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

NCT04363944 | Completed Results

• 2 other identifiers: 788491R21HD092243
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

home programs; assistive technology; rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Wolf Motor Function Test

  within 1 week of the completion of the in-home program

• Nine Hole Peg Test

  within 1 week of the end of the in-home program

• Difficulty Rating Scale

  within 1 - 3 weeks of the end of the program

• Systems Usability Scale (SUS)

  within 1-3 weeks of completion of home program

• mRehab Acceptance Questionnaire

  within 1-3 weeks of completion of the 6 week in-home program

Study Arms (2)

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

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

Device: mRehab

Interventions

mRehab 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; mRehab completing all activities bilaterally

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (2)

• 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.

  PMID: 33749608 DERIVED

• 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.

  PMID: 32706702 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Jeanne Langan
• Organization: University at Buffalo

jlangan@buffalo.edu

17168292905

Study Officials

• Jeanne Langan, PT, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 27, 2020
• Study Start: February 21, 2018
• Primary Completion: July 29, 2019
• Study Completion: July 29, 2019
• Last Updated: January 23, 2024
• Results First Posted: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: The IPD will be provided following acceptance of manuscripts.
• Access Criteria: Individual participant data (IPD) will be provided for the primary and secondary outcomes of the study. Data will be available in June 2022 and will continue to be available for 2 years, June 2024. The IPD may be accessed by the URL: https://cse.buffalo.edu/\~wenyaoxu/project/mRehab\ Data.xlsx

Locations

US (1)