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

University at Buffalo (UB)

Status: Completed

Conditions: Stroke

Treatments: Device: mRehab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04363944

78849

1R21HD092243 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

mRehab

Experimental group

Description:

Use of mRehab in a home program completing unilateral and bilateral activities. Participants are able to complete unilateral activities with their paretic arm/hand

Treatment:

Device: mRehab

mRehab completing all activities bilaterally

Experimental group

Description:

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

Treatment:

Device: mRehab