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NCT05311384 · ClinicalTrials.gov registry record · NA
Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT05311384 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 10 participants.
The verdict
NCT05311384, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
CI therapy is a family of techniques that has systematically applied intensive treatment daily over consecutive days, supervised motor training using a technique called shaping, behavioral strategies to improve the use of the more- affected limb in real life situations called a Transfer Package (TP), and strategies to remind participants to use the more-affected extremity; including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining use of CI therapy with UE rehabilitation have demonstrated robust evidence for increasing the amount and the quality of the paretic UE functional use in daily situations of individuals recovering from stroke. Previous studies have explored the barriers for clinical implementation of the approach, including the amount of time needed by therapists, other resources required and lack of payment for the services. With regards to therapists' time/resources, in the signature CI therapy protocol, therapists supervised movement training for 3 hours daily (except for weekends) for a 12 consecutive-day period. This level of supervision in highly unusual for traditional rehabilitation clinical settings. The treatment schedule is also incompatible with most insurance reimbursement policies in the US. As such, most CI therapy clinics require patients to pay privately with little or no insurance reimbursement. Such practices severely limit the number of patients who can afford to receive CI therapy. Two lines of evidence have suggested that an alternative CI therapy protocol may allow for the essential (or "Key") CI therapy elements to be delivered in a schedule that better utilizes therapist time/resources and is compatible with payment policies of many US insurance companies. One line of evidence comes from findings that indicate that the original 6-hour supervised training schedule could be shortened to as little as 2-hours/daily without a reduction in outcomes. Additional evidence comes from a study
Interventions
- BEHAVIORAL Keys Constraint-induced Movement Therapy protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-04-20 |
| Est. Completion | 2024-02-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05311384
The ClinicalTrials.gov registry entry for NCT05311384 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Keys Constraint-induced Movement Therapy protocol is the first listed.
NCT05311384 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05311384 about?
NCT05311384 is a clinical study titled "Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity". CI therapy is a family of techniques that has systematically applied intensive treatment daily over consecutive days, supervised motor training using a technique called shaping, behavioral strategies to improve the use of the more- affected limb in real life situations called a Transfer Package (TP)...
What is the current status of trial NCT05311384?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2022-04-20. Estimated completion is 2024-02-01.
What interventions are being tested in trial NCT05311384?
The interventions under investigation include: Keys Constraint-induced Movement Therapy protocol (BEHAVIORAL).
Who is sponsoring clinical trial NCT05311384?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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