An interventional study of MoTrack Therapy in Hand Injuries, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-16.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Device feasibility
Among 27 studies in Hand Injuries with a site in United States — 8 open to participants now, 8 under way, none of them phase 3. Hand Injuries · United States.
Among the 27 studies in Hand Injuries with a site in United States, this one is the 19th largest by enrollment of the 26 interventional ones that give a count, is one of 5 that started in 2017, is one of 21 with no phase, and was the 10th registered.
122 studies on the registry are indexed under Hand Injuries; 35 are open to participants now.
Browse Hand Injuries studies →8 of the 27 studies in Hand Injuries with a site in United States are open now. Recruiting first, the newest first:
University of Washington · Sites in United States
Ages 22+
University of Missouri-Columbia · Sites in United States
Ages 18+ · Healthy volunteers
Cedars-Sinai Medical Center · Sites in United States
Ages 18–100
NYU Langone Health · Sites in United States
Ages 18–64
Johns Hopkins University · Sites in United States
Ages 18–100
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 26 Hand Injuries studies recruiting now, 14 (54%) set no upper age limit and 10 (38%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 1 · Phase 4 2
First in 2010; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 19 is below the median of 55 across 97 interventional studies indexed under Hand Injuries.
Median enrollment 30 across the 26 interventional studies, 60 across the 1 observational. Of the 15 that completed or were terminated, 3 (20%) have results posted.
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None of the 27 has an industry lead sponsor. The 10 most frequent:
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Johns Hopkins University has 3 studies filed under Hand Injuries — fewer than ten, so there is no comparison to draw.
2 of the studies in Hand Injuries with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05846399University of Missouri-ColumbiaCAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE) | 2027-07-01 |
| NCT07492797Mississippi State UniversityAccessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring | 2027-09-14 |
Among the 27 studies in Hand Injuries with a site in United States, from their registry updates:
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This study focuses on the use of a specific type of at-home hand rehabilitation software, MoTrack Therapy, in improving the treatment of hand and wrist injuries.
Compliance of patients to their prescribed at-home exercises is a large issue. To many patients, the exercises are seen as mundane and boring, decreasing the motivation of patients to complete their exercises. However, even when patients do complete their exercises, patients may have difficulty knowing whether the participants are doing their at-home exercises correctly and to the right amount. After leaving his or her therapist's office, the patient usually has nothing more than a written handout, if anything, to guide them through their at-home exercises. Especially since range of motion and pain levels can change daily, it is difficult to expect the patient to consistently do his or her exercises every time, much less to do them correctly. Ineffective exercises and / or a lack of compliance can lead to setbacks, complications, or even expensive and painful repeat surgeries. And at the therapist's office, the therapist may have trouble telling whether setbacks or lack of progress is because of lack of compliance, ineffective exercises, or an underlying medical problem.
Advances in technology have made it possible to track the hands of patients suffering from hand and wrist medical conditions as patients do their at-home exercises. Furthermore, this data can be analyzed in real-time to determine if and how the patient is doing his or her exercises. Another advantage of tracking the hand is that the therapy exercises can be incorporated into a fun computer game that motivates the patient to actually complete their therapy. The hypothesis is that having a computer and accompanying sensors track the hand to give real-time feedback, monitor improvements over time, and gamify the therapy experience to motivate the patient will improve the standard of care given to patients. If this hypothesis is true, patients will understand their exercises better, be inclined to do them more often, and thus have better outcomes. Not only will patients benefit, but the therapist's job will be easier as well. The therapist will have quantitative data to help distinguish medical issues from exercise issues. Ideally, a very successful trial would even suggest a possibility for the patient to rely less on the therapist for the at-home exercises, giving the therapist time to focus on more difficult cases. This research therefore is important because the problems with at-home therapy may be mitigated or solved with such an aid.
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EXCLUSION CRITERIA
Patients receive the MoTrack Therapy device to assist them in their at-home therapy exercises. The patient is instructed to use the MoTrack Therapy device when they want to do their at-home therapy exercises. The patients therapy in the clinic is not affected.
Device: MoTrack Therapy
A software that runs on a tablet or computer that reads information from a Universal Serial Bus external sensor and instructs patients in their exercises, giving patients feedback as necessary, and recording patient progress and activity.
Compliance
The software is able to record when the patient is using it, and thus will know how often patients are completing their exercises. The degree to which patients follow their therapist's recommended exercise schedule will be measured.
Time frame: At the conclusion of the patient's physical therapy (approximately 3 months after starting use of device)
Patient Ability to Understand the Prescribed Exercises From the Device
At therapy appointments during the study, patients will be asked to do the exercises with no visual or instructional aid in order to determine if they have learned to do the exercises correctly. If necessary, the patient will be given the software as an aid in order to determine if the patient is then able to complete the exercises.
Time frame: Approximately two weeks after patient starts to use the device
Prediction of Patient Improvement
Physical therapy should increase the patient's medical condition over time. In this outcome measure, the ability of the software to predict the patient's improvements in medical condition will be determined by comparing the software predictions of improvement with the actual patient improvements as determined by physical therapists. Medical condition in this case will be operationalized as the extent to which a patient can complete standard hand therapy exercises as measured by the therapist using goniometry.
Time frame: Approximately two weeks after patient starts to use the device
Prediction of Patient Improvement
Physical therapy should increase the patient's medical condition over time. In this outcome measure, the ability of the software to predict the patient's improvements in medical condition will be determined by comparing the software predictions of improvement with the actual patient improvements as determined by physical therapists. Medical condition in this case will be operationalized as the extent to which a patient can complete standard hand therapy exercises as measured by the therapist using goniometry.
Time frame: Approximately four weeks after patient starts to use the device
Prediction of Patient Improvement
Physical therapy should increase the patient's medical condition over time. In this outcome measure, the ability of the software to predict the patient's improvements in medical condition will be determined by comparing the software predictions of improvement with the actual patient improvements as determined by physical therapists. Medical condition in this case will be operationalized as the extent to which a patient can complete standard hand therapy exercises as measured by the therapist using goniometry.
Time frame: Approximately six weeks after patient starts to use the device
Prediction of Patient Improvement
Physical therapy should increase the patient's medical condition over time. In this outcome measure, the ability of the software to predict the patient's improvements in medical condition will be determined by comparing the software predictions of improvement with the actual patient improvements as determined by physical therapists. Medical condition in this case will be operationalized as the extent to which a patient can complete standard hand therapy exercises as measured by the therapist using goniometry.
Time frame: At the conclusion of the patient's physical therapy (approximately 3 months after the patient starts using the device)
Patient Hand Recovery
Using the bMHQ (Brief Michigan Hand Questionnaire), the patient's current state of the hand will be measured. The bMHQ is scored from 0-100, with higher scores indicating better functioning and satisfaction with the hand.The change in the survey results between the first baseline and subsequent measurement represents patient recovery.
Time frame: Baseline (defined as the therapist visit before the patient starts to use the device) and at the conclusion of the patient's physical therapy, approximately 3 months.
Patient Hand Recovery
Using the bMHQ (Brief Michigan Hand Questionnaire), the patient's current state of the hand will be measured. The bMHQ is scored from 0-100, with higher scores indicating better functioning and satisfaction with the hand.The change in the survey results between the first baseline and subsequent measurement represents patient recovery.
Time frame: Baseline (defined as the therapist visit before the patient starts to use the device) and at the halfway point in the patient's expected physical therapy, which is approximately 6 weeks after baseline
Patient Satisfaction
The patient will be asked "To what degree did you enjoy doing the exercises, and what feedback do you have for improving the app?". The patient's verbal responses will be recorded. The patient can also express their satisfaction to the investigators anytime during the study as they find criticism.
Time frame: At the end of the patient's physical therapy (approximately 3 months after starting use of device)
Therapist Satisfaction
The therapist will be asked "To what degree do you believe the MoTrack device is easy to use with your patients, and what feedback do you have for improving the app?". The therapist's verbal responses will be recorded. The therapist can also express their satisfaction to the investigators anytime during the study as they find criticism.
Time frame: At the end of the patient's physical therapy (approximately 3 months after starting use of device)
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Jun 2020, 31 months.
Of 59 non-industry interventional studies with no phase under Hand Injuries, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 26. This study's 31 months is above that.
Counting every sponsor, half of 59 studies reached it within 14 months; a quarter within 8 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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