Burke-Hocoma Efficiency Study

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegia; Hemiparesis
• Intervention / Treatment: Device: Hocoma ArmeoSpring

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10605
      • Burke Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 60 Minutes ArmeoSpring (1:1); 60 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session.	Device: Hocoma ArmeoSpring; A spring-loaded upper extremity exoskeleton with 3 joints and 6 degrees of freedom. Participants use the more affected upper extremity to control and engage in therapeutic games.
Experimental: 60 Minutes ArmeoSpring (2:1); 60 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants.	Device: Hocoma ArmeoSpring; A spring-loaded upper extremity exoskeleton with 3 joints and 6 degrees of freedom. Participants use the more affected upper extremity to control and engage in therapeutic games.
Active Comparator: 30 Minutes ArmeoSpring (1:1); 30 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session.	Device: Hocoma ArmeoSpring; A spring-loaded upper extremity exoskeleton with 3 joints and 6 degrees of freedom. Participants use the more affected upper extremity to control and engage in therapeutic games.
Experimental: 30 Minutes ArmeoSpring (2:1); 30 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants.	Device: Hocoma ArmeoSpring; A spring-loaded upper extremity exoskeleton with 3 joints and 6 degrees of freedom. Participants use the more affected upper extremity to control and engage in therapeutic games.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Upper Extremity Fugl Meyer Assessment	Impairment measure of gross and fine motor upper extremity movements	Baseline, immediately after intervention, 3 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Survey/Enjoyment Scale	Self-report of experience with device and supervision; 20 question scale with 0= no satisfaction/enjoyment, 100= extremely satisfied	Baseline, immediately after intervention, 3 month follow up
Box and Blocks Test	Timed measure of gross manual dexterity	Baseline, immediately after intervention, 3 month follow up
Grip Strength	Measure of force generated by exerting maximal grip	Baseline, immediately after intervention, 3 month follow up
Short Form Health Survey- 36	Self-report questionnaire of health status; minimum score of 0= severe disability and 100 = no disability.	Baseline, immediately after intervention, 3 month follow up
Stroke Impact Scale	Quality of life measure; Consists of 59 items and assesses 8 domains; Minimum score 0= no recovery, Maximum score 100= full recovery	Baseline, immediately after intervention, 3 month follow up

Collaborators and Investigators

• Sponsor: Burke Medical Research Institute
• Collaborators: Hocoma
• Investigators: Principal Investigator: Tomoko Kitago, MD, Burke Medical Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 2, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia; Paresis
• Other Study ID Numbers: BRC540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make individual participant data available to other researchers at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No