Hand InjuriesNCT03345693
Use of MoTrack Therapy in At-Home Hand Rehabilitation
A study testing MoTrack Therapy in people with Hand Injuries, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injuries
- What is being tested?
- MoTrack Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2017to 11 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with hand and wrist conditions that require at-home exercises of wrist/finger movements, including dorsiflexion, palmar flexion, radial deviation, ulnar deviation, supination, pronation, thumb adduction, etc.
- Participants who have fractures and similar conditions as the cause of the problem
- Participants must be able to give their own consent.
Who cannot join
- Pregnant women
- Participants not fluent in English
- Participants below the age of 18
- Participants institutionalized or incarcerated
- Participants who's hand condition is primarily nerve-related as opposed to being caused by a fracture or similar condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Use of Assistive At--Home Hand- Tracking Technology, MoTrack Therapy, in Hand Rehabilitation
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.
Read the detailed description
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.
- Conditions
- Hand Injuries
- Being tested
- MoTrack Therapy
- Keywords
- Rehabilitation, MoTrack Therapy, Telemedicine, Computer Vision, Compliance
- Medical subject headings
- Hand Injuries, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoTrack TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treated with MoTrack Therapy | Experimental | 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. Receives: Device: MoTrack Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the conclusion of the patient's physical therapy (approximately 3 months after starting use of device)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of the patient's physical therapy (approximately 3 months after starting use of device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start10 Nov 2017
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott S Lifchez, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345693
- Sponsor's protocol ID
- IRB00106559
- Status last verified
- Jul 2020
- First submitted
- 8 Nov 2017
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Use of Assistive At--Home Hand- Tracking Technology, MoTrack Therapy, in Hand Rehabilitation
- ClinicalTrials.gov ID
- NCT03345693
- Acronym / sponsor ID
- IRB00106559
- Conditions
- Hand Injuries
- Keywords
- Rehabilitation, MoTrack Therapy, Telemedicine, Computer Vision, Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with MoTrack Therapy | Experimental | Device: MoTrack TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with hand and wrist conditions that require at-home exercises of wrist/finger movements, including dorsiflexion, palmar flexion, radial deviation, ulnar deviation, supination, pronation, thumb adduction, etc.
- Participants who have fractures and similar conditions as the cause of the problem
- Participants must be able to give their own consent.
Key exclusion criteria (5 listed)
- Pregnant women
- Participants not fluent in English
- Participants below the age of 18
- Participants institutionalized or incarcerated
- Participants who's hand condition is primarily nerve-related as opposed to being caused by a fracture or similar condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoTrack TherapyA 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. | Device | Treated with MoTrack Therapy |
Primary outcome
Compliance
Time frame: At the conclusion of the patient's physical therapy (approximately 3 months after starting use of device)
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.
9 secondary outcomes
Patient Ability to Understand the Prescribed Exercises From the Device
Time frame: Approximately two weeks after patient starts to use the device
Prediction of Patient Improvement
Time frame: Approximately two weeks after patient starts to use the device
Prediction of Patient Improvement
Time frame: Approximately four weeks after patient starts to use the device
Prediction of Patient Improvement
Time frame: Approximately six weeks after patient starts to use the device
Prediction of Patient Improvement
Time frame: At the conclusion of the patient's physical therapy (approximately 3 months after the patient starts using the device)
Patient Hand 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
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
Time frame: At the end of the patient's physical therapy (approximately 3 months after starting use of device)
Therapist Satisfaction
Time frame: At the end of the patient's physical therapy (approximately 3 months after starting use of device)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott S Lifchez, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoTrack Therapy in people with Hand Injuries, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: At the conclusion of the patient's physical therapy (approximately 3 months after starting use of device)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.