Burke-Hocoma Efficiency Study

Hemiplegia Clinical Trial

Official title:

Burke-Hocoma Efficiency Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555825
• Other study ID #: BRC540
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2016
• Est. completion date: December 2020

Study information

• Verified date: October 2022
• Source: Burke Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Hemiplegia
• Paresis

Intervention

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.

Locations

Country	Name	City	State
United States	Burke Medical Research Institute	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Burke Medical Research Institute	Hocoma

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Box and Blocks Test	Timed measure of gross manual dexterity	Baseline, immediately after intervention, 3 month follow up
Secondary	Grip Strength	Measure of force generated by exerting maximal grip	Baseline, immediately after intervention, 3 month follow up
Secondary	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
Secondary	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