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NCT05888428 · ClinicalTrials.gov registry record · NA
Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
A NA study of Amputation and Upper Limb, sponsored by Infinite Biomedical Technologies.
- Recruiting
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05888428 is a NA study of Amputation and Upper Limb that is actively recruiting participants, run by Infinite Biomedical Technologies. The registered enrollment target is 16 participants, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05888428, a NA study of Amputation and Upper Limb, is actively recruiting participants, sponsored by Infinite Biomedical Technologies.
- RECRUITING
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose to evaluate the efficacy of MyoTrain in a prospective clinical study involving 16 individuals with trans-radial upper-limb loss over a period of 206 days. These individuals will be randomized to Group A (Control Group using standard motor imagery training) and Group B (who are provided the MyoTrain system). The investigators will test three hypotheses: 1. The use of MyoTrain results in skills transference to control of the final prosthesis 2. The virtual outcome measures in MyoTrain are correlated with real-world functional outcome measures 3. The use of MyoTrain results in improved clinical outcomes as measured by functional, subjective and usage metrics Following a baseline functional assessment, participants will undergo a 30-day pre-prosthetic training period specific to their assigned Group. After this training period, participants will receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo clinical assessment. Post-device delivery, participants will then complete 3 56-day blocks of at-home prosthesis use, in between which they will return to clinic for assessment.
Conditions Studied
Interventions
- DEVICE MyoTrain
- BEHAVIORAL Motor Imagery
Study Locations (1)
Michigan
- Hanger Clinic - Grand Rapids - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-02-02 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05888428
The ClinicalTrials.gov registry entry for NCT05888428 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (88% lower). The listed sponsor is Infinite Biomedical Technologies, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Amputation appearing as the primary indexed condition, and to 2 interventions - of which MyoTrain is the first listed.
NCT05888428 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT05888428 about?
NCT05888428 is a clinical study titled "Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss". The investigators propose to evaluate the efficacy of MyoTrain in a prospective clinical study involving 16 individuals with trans-radial upper-limb loss over a period of 206 days. These individuals will be randomized to Group A (Control Group using standard motor imagery training) and Group B (who ...
What is the current status of trial NCT05888428?
This trial is currently recruiting. It is a NA study. The enrollment target is 16 participants. The study started on 2024-02-02. Estimated completion is 2026-08-31.
What conditions does trial NCT05888428 study?
This clinical trial studies the following conditions: Amputation, Upper Limb.
What interventions are being tested in trial NCT05888428?
The interventions under investigation include: MyoTrain (DEVICE), Motor Imagery (BEHAVIORAL).
Who is sponsoring clinical trial NCT05888428?
This trial is sponsored by Infinite Biomedical Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05888428 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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