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Completed

NCT Number: NCT03555825

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Burke Medical Research Institute

White Plains, New York, 10605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hocoma ArmeoSpring

Device

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 outcomes

  1. Change in Upper Extremity Fugl Meyer Assessment

    Time frame: Baseline, immediately after intervention, 3 month follow up

    Impairment measure of gross and fine motor upper extremity movements

Secondary outcomes

  1. Patient Satisfaction Survey/Enjoyment Scale

    Time frame: 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

    Time frame: Baseline, immediately after intervention, 3 month follow up

    Timed measure of gross manual dexterity

  3. Grip Strength

    Time frame: Baseline, immediately after intervention, 3 month follow up

    Measure of force generated by exerting maximal grip

  4. Short Form Health Survey- 36

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Burke Medical Research Institute

Other

Collaborators

  • Hocoma

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jun 14, 2018
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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