Stroke, Acute
Conditions
Brief summary
The purpose of this study is to assess the safety, reliability, and efficacy of the use of the Harmony Scapulohumeral Rhythm (SHR) upper extremity robotic rehabilitation system for persons with impaired functional use of one or both upper extremities due to stroke.
Detailed description
Once recruited, subjects will be randomly assigned to traditional or intervention groups. Subjects in the traditional therapy group will receive up to 24 sessions of traditional occupational therapy intervention focusing on upper limb task training. Subjects in the intervention group will receive up to 24 sessions of functional task training using the Harmony SHR device. These sessions will be conducted by a trained researcher or licensed occupational therapist. Outcome measures will be assessed prior to the first intervention session and following the last intervention session, prior to discharge from inpatient rehabilitation.
Interventions
DEVICEHarmony SHR
Functional task training with use of Harmony SHR device
Functional task training of affected limb
Sponsors
Shirley Ryan AbilityLab
Harmonic Bionics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One group will receive traditional occupational therapy while the other group will receive occupational therapy with use of the Harmony SHR device.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Limited or impaired functional use of one or both upper extremities due to stroke * Currently admitted to the Shirley Ryan AbilityLab as an inpatient * Minimum passive Range of Motion requirements as follows: * Shoulder flexion: 90⁰ minimum with zero starting point of arm perpendicular to the floor and 90⁰ measuring at a right angle parallel to the floor in the sagittal plane * Shoulder abduction: 90⁰ minimum with zero starting point of arm perpendicular to the floor and 90⁰ measuring at a right angle parallel to the floor in the coronal/frontal plane * Shoulder rotation: tolerating of don/doff position, depending on the degree of ER required for that position * Elbow flexion: 90⁰ minimum with zero starting point of arm perpendicular to the floor and 90⁰ measuring at a right angle parallel to the floor in the sagittal plane * Wrist pronation: 0⁰ minimum with the zero starting point of the forearm in neutral with the palm of the hand pointing inward and the thumb pointing up, perpendicular to the floor * Have skeletal measurements within the ranges specified: * Seated shoulder height in range of 840 mm to 1122 mm measured as the sum of the following: * Seat of chair to acromion process of seated patient * Height of the chair * Shoulder Breadth in the range of 324mm to 443mm measured between the acromion process in one scapula to the acromion process on the other scapula * Humeral length in the range of 250mm to 350mm measured between the greater tubercle to lateral epicondyle * Ulnar length in the range of 228 mm to 306 mm measured between the olecranon to head of ulna/styloid process * 21 years of age or older * Ability to safely transfer from mobility device to standard chair with no armrests or with the assistance of a licensed occupational therapist/trained research staff * Able and willing to give written consent and comply with study procedures
Exclusion criteria
* Pregnant * Pressure injury or exposed broken skin at sites of contact with device * History of mastectomy and/or axillary lymph node resection or history of active lymphedema in upper extremity * Recent sternotomy/active sternal precautions * Recent pacemaker/ICD placement with active pacemaker precautions * Inability to tolerate upright position and traditional therapy outside of the device * Spasticity \>3 on the Modified Ashworth Scale (MAS) * Medical line (e.g., IV, PICC, dialysis port) at contact points * Heterotrophic ossification * Unresolved deep vein thrombosis * Fixed joint contractures that limit movement required to use device * Inability to express pain/discomfort * Presence of a condition that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremity Fugl-Meyer Assessment (UE FMA) | Prior to intervention start, day 1, and prior to discharge from inpatient rehabilitation (on average day 21) and the change in score will be recorded. | The Upper Extremity Fugl-Meyer Assessment (UE FMA) is a 33 item stroke-specific, performance-based impairment index designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. For the purposes of this study, only the upper extremity motor functioning domain will be assessed. This domain is comprised of assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. Scoring is based on direct observation of performance and items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0 = cannot perform, 1 = performs partially, and 2 = performs fully. Total score range is from 0 to 66, with a higher total score indicates less impairment of the UE being tested. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test (ARAT) | Prior to intervention start, day 1, and prior to discharge from inpatient rehabilitation (on average day 21) and the change in score will be recorded | The Action Research Arm Test (ARAT) is a 19 item observational measure used to assess upper extremity performance (coordination, dexterity, and functioning) in stroke recovery, brain injury, and multiple sclerosis. Items comprising the ARAT are categorized into 4 subscales (grasp, grip, pinch, gross motor) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Score ranges from 0-57. Higher total score indicates more function of the UE being tested. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORArun Jayaraman, PT, PhD
Shirley Ryan AbilityLab
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized | 61.9 years |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black/African American | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 8 Participants |
| Race/Ethnicity, Customized Ethnicity - Hispanic | 0 Participants |
| Race/Ethnicity, Customized Ethnicity - non-Hispanic | 19 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 1 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 1 | 0 / 10 | 0 / 10 |
Outcome results
None listed