Burke-Hocoma Efficiency Study

Burke Medical Research Institute

Status and phase: Completed; Phase 3

Conditions: Hemiparesis; Hemiplegia

Treatments: Device: Hocoma ArmeoSpring

Study type: Interventional

Funder types: Other

Identifiers

NCT03555825

BRC540

Details and patient eligibility

About

The ArmeoSpring device is an exoskeleton (3 joints and 6 degrees of freedom) with integrated springs. The investigators hypothesize that 3 days of training for 6 weeks with the Hocoma Armeo Spring device will be efficient and more effective than one on one ArmeoSpring therapy.

Full description

In the proposed study, 20 stable subacute and chronic stroke patients will be placed in two groups: 2:1 treatment for 3 weeks (2 patients on 2 robots with one therapist; 60 minutes on robot) then 1 on 1 intervention with the therapist (60 minutes of Hocoma Armeo Spring robotic training) or visa versa. Patients will be assessed using robotic kinematics and standardized occupational therapy motor assessments. The extreme precision afforded by robotic physical rehabilitation therapies makes them an appealing and growing field in rehabilitation.

Determining efficiency of new technologies, while maintaining the highest quality of care, is of priority in the medical field at this time. Devices such as the ArmeoSpring could lead to reduced disability, thereby increasing function and improving quality of life in patients experiencing neurological illness or injury. The ArmeoSpring has potential to decrease cost for both the provider and patient over time while providing more engaging, evidence-based therapy.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral or bilateral upper extremity hemiparesis/hemiplegia
• Upper extremity Fugl-Meyer Assessment Score between 7-60 (Neither hemiplegic nor fully recovered motor function of the shoulder, elbow, wrist)

Exclusion criteria

• Inability to follow 1-2 step commands
• Fixed joint contracture
• Unable to tolerate repetitious movement exhibited by pain greater than 5 on Likert Scale
• Any device dependent restrictions

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 4 patient groups

60 Minutes ArmeoSpring (1:1)

Active Comparator group

Description:

60 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session.

Treatment:

Device: Hocoma ArmeoSpring

60 Minutes ArmeoSpring (2:1)

Experimental group

Description:

60 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants.

Treatment:

Device: Hocoma ArmeoSpring

30 Minutes ArmeoSpring (1:1)

Active Comparator group

Description:

30 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session.

Treatment:

Device: Hocoma ArmeoSpring

30 Minutes ArmeoSpring (2:1)

Experimental group

Description:

30 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants.

Treatment:

Device: Hocoma ArmeoSpring