Effectiveness of Exercise Relative Motion Orthoses for Limited Finger Joint Motion
NCT ID: NCT06985459
Last Updated: 2025-05-29
Study Results
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Basic Information
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RECRUITING
NA
148 participants
INTERVENTIONAL
2025-05-31
2028-05-31
Brief Summary
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Detailed Description
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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:
1. To evaluate if there is a clinically relevant difference in activity performance at 4 and 8 weeks after orthosis fabrication.
2. 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).
3. 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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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PIP extension deficit treated with an exercise RMF orthosis
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.
PIP extension deficit treated with an exercise RMF orthosis
The RM orthoses will be worn between 6-12 hours per day during functional use.
PIP extension deficit treated with a placebo RMF orthosis
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.
PIP extension deficit treated with a placebo RMF orthosis
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 an exercise RME orthosis
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.
PIP flexion deficits treated with an exercise RME orthosis
The dedicated orthosis wearing time is 6-12 hours per day during functional use.
PIP flexion deficits treated with a placebo RMF orthosis
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
PIP flexion deficits treated with a placebo RMF orthosis
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.
Interventions
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PIP extension deficit treated with an exercise RMF orthosis
The RM orthoses will be worn between 6-12 hours per day during functional use.
PIP extension deficit treated with a placebo RMF orthosis
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 orthosis
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 orthosis
The dedicated orthosis wearing time is 6-12 hours per day during functional use.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Bernadette Tobler
Head of hand therapy research unit
Locations
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University Hospital Bern
Bern, Canton of Bern, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Horn 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.
Hefford 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.
Schreuders 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.
Shaw 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.
Arslan 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.
Yates 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.
Arslan 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.
Howell 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.
Wajon 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.
Michlovitz 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.
Yates 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.
Kamnerdnakta 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.
Other Identifiers
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RM Orthosis Study 2025-00427
Identifier Type: -
Identifier Source: org_study_id
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