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

Stroke Clinical Trial

Official title:

A Functional Upper Limb Training and Assessment Tool to Enhance Efficacy and Scalability of Rehabilitation in Ecological Environments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363944
• Other study ID #: 78849
• Secondary ID: 1R21HD092243
• Status: Completed
• Phase: N/A
• Start date: February 21, 2018
• Est. completion date: July 29, 2019

Study information

• Verified date: January 2024
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 29, 2019
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Individuals in the intervention all had a history of stroke.

Inclusion Criteria for feasibility study:

1. at least 18 years of age and living in the community

2. had a history of one stroke six or more months previous

3. had a minimum score of 124 on the Mattis Dementia Rating Scale (MDRS).

Exclusion Criteria for feasibility study:

1. acute or chronic pain that would interfere with participation

2. severely limited range of motion or contractures of shoulder, elbow, wrist or hand,

3. absent or severely impaired proprioception of the upper limb

4. musculoskeletal or circulatory conditions affecting the upper limb such as vascular disease, tendonitis, cellulitis, Raynaud's syndrome, or severe osteoarthritis or rheumatoid arthritis

5. spasticity graded as 3 or greater for upper extremity movement on the Modified Ashworth Scale (MAS)

6. botulinum toxin injections for spasticity management within three months of starting the study

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• mRehab
mRehab (mobile Rehab) was created to better support in-home upper limb rehabilitation programs. It incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items (a mug, bowl, key, and doorknob) integrated with a smartphone and an app. The app guides participants through practice of activities of daily living (ADL), for example, sipping from a mug. It can also consistently measure time to complete an activity and quality of movement (smoothness/accuracy) during the performance of ADLs. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data.

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repetitions Completed for Each Activity in the mRehab 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.	6 week in-home program
Primary	Time to Complete Activity in the mRehab Home Program	average time to complete an activity in the mRehab home program	last day of the 6 week in home program
Primary	Average Smoothness Per Activity in the mRehab 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.	last day of the 6 week in-home program
Secondary	Wolf Motor Function Test	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.	within 1 week of the completion of the in-home program
Secondary	Nine Hole Peg Test	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.	within 1 week of the end of the in-home program
Secondary	Difficulty Rating Scale	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.	within 1 - 3 weeks of the end of the program
Secondary	Systems Usability Scale (SUS)	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.	within 1-3 weeks of completion of home program
Secondary	mRehab Acceptance Questionnaire	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.	within 1-3 weeks of completion of the 6 week in-home program