NCT03345693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

November 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2020

Completed
Last Updated

March 16, 2021

Status Verified

July 1, 2020

Enrollment Period

2.6 years

First QC Date

November 8, 2017

Last Update Submit

March 12, 2021

Conditions

Keywords

RehabilitationMoTrack TherapyTelemedicineComputer VisionCompliance

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Approximately two weeks after patient starts to use the device

  • Prediction of Patient Improvement

    Approximately two weeks after patient starts to use the device

  • Prediction of Patient Improvement

    Approximately four weeks after patient starts to use the device

  • Prediction of Patient Improvement

    Approximately six weeks after patient starts to use the device

  • Prediction of Patient Improvement

    At the conclusion of the patient's physical therapy (approximately 3 months after the patient starts using the device)

  • +4 more secondary outcomes

Study Arms (1)

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.

Device: MoTrack Therapy

Interventions

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.

Treated with MoTrack Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Conditions

Hand InjuriesPatient Compliance

Condition Hierarchy (Ancestors)

Wounds and InjuriesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Scott S Lifchez, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 17, 2017

Study Start

November 10, 2017

Primary Completion

June 11, 2020

Study Completion

June 11, 2020

Last Updated

March 16, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations