Burke-Hocoma Efficiency Study

NCT03555825 | Completed Phase 3 FDA Device

• 1 other identifier: BRC540
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparesis; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient Satisfaction Survey/Enjoyment Scale

  Baseline, immediately after intervention, 3 month follow up

• Box and Blocks Test

  Baseline, immediately after intervention, 3 month follow up

• Grip Strength

  Baseline, immediately after intervention, 3 month follow up

• Short Form Health Survey- 36

  Baseline, immediately after intervention, 3 month follow up

• Stroke Impact Scale

  Baseline, immediately after intervention, 3 month follow up

Study Arms (4)

60 Minutes ArmeoSpring (1:1)

ACTIVE COMPARATOR

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

Device: Hocoma ArmeoSpring

60 Minutes ArmeoSpring (2:1)

EXPERIMENTAL

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

Device: Hocoma ArmeoSpring

30 Minutes ArmeoSpring (1:1)

ACTIVE COMPARATOR

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

Device: Hocoma ArmeoSpring

30 Minutes ArmeoSpring (2:1)

EXPERIMENTAL

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

Device: Hocoma ArmeoSpring

Interventions

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.

30 Minutes ArmeoSpring (1:1); 30 Minutes ArmeoSpring (2:1); 60 Minutes ArmeoSpring (1:1); 60 Minutes ArmeoSpring (2:1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Burke Medical Research Institute: lead
• Hocoma: collaborator

Study Sites (1)

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

Related 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.

  PMID: 32250331 RESULT

MeSH Terms

Conditions

Paresis; Hemiplegia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Study Officials

• Tomoko Kitago, MD

  Burke Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 14, 2018
• Study Start: May 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2020
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)