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

NCT ID: NCT04363944

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-21
• Study Completion Date: 2019-07-29

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.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

mRehab

Intervention Type: DEVICE

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.

mRehab completing all activities bilaterally

Use of mRehab in a home program completing unilateral and bilateral activities. Participantsare can only complete intended unilateral activities using both hands

Group Type: EXPERIMENTAL

mRehab

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Jeanne Langan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeanne Langan, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

University at Buffalo

Buffalo, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33749608 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32706702 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21HD092243

Identifier Type: NIH

Identifier Source: secondary_id

View Link

78849

Identifier Type: -

Identifier Source: org_study_id