Smartphone and 3D Printing Based Home Rehabilitation System for Chronic Stroke

Not Applicable

Completed

Conditions: Stroke

Interventions: Device: mRehab

Registration Number: NCT04363944

Lead Sponsor: State University of New York at Buffalo

Brief Summary: Interventions promoting optimum motor performance across the lifespan are a priority after a neurological insult such as stroke. The proposed research incorporates smart devices and 3D printing to create a patient-centered rehabilitation device, mRehab. This innovative blend of technology and principles of neuroplasticity can advance standards of practice in healthcare. In this feasibility study, it is hypothesized that individuals with chronic stroke can successfully use the portable rehabilitation unit, mRehab, at home with minimal oversight from the research team. Use of mRehab in a home based setting and functional changes in upper limb movement will be assessed.

Detailed Description: Impairments following stroke make it one of the leading causes of disability. Many individuals with stroke do not recover complete function of the upper limb at time of discharge from clinical services. Moreover, early stage improvements may wane following the cessation of formal therapies. Regaining as much upper limb function as possible is important, as even mild impairments are associated with limitations in daily function and lower health-related quality of life. The overarching purpose of this project is to use portable technology, affordable for home use, to provide objective feedback on performance of upper limb motor tasks to individuals with residual deficits following chronic conditions such as stroke. Objective feedback serves to better inform the participant of their progress and actively engage them in their rehabilitation, thus encouraging self-management of rehabilitation. Results from a recent survey shows therapists predominantly provide patients with stroke written home exercise programs at time of discharge from therapies. With this static approach, patients have a limited capacity to evaluate their motor performance and no encouragement to refine their movement. Smartphones were coupled with three-dimensional (3D) printed objects to create a home rehabilitation system, mRehab. The built-in sensors in smartphones and a custom app can quantify characteristics of movement and provide actionable feedback to users during in-home rehabilitation. It was hypothesized that 1) participants with stroke could use mRehab in a home program with minimal oversight and 2) use of mRehab would result in changes in functional movement.

Methodology: A single-subject experimental design with multiple baselines was used. A strength of the single-subject study design is that participants serve as their own control. Each participant had a varying length of the baseline and follow-up periods to establish that the intervention, rather than time, was the primary reason for any observed change in performance. Participants completed baseline measurements, a six-week mRehab home program, and follow-up measurements. Baseline measurements consisted of both in-lab and in-home measurements. Participants attended two lab visits prior to starting the home program to establish baselines on clinical assessments and to learn how to use mRehab. MRehab collected limited preliminary performance data without providing feedback during baseline. Participants then used mRehab in a six week home program receiving feedback on their performance each time they completed practice of an activity. At the completion of the home program participants completed follow up assessments that were similar to the baseline measurements. In addition, usability of mRehab was assessed.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mRehab	mRehab	Use of mRehab in a home program completing unilateral and bilateral activities. Participants are able to complete unilateral activities with their paretic arm/hand
mRehab completing all activities bilaterally	mRehab	Use of mRehab in a home program completing unilateral and bilateral activities. Participantsare can only complete intended unilateral activities using both hands

Primary Outcome Measures

Name	Time	Method
Time to Complete Activity in the mRehab Home Program	last day of the 6 week in home program	average time to complete an activity in the mRehab home program
Average Smoothness Per Activity in the mRehab Home Program	last day of the 6 week in-home program	The average smoothness per activity in mRehab on the first day of the 6 week home program. Using the acceleration readings from the inertial measurement unit embedded in the smartphone, a normalized jerk score which is dimensionless, allowing comparisons of movements that vary in duration and/or amplitude, can be computed. There are no set upper bounds for the score, as it is dependent on the smoothness. The minimum score is 0, which would indicate no jerk, or perfectly smooth movement. This measurement provides relative information for each movement as a normal range has not been established for each of the movements in this study. Overall, a lower score indicates smoother movement.
Repetitions Completed for Each Activity in the mRehab Home Program	6 week in-home program	The total number of repetitions each participant completed for each activity in mRehab during the 6 week home program was recorded. The average total number of repetitions completed for each activity is reported.

Secondary Outcome Measures

Name	Time	Method
Wolf Motor Function Test	within 1 week of the completion of the in-home program	The Wolf Motor Function Test (WMFT) is used to assess function of the upper extremity. The 17 item version of the WMFT was used. Tasks in the WMFT include tasks that assess gross motor activity (such as lifting hand/arm and placing it on a box), fine motor activity (such as picking up a paper clip) and strength. One timed task is a bilateral task (folding a towel). For timed tasks, participants are given up to 120 seconds to complete the task. If they cannot successfully complete it in that time they are given the max score of 120 seconds. In our papers we only use the timed tasks in the WMFT in our analyses. We report the average time to complete a task in the WMFT. A lower score indicates less time is required to complete the task.
mRehab Acceptance Questionnaire	within 1-3 weeks of completion of the 6 week in-home program	The mRehab (mobile Rehab) acceptance questionnaire was designed to assess the participants perception of the mRehab system we designed for this study. The questionnaire is based upon the Technology Acceptance model using a seven-point Likert scale - highly disagree (1) to highly agree (7)- for each question. Participants responded to 16 questions that probed the user's perceception of how they interacted with technology (3 questions) and their perceived usefulness, perceived ease of use, and behavioral intention to use the mRehab system in the future (13 questions). The total score is calculated as the sum of the response to each question. A score demonstrating the participant highly agreed that they would interact with technology and that they found mRehab useful, easy to use and that they would use in in the future would be 112. The minimum total score would be 16 (with a rating of highly disagree for each question). Higher scores would indicate better acceptance/interaction.
Systems Usability Scale (SUS)	within 1-3 weeks of completion of home program	A reliable tool for measuring usability. The Systems Usability Scale (SUS) consists of 10 questions, each rated on a 5-point Likert scale ranging from Strongly agree to Strongly disagree. The SUS was used to assess the participant's satisfaction with the mRehab system. A higher score represents a more positive perception of the device. A score of 50 would represent the strongest agreement that mRehab is a usable system. A score of 10 would represent the strongest disagreement that mRehab is a usable system.
Nine Hole Peg Test	within 1 week of the end of the in-home program	A timed clinical assessment used to measure finger dexterity. Lower times represent better performance. Participants place 9 pegs in 9 holes and then remove the pegs and place them in a container. The stop watch starts when the participant touches the first peg and stops when they place the last peg in the container. If participants could not complete placing the pegs in the holes they were given a score of 300 seconds.
Difficulty Rating Scale	within 1 - 3 weeks of the end of the program	A scale used to elicit user opinions on ease of use of the 3D printed objects (mug, bowl, key, and doorknob). It was a 7 point likert scale ranging from Very Difficult to Very Easy. The range was -3 to 3. A score of -3 represented the three-dimensional printed object was very difficult to use and a score of 3 representing the object was easy to use. The scores for the mug, bowl, key and door knob are included in the mean score given below.