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Burke-Hocoma Efficiency Study

Sponsor
Burke Medical Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT03555825
Collaborator
Hocoma (Other)
20
Enrollment
1
Location
4
Arms
43
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hocoma ArmeoSpring
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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)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)
Primary Purpose:
Other
Official Title:
Burke-Hocoma Efficiency Study
Actual Study Start Date :
May 1, 2016
Anticipated Primary Completion Date :
Jul 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Upper Extremity Fugl Meyer Assessment [Baseline, immediately after intervention, 3 month follow up]

    Impairment measure of gross and fine motor upper extremity movements

Secondary Outcome Measures

  1. Patient Satisfaction Survey/Enjoyment Scale [Baseline, immediately after intervention, 3 month follow up]

    Self-report of experience with device and supervision; 20 question scale with 0= no satisfaction/enjoyment, 100= extremely satisfied

  2. Box and Blocks Test [Baseline, immediately after intervention, 3 month follow up]

    Timed measure of gross manual dexterity

  3. Grip Strength [Baseline, immediately after intervention, 3 month follow up]

    Measure of force generated by exerting maximal grip

  4. Short Form Health Survey- 36 [Baseline, immediately after intervention, 3 month follow up]

    Self-report questionnaire of health status; minimum score of 0= severe disability and 100 = no disability.

  5. Stroke Impact Scale [Baseline, immediately after intervention, 3 month follow up]

    Quality of life measure; Consists of 59 items and assesses 8 domains; Minimum score 0= no recovery, Maximum score 100= full recovery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Burke Medical Research Institute White Plains New York United States 10605

Sponsors and Collaborators

  • Burke Medical Research Institute
  • Hocoma

Investigators

  • Principal Investigator: Tomoko Kitago, MD, Burke Medical Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Burke Medical Research Institute
ClinicalTrials.gov Identifier:
NCT03555825
Other Study ID Numbers:
  • BRC540
First Posted:
Jun 14, 2018
Last Update Posted:
Jul 9, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Hemiplegia
Paresis

Study Results

No Results Posted as of Jul 9, 2019