Clinical trial NCT03555825: Burke-Hocoma Efficiency Study
Official title: Burke-Hocoma Efficiency Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemiparesis
Hemiplegia
Lead sponsor: Burke Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Hocoma
First posted: 2018-06-14
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: 60 minutes of Armeo treatment, 3 times per week for 6 weeks. (Half the patients will be assigned to 1:1 therapy and the other half to 2:1 therapy) Group 2: 30 minutes of Armeo treatment, 3 times per week for 6 weeks. (Half the patients will be assigned to 1:1 therapy and the other half to 2:1 therapy)
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Upper Extremity Fugl Meyer Assessment
timeFrame: Baseline, immediately after intervention, 3 month follow up
Secondary outcomes:
measure: Patient Satisfaction Survey/Enjoyment Scale
timeFrame: Baseline, immediately after intervention, 3 month follow up
measure: Box and Blocks Test
timeFrame: Baseline, immediately after intervention, 3 month follow up
measure: Grip Strength
timeFrame: Baseline, immediately after intervention, 3 month follow up
measure: Short Form Health Survey- 36
timeFrame: Baseline, immediately after intervention, 3 month follow up
measure: Stroke Impact Scale
timeFrame: Baseline, immediately after intervention, 3 month follow up
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Medical Research Institute
state: New York
Study officials:
affiliation: Burke Medical Research Institute
name: Tomoko Kitago, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wuennemann MJ, Mackenzie SW, Lane HP, Peltz AR, Ma X, Gerber LM, Edwards DJ, Kitago T. Dose and staffing comparison study of upper limb device-assisted therapy. NeuroRehabilitation. 2020;46(3):287-297. doi: 10.3233/NRE-192993.