StrokeNCT04363944
Smartphone and 3D Printing Based Home Rehabilitation System for Chronic Stroke
A study testing mRehab in people with Stroke, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- mRehab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2018to 29 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Functional Upper Limb Training and Assessment Tool to Enhance Efficacy and Scalability of Rehabilitation in Ecological Environments
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- mRehab
- Keywords
- home programs, assistive technology, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRehabDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| mRehab | Experimental | Use of mRehab in a home program completing unilateral and bilateral activities. Participants are able to complete unilateral activities with their paretic arm/hand Receives: Device: mRehab |
| mRehab completing all activities bilaterally | Experimental | Use of mRehab in a home program completing unilateral and bilateral activities. Participantsare can only complete intended unilateral activities using both hands Receives: Device: mRehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 week in-home program
Time to Complete Activity in the mRehab Home Program
average time to complete an activity in the mRehab home program
Measured: last day of the 6 week in home program
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.
Measured: last day of the 6 week in-home program
Secondary outcomes (5)
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.
Measured: within 1 week of the completion of the in-home program
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.
Measured: within 1 week of the end of the in-home program
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.
Measured: within 1 - 3 weeks of the end of the program
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.
Measured: within 1-3 weeks of completion of home program
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.
Measured: within 1-3 weeks of completion of the 6 week in-home program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start21 Feb 2018
- Primary completion29 Jul 2019
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jeanne Langan, State University of New York at Buffalo
- Investigators
- Jeanne Langan, PT, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363944
- Sponsor's protocol ID
- 78849
- Other IDs
- 1R21HD092243
- Status last verified
- Jan 2024
- First submitted
- 16 Apr 2020
- Last updated
- 23 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33749608Langan 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.
PubMed 32706702
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Functional Upper Limb Training and Assessment Tool to Enhance Efficacy and Scalability of Rehabilitation in Ecological Environments
- ClinicalTrials.gov ID
- NCT04363944
- Acronym / sponsor ID
- 78849
- Conditions
- Stroke
- Keywords
- home programs, assistive technology, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Posted 23 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| mRehab | Experimental | Device: mRehabUse 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 | Experimental | Device: mRehabUse of mRehab in a home program completing unilateral and bilateral activities. Participantsare can only complete intended unilateral activities using both hands |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRehabmRehab (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. | Device | mRehab, mRehab completing all activities bilaterally |
Primary outcome
Repetitions Completed for Each Activity in the mRehab Home Program
Time frame: 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.
Time to Complete Activity in the mRehab Home Program
Time frame: 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
Time frame: 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.
5 secondary outcomes
Wolf Motor Function Test
Time frame: within 1 week of the completion of the in-home program
Nine Hole Peg Test
Time frame: within 1 week of the end of the in-home program
Difficulty Rating Scale
Time frame: within 1 - 3 weeks of the end of the program
Systems Usability Scale (SUS)
Time frame: within 1-3 weeks of completion of home program
mRehab Acceptance Questionnaire
Time frame: within 1-3 weeks of completion of the 6 week in-home program
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33749608Bhattacharjya 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.
- Derived from this study: PubMed 32706702Langan 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne Langan, PT, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mRehab in people with Stroke, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repetitions Completed for Each Activity in the mRehab Home Program (time frame: 6 week in-home program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04363944, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.