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NCT01618227 · ClinicalTrials.gov registry record · NA
Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness
A NA study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT01618227: Clinical Trial NA study, sponsored by Massachusetts General Hospital.
NCT01618227 is a NA study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01618227, a NA study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
Loss of wrist flexion and extension is a common problem after wrist and forearm fractures that may lead to disability and unsatisfactory outcomes after fracture treatment. In many patients, this range of motion loss is caused by stiffness of the soft tissues. Such stiffness may loosen up and improve with rehabilitation. Static progressive splints apply a constant stretch upon the wrist resulting in a stretch relaxation and plastic deformation of the soft tissues. By altering the splint's bending angle, one can incrementally increase the force applied on either wrist flexion or extension. There are no data comparing rehabilitation with static-progressive splinting to rehabilitation without static-progressive splinting for the restoration of wrist flexion and extension after wrist or forearm fractures. Primary study hypothesis: Two months after study enrollment patients that use static progressive splinting have better wrist flexion and extension than patients that use standard therapy techniques. Secondary study hypotheses: 1. Six months after study enrollment, subjects that use static progressive splinting have better wrist flexion and extension than those that use standard therapy techniques. 2. Motion at enrollment, 2 months and 6 months after enrollment correlates with negative pain thoughts, pain anxiety, and depression. 3. Six months after study enrollment, subjects that use static progressive splinting have had fewer physical/occupational therapy visits than those that use standard therapy techniques. 4. Six months after study enrollment patients that use static progressive splinting have had fewer additional surgeries than patients that use standard therapy techniques. This study will employ a prospective randomized design. Subjects will be invited to enroll during their routine office follow-up visit. Informed consent will be obtained. Subjects will be randomized on a 1:1 ratio to rehabilitation with or without static progressive splinting. All subject
Interventions
- DEVICE Joint Active Systems (JAS) Static progressive splint
- PROCEDURE Rehabilitation without splinting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2008-09 |
| Est. Completion | 2015-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01618227
The ClinicalTrials.gov registry entry for NCT01618227 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Joint Active Systems (JAS) Static progressive splint is the first listed.
NCT01618227 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01618227 about?
NCT01618227 is a clinical study titled "Rehabilitation With or Without Static Progressive Splinting for Wrist Stiffness". Loss of wrist flexion and extension is a common problem after wrist and forearm fractures that may lead to disability and unsatisfactory outcomes after fracture treatment. In many patients, this range of motion loss is caused by stiffness of the soft tissues. Such stiffness may loosen up and improve...
What is the current status of trial NCT01618227?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2008-09. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01618227?
The interventions under investigation include: Joint Active Systems (JAS) Static progressive splint (DEVICE), Rehabilitation without splinting (PROCEDURE).
Who is sponsoring clinical trial NCT01618227?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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