HemiparesisPhase 3NCT03555825
Burke-Hocoma Efficiency Study
A Phase 3 study testing Hocoma ArmeoSpring in people with Hemiparesis and Hemiplegia, run by Burke Medical Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiparesis, Hemiplegia
- What is being tested?
- Hocoma ArmeoSpring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Medical Research Institute
White Plains, New York, 10605
About this 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.
Read the 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.
- Conditions
- Hemiparesis, Hemiplegia
- Being tested
- Hocoma ArmeoSpring
- Medical subject headings
- Paresis, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hocoma ArmeoSpringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Hocoma ArmeoSpring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Extremity Fugl Meyer Assessment
Impairment measure of gross and fine motor upper extremity movements
Measured: Baseline, immediately after intervention, 3 month follow up
Secondary outcomes (5)
Patient Satisfaction Survey/Enjoyment Scale
Self-report of experience with device and supervision; 20 question scale with 0= no satisfaction/enjoyment, 100= extremely satisfied
Measured: Baseline, immediately after intervention, 3 month follow up
Box and Blocks Test
Timed measure of gross manual dexterity
Measured: Baseline, immediately after intervention, 3 month follow up
Grip Strength
Measure of force generated by exerting maximal grip
Measured: Baseline, immediately after intervention, 3 month follow up
Short Form Health Survey- 36
Self-report questionnaire of health status; minimum score of 0= severe disability and 100 = no disability.
Measured: Baseline, immediately after intervention, 3 month follow up
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
Measured: Baseline, immediately after intervention, 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 May 2016
- Primary completion1 Jul 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burke Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hocoma
- Responsible party
- Sponsor
- Investigators
- Tomoko Kitago, MD, Principal investigator, Burke Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555825
- Sponsor's protocol ID
- BRC540
- Status last verified
- Oct 2022
- First submitted
- 15 May 2018
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers at this time.
Publications
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.
PubMed 32250331
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burke-Hocoma Efficiency Study
- ClinicalTrials.gov ID
- NCT03555825
- Acronym / sponsor ID
- BRC540
- Conditions
- Hemiparesis, Hemiplegia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Burke Medical Research InstituteUniversity, hospital or other
- Collaborators
- Hocoma
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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)
| Arm | Type | Receives |
|---|---|---|
| 60 Minutes ArmeoSpring (1:1) | Active comparator | Device: Hocoma ArmeoSpring60 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session. |
| 60 Minutes ArmeoSpring (2:1) | Experimental | Device: Hocoma ArmeoSpring60 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants. |
| 30 Minutes ArmeoSpring (1:1) | Active comparator | Device: Hocoma ArmeoSpring30 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session. |
| 30 Minutes ArmeoSpring (2:1) | Experimental | Device: Hocoma ArmeoSpring30 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hocoma ArmeoSpringA 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. | Device | 30 Minutes ArmeoSpring (1:1), 30 Minutes ArmeoSpring (2:1), 60 Minutes ArmeoSpring (1:1), 60 Minutes ArmeoSpring (2:1) |
Primary outcome
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
5 secondary outcomes
Patient Satisfaction Survey/Enjoyment Scale
Time frame: Baseline, immediately after intervention, 3 month follow up
Box and Blocks Test
Time frame: Baseline, immediately after intervention, 3 month follow up
Grip Strength
Time frame: Baseline, immediately after intervention, 3 month follow up
Short Form Health Survey- 36
Time frame: Baseline, immediately after intervention, 3 month follow up
Stroke Impact Scale
Time frame: Baseline, immediately after intervention, 3 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Results publication: PubMed 32250331Wuennemann 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers at this time.
Related trials for Hemiparesis
Not yet recruiting
Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke
Hemiparesis, Ischemic Stroke
Active, not recruiting
Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
Stroke, Hemiparesis
Recruiting
Telerehabilitation for Post-Stroke Hand Function
Stroke
RecruitingObservational study
Kinematic Analysis of Manual Dexterity
Down Syndrome, Hemiparesis
Not yet recruiting
Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Hemiplegia, Hemiparesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomoko Kitago, MD principal investigator
Burke Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hocoma ArmeoSpring in people with Hemiparesis and Hemiplegia, run by Burke Medical Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Extremity Fugl Meyer Assessment (time frame: Baseline, immediately after intervention, 3 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03555825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.