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Use of MoTrack Therapy in At-Home Hand Rehabilitation

Primary Purpose

Hand Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MoTrack Therapy
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Hand Injuries focused on measuring Rehabilitation, MoTrack Therapy, Telemedicine, Computer Vision, Compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

  • 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.

EXCLUSION CRITERIA

  • 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

Sites / Locations

  • Johns Hopkins Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated with MoTrack Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 8, 2017
Last Updated
March 12, 2021
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03345693
Brief Title
Use of MoTrack Therapy in At-Home Hand Rehabilitation
Official Title
Analysis of the Use of Assistive At--Home Hand- Tracking Technology, MoTrack Therapy, in Hand Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
June 11, 2020 (Actual)
Study Completion Date
June 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries
Keywords
Rehabilitation, MoTrack Therapy, Telemedicine, Computer Vision, Compliance

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treated with MoTrack Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MoTrack Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compliance
Description
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)
Secondary Outcome Measure Information:
Title
Patient Ability to Understand the Prescribed Exercises From the Device
Description
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
Title
Prediction of Patient Improvement
Description
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
Title
Prediction of Patient Improvement
Description
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
Title
Prediction of Patient Improvement
Description
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
Title
Prediction of Patient Improvement
Description
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)
Title
Patient Hand Recovery
Description
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.
Title
Patient Hand Recovery
Description
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
Title
Patient Satisfaction
Description
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)
Title
Therapist Satisfaction
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA 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. EXCLUSION CRITERIA 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott S Lifchez, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of MoTrack Therapy in At-Home Hand Rehabilitation

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