An interventional study of Elastic Tension Digital Neoprene Orthosis in Proximal Interphalangeal Finger Joint Contractures, sponsored by Vicenç Punsola Izard. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by Vicenç Punsola Izard · Not applicable, Interventional, and Treatment
Elastic Tension Digital Neoprene Orthosis is a new device that can increase the dose of treatment of the proximal interphalangeal flexion contractures. This treatment improved the results in extension and also reducing the time to obtain it.
Question: In fingers with proximal interphalangeal joint flexion contractures, do significant differences exist between the passive range of motion improvement achieved in joints that receive higher doses of daily total end range time compared to those that receive lower doses of daily total end range time?
Design: Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat
Participants: Fifty-seven fingers in fifty patients suffering a proximal interphalangeal joint flexion contracture
Intervention: The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate extension. Researchers applied two different daily total end range time doses. Group A patients used the orthosis with a dose of twenty to twenty-two hours of daily total end range time while group B patients used the elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours. The exercise program was the same for both groups.
Outcome measures: The researchers performed the goniometric measurements manually twice at the beginning of every session during the three-week period. The first measurement was at the patient arrival after a preconditioning and the second was after twenty minutes. This measurement at the first session was included as a Modified weeks test while at the second, third and forth session was recorded as a contraction test. Patient report of orthosis wear time and
79 studies on the registry are indexed under Contracture; 18 are open to participants now.
This study's enrollment of 91 is above the median of 33 across 62 interventional studies indexed under Contracture.
Browse Contracture studies →Vicenç Punsola Izard is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Patient Inclusion Criteria:
Exclusion Criteria:
used the elastic tension digital neoprene orthosis from twenty to twenty-two hours
Device: Elastic Tension Digital Neoprene Orthosis
used the elastic tension digital neoprene orthosis from eleven to thirteen hours
Device: Elastic Tension Digital Neoprene Orthosis
The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate two different daily total end range time doses. Group A patients used a dose of twenty to twenty-two hours of daily total end range time while group B patients used the extension elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours for a mean of twenty hours a day. The exercise program was the same for both groups.
Change in the proximal interphalangeal joint extension
difference in passive finger extension between the first day and the seventh day
Time frame: 7 days
Change in the proximal interphalangeal joint extension
difference in passive finger extension between the first day and the twenty first day
Time frame: 21 days
- Modified Weeks Test
Difference in finger extension at the beginning of te session and after a 15 min passive assisted extension exercise with a force of 500g
Time frame: fifteen minutes
- Contraction Test
Finger reaction at release of the orthosis
Time frame: 21 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2020 to primary completion in Jun 2021, 7 months.
Of 30 interventional studies with no phase under Contracture, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 55. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Vicenç Punsola Izard