed 36914489Howell JW, Ewald SG, Schwartz DA. Exercise relative motion orthoses: Use of the pencil test and variations of its use for assessing and managing different finger conditions. J Hand Ther. 2023 Apr-Jun;36(2):473-478. doi: 10.1016/j.jht.2022.10.004. Epub 2023 Mar 11. No abstract available.
- Background: PubMed 35039211Wajon S, Howell JW. Prescription of exercise relative motion orthoses to improve limited proximal interphalangeal joint movement: A prospective, multi-center, consecutive case series. J Hand Ther. 2023 Apr-Jun;36(2):378-388. doi: 10.1016/j.jht.2021.09.006. Epub 2022 Jan 14.
- Background: PubMed 15162100Michlovitz SL, Harris BA, Watkins MP. Therapy interventions for improving joint range of motion: A systematic review. J Hand Ther. 2004 Apr-Jun;17(2):118-31. doi: 10.1197/j.jht.2004.02.002.
- Background: PubMed 38278697Yates SE, Glinsky JV, Hirth MJ, Fuller JT. Orthotic interventions for restoring proximal interphalangeal joint motion for patients with hand injuries or conditions: A systematic review and meta-analysis. J Hand Ther. 2024 Oct-Dec;37(4):495-506. doi: 10.1016/j.jht.2023.12.018. Epub 2024 Jan 26.
- Individual participant dataSharing planned: No. We do not plan to publish our results in ICMJE journals.
Related trials for Proximal Interphalangeal Joint Stiffness
Recruiting
Pilot Study on The Effectiveness of Relative Motion Orthosis in Finger 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIP extension deficit treated with an exercise RMF orthosis and PIP flexion deficits treated with an exercise RME orthosis in people with Proximal Interphalangeal Joint Stiffness, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 7 inclusion and 5 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 29 May 2025. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 Bernadette Tobler-Ammann, PhD (+41 31 632 85 58, bernadette.tobler@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finger range of motion (time frame: Change from baseline to 2, 4 and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06985459, which also lists 13 linked publications.
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 29 May 2025.