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Burke-Hocoma Efficiency Study

Primary Purpose

Hemiparesis, Hemiplegia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hocoma ArmeoSpring
Sponsored by
Burke Medical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemiparesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Burke Medical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

60 Minutes ArmeoSpring (1:1)

60 Minutes ArmeoSpring (2:1)

30 Minutes ArmeoSpring (1:1)

30 Minutes ArmeoSpring (2:1)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change in Upper Extremity Fugl Meyer Assessment
Impairment measure of gross and fine motor upper extremity movements

Secondary Outcome Measures

Patient Satisfaction Survey/Enjoyment Scale
Self-report of experience with device and supervision; 20 question scale with 0= no satisfaction/enjoyment, 100= extremely satisfied
Box and Blocks Test
Timed measure of gross manual dexterity
Grip Strength
Measure of force generated by exerting maximal grip
Short Form Health Survey- 36
Self-report questionnaire of health status; minimum score of 0= severe disability and 100 = no disability.
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

Full Information

First Posted
May 15, 2018
Last Updated
October 2, 2022
Sponsor
Burke Medical Research Institute
Collaborators
Hocoma
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1. Study Identification

Unique Protocol Identification Number
NCT03555825
Brief Title
Burke-Hocoma Efficiency Study
Official Title
Burke-Hocoma Efficiency Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Burke Medical Research Institute
Collaborators
Hocoma

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Hemiplegia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
60 Minutes ArmeoSpring (1:1)
Arm Type
Active Comparator
Arm Description
60 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session.
Arm Title
60 Minutes ArmeoSpring (2:1)
Arm Type
Experimental
Arm Description
60 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants.
Arm Title
30 Minutes ArmeoSpring (1:1)
Arm Type
Active Comparator
Arm Description
30 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session.
Arm Title
30 Minutes ArmeoSpring (2:1)
Arm Type
Experimental
Arm Description
30 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants.
Intervention Type
Device
Intervention Name(s)
Hocoma ArmeoSpring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Upper Extremity Fugl Meyer Assessment
Description
Impairment measure of gross and fine motor upper extremity movements
Time Frame
Baseline, immediately after intervention, 3 month follow up
Secondary Outcome Measure Information:
Title
Patient Satisfaction Survey/Enjoyment Scale
Description
Self-report of experience with device and supervision; 20 question scale with 0= no satisfaction/enjoyment, 100= extremely satisfied
Time Frame
Baseline, immediately after intervention, 3 month follow up
Title
Box and Blocks Test
Description
Timed measure of gross manual dexterity
Time Frame
Baseline, immediately after intervention, 3 month follow up
Title
Grip Strength
Description
Measure of force generated by exerting maximal grip
Time Frame
Baseline, immediately after intervention, 3 month follow up
Title
Short Form Health Survey- 36
Description
Self-report questionnaire of health status; minimum score of 0= severe disability and 100 = no disability.
Time Frame
Baseline, immediately after intervention, 3 month follow up
Title
Stroke Impact Scale
Description
Quality of life measure; Consists of 59 items and assesses 8 domains; Minimum score 0= no recovery, Maximum score 100= full recovery
Time Frame
Baseline, immediately after intervention, 3 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomoko Kitago, MD
Organizational Affiliation
Burke Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burke Medical Research Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers at this time.
Citations:
PubMed Identifier
32250331
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.
Results Reference
result

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Burke-Hocoma Efficiency Study

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