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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mRehab
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring home programs, assistive technology, rehabilitation

Eligibility Criteria

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

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

Sites / Locations

  • University at Buffalo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mRehab

Arm Description

Use of mRehab in a home program

Outcomes

Primary Outcome Measures

Repetitions completed for each activity in the mRehab home program
number of repetitions
Time to complete activity in the mRehab home program
average time to complete an activity
Average smoothness per activity in the mRehab home program
average smoothness for each activity: Using the sensors in the smartphone, the custom mRehab app will record smoothness of movement represented as a normalized cumulative jerk (rate of change of acceleration) score.

Secondary Outcome Measures

Wolf Motor Function Test
Clinical assessment that assesses upper limb motor ability through timed functional tasks. Lower times represent better performance.
Nine hole peg test
A timed clinical assessment used to measure finger dexterity. Lower times represent better performance.
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.
Systems Usability Scale (SUS)
A reliable tool for measuring usability. Participants respond to questions 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.
mRehab acceptance questionnaire
Based on the Technology Acceptance model it uses a seven-point Likert scale - highly disagree to highly agree. Questions probed user's perceived usefulness, perceived ease of use, and behavioral intention to use the mRehab system in the future.

Full Information

First Posted
April 16, 2020
Last Updated
April 24, 2020
Sponsor
State University of New York at Buffalo
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04363944
Brief Title
Smartphone and 3D Printing Based Home Rehabilitation System for Chronic Stroke
Official Title
A Functional Upper Limb Training and Assessment Tool to Enhance Efficacy and Scalability of Rehabilitation in Ecological Environments
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
July 29, 2019 (Actual)
Study Completion Date
July 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
home programs, assistive technology, rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The purpose of the intervention was to provide proof of concept that it is feasible for individuals with stroke to use mRehab in a home program and to examine if changes in motor function were enhanced following the home program.
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRehab
Arm Type
Experimental
Arm Description
Use of mRehab in a home program
Intervention Type
Device
Intervention Name(s)
mRehab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Repetitions completed for each activity in the mRehab home program
Description
number of repetitions
Time Frame
through study completion, 10 weeks
Title
Time to complete activity in the mRehab home program
Description
average time to complete an activity
Time Frame
through study completion, 10 weeks
Title
Average smoothness per activity in the mRehab home program
Description
average smoothness for each activity: Using the sensors in the smartphone, the custom mRehab app will record smoothness of movement represented as a normalized cumulative jerk (rate of change of acceleration) score.
Time Frame
through study completion, 10 weeks
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
Clinical assessment that assesses upper limb motor ability through timed functional tasks. Lower times represent better performance.
Time Frame
week 1, approximately week 2 and week 8, and week 10
Title
Nine hole peg test
Description
A timed clinical assessment used to measure finger dexterity. Lower times represent better performance.
Time Frame
week 1, approximately week 2 and week 8, and week 10
Title
Difficulty rating Scale
Description
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.
Time Frame
week 10
Title
Systems Usability Scale (SUS)
Description
A reliable tool for measuring usability. Participants respond to questions 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.
Time Frame
week 10
Title
mRehab acceptance questionnaire
Description
Based on the Technology Acceptance model it uses a seven-point Likert scale - highly disagree to highly agree. Questions probed user's perceived usefulness, perceived ease of use, and behavioral intention to use the mRehab system in the future.
Time Frame
week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Individuals in the intervention all had a history of stroke. Inclusion Criteria for feasibility study: at least 18 years of age and living in the community had a history of one stroke six or more months previous had a minimum score of 124 on the Mattis Dementia Rating Scale (MDRS). Exclusion Criteria for feasibility study: acute or chronic pain that would interfere with participation severely limited range of motion or contractures of shoulder, elbow, wrist or hand, absent or severely impaired proprioception of the upper limb musculoskeletal or circulatory conditions affecting the upper limb such as vascular disease, tendonitis, cellulitis, Raynaud's syndrome, or severe osteoarthritis or rheumatoid arthritis spasticity graded as 3 or greater for upper extremity movement on the Modified Ashworth Scale (MAS) botulinum toxin injections for spasticity management within three months of starting the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne Langan, PT, PhD
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The final dataset will include self-reported demographic information (such as age and gender) cognitive assessments, motor performance on clinical assessments and data collected during rehabilitation from mRehab.
IPD Sharing Time Frame
The IPD will be provided following acceptance of manuscripts.
Citations:
PubMed Identifier
33749608
Citation
Bhattacharjya S, Cavuoto LA, Reilly B, Xu W, Subryan H, Langan J. Usability, Usefulness, and Acceptance of a Novel, Portable Rehabilitation System (mRehab) Using Smartphone and 3D Printing Technology: Mixed Methods Study. JMIR Hum Factors. 2021 Mar 22;8(1):e21312. doi: 10.2196/21312.
Results Reference
derived
PubMed Identifier
32706702
Citation
Langan J, Bhattacharjya S, Subryan H, Xu W, Chen B, Li Z, Cavuoto L. In-Home Rehabilitation Using a Smartphone App Coupled With 3D Printed Functional Objects: Single-Subject Design Study. JMIR Mhealth Uhealth. 2020 Jul 22;8(7):e19582. doi: 10.2196/19582.
Results Reference
derived

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

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