StrokeNCT01485354
Upper Arm Training With Armeo Spring for Stroke
A study testing Armeo Spring training in people with Stroke, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
The purpose of this study is to assess the clinical outcomes of upper extremity training using the Armeo Spring system in a chronic post-stroke population with impaired upper extremity function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Armeo Spring training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female, community dwelling, age 18-70
- First-time non-traumatic ischemic or hemorrhagic stroke at least 3 months prior to study enrollment
- Score of 15-55 out of 66 on arm motor Fugl-Meyer scale
- The ability to extend >=10 degrees at metacarpophalangeal and interphalangeal joint of all digits
Who cannot join
- Cognitive impairment that may interfere with understanding instructions for motor tasks and assessment tools
- Inability to operate the Armeo system (subjects must have sufficient range of movement to enable calibration of the virtual workspace)
- Participation in other forms of therapy/intervention for upper extremity motor recovery
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, 02129
About this study
Official title: The Effect of Repetitive Upper Arm Training in a Virtual Environment on Upper Extremity Motor Recovery in Chronic-stroke Survivors
The purpose of this study is to assess the clinical outcomes of upper extremity training using the Armeo Spring system in a chronic post-stroke population with impaired upper extremity function.
Read the detailed description
The Armeo Spring system is an adjustable arm orthosis that has received FDA 510K clearance. It passively counterbalances the weight of the arm, thereby reducing the effort required to overcome gravity during the performance of upper-limb movements. The device provides subjects with augmented feedback via a virtual environment (i.e. computer games). The tasks to be performed in the virtual environment are designed to achieve functional movements, such as arm reaching movements.
The goal of the study is to assess the clinical outcomes of upper extremity training using the Armeo Spring system in a chronic post-stroke population with impaired upper extremity function. The Armeo Spring system is equipped with a grip sensor that subjects squeeze with their hand to interact with virtual objects during the games. In a first phase of the study, we attempted to replace the grip sensor that is part of the system with a sensorized glove, to facilitate a more natural movement of hand opening/closing. However, we experienced technical difficulties with the sensorized glove and decided to abandon this aim for the purpose of gathering data about the clinical outcomes of upper extremity training using the Armeo Spring system.
- Conditions
- Stroke
- Being tested
- Armeo Spring training
- Keywords
- Stroke, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armeo Spring trainingDevice
Also called Armeo Spring (Hocoma AG, Switzerland)
Upper-limb training using the Armeo system for a period of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Armeo Spring training | Experimental | Subjects will participate in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention will consist of 18 training sessions (60 minute sessions, 3 times a week). Receives: Device: Armeo Spring training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper-extremity Fugl-Meyer Score (Measure of Motor Impairment) (i.e. Difference Between Fugl-Meyer Score at Baseline and at Completion of the 3-week Intervention)
The upper-extremity Fugl-Meyer scale allow one to assess the severity of motor impairments in stroke survivors using a scale from 0 (severe impairment) to 66 (no impairment). It is based on visual observations gathered by asking subjects to perform upper-limb movements using the stroke-affected limb. Therapists rate the performance of the motor tasks using an ordinal scale ranging from 0 (cannot perform) to 2 (can perform fully) that captures the motor ability of the individual. The investigators computed the difference between the Fugl-Meyer score at completion of the 3-week intervention and the Fugl-Meyer score at baseline.
Measured: Data collected at baseline and at completion of the 3-week intervention
Secondary outcomes (4)
Change in Wolf Motor Function Test Score (a Functional Test) (i.e. Difference Between Wolf Motor Function Test Score at Baseline and at Completion of the 3-week Intervention)
The Wolf Motor Function test is designed to assess the severity of functional limitations in stroke survivors. The scale is administered by asking subjects to perform a series of functional movements (e.g. reach for and pick up a paperclip). The outcome of the assessment is the average time needed to perform the motor tasks that are part of the assessment. The score ranges from 0 to 120 s (i.e. if the subject is unable to perform the task, the score for that task is set to 120 s). The investigators computed the difference between the Wolf Motor Function Test score at completion of the 3-week intervention and the Wolf Motor Function Test score at baseline.
Measured: Data collected at baseline and at completion of the 3-week intervention
Change in Functional Ability Scale Score (Scale to Rate Quality of Movement) (i.e. Difference Between Functional Ability Scale Score at Baseline and at Completion of the 3-week Intervention)
The Functional Ability Scale is designed to assess the quality of movement during the performance of a battery of functional tasks. Therapists observe the subject while performing the motor tasks and use an ordinal scale to rate the quality of movement. The scale used to rate each motor task ranges from 0 to 5. The Functional Ability Scale is derived by adding up the scores for each motor task performed by the subject. Subjects perform 15 motor tasks. Hence the Functional Ability Scale score varies from 0 (very poor quality of movement) to 75 (physiological movement). The investigators computed the difference between the Functional Ability Scale score at completion of the 3-week intervention and the Functional Ability Scale score at baseline.
Measured: Data collected at baseline and at completion of the 3-week intervention
Change in Box and Block Test Score (Manual Dexterity Test) (i.e. Difference Between Box and Block Test Score at Baseline and at Completion of the 3-week Intervention)
The Box and Block test is designed to assess manual dexterity in subjects with motor impairments. Subjects are asked to move small wooden blocks from one box to another, moving their stroke-affected arm over a divider between the two boxes. The output of the test is the number of blocks that the subject moves from one box to the other within a set amount of time (i.e. 1 min). Older adults who are otherwise healthy would typically move 60 to 70 blocks in 1 min. Hence, the range of the scale for older adults is 0 to 70. The investigators computed the difference between the Box and Block Test score at completion of the 3-week intervention and the Box and Block Test score at baseline.
Measured: Data collected at baseline and at completion of the 3-week intervention
Change in Grip Strength (Strength Test) (i.e. Difference Between Grip Strength at Baseline and at Completion of the 3-week Intervention)
This test is carried out by using a hand dynamometer that measures the grip strength of the individual in kilograms (used as a measure of force). Subjects are instructed to position the thumb on one handle of the dynamometer and the other fingers on the other handle of the dynamometer. The device measures the force generated by the subject using a power grip. The investigators computed the difference between the Grip Strength value at completion of the 3-week intervention and the Grip Strength value at baseline.
Measured: Data collected at baseline and at completion of the 3-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startDec 2008
- Primary completionOct 2015
- Study completionMar 2017
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485354
- Sponsor's protocol ID
- 2008-P-001255
- Status last verified
- Jun 2017
- First submitted
- 28 Jun 2011
- Last updated
- 12 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Repetitive Upper Arm Training in a Virtual Environment on Upper Extremity Motor Recovery in Chronic-stroke Survivors
- ClinicalTrials.gov ID
- NCT01485354
- Acronym / sponsor ID
- 2008-P-001255
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Dec 2008 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Posted 12 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the clinical outcomes of upper extremity training using the Armeo Spring system in a chronic post-stroke population with impaired upper extremity function.
Detailed description
The Armeo Spring system is an adjustable arm orthosis that has received FDA 510K clearance. It passively counterbalances the weight of the arm, thereby reducing the effort required to overcome gravity during the performance of upper-limb movements. The device provides subjects with augmented feedback via a virtual environment (i.e. computer games). The tasks to be performed in the virtual environment are designed to achieve functional movements, such as arm reaching movements.
The goal of the study is to assess the clinical outcomes of upper extremity training using the Armeo Spring system in a chronic post-stroke population with impaired upper extremity function. The Armeo Spring system is equipped with a grip sensor that subjects squeeze with their hand to interact with virtual objects during the games. In a first phase of the study, we attempted to replace the grip sensor that is part of the system with a sensorized glove, to facilitate a more natural movement of hand opening/closing. However, we experienced technical difficulties with the sensorized glove and decided to abandon this aim for the purpose of gathering data about the clinical outcomes of upper extremity training using the Armeo Spring system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Armeo Spring training | Experimental | Device: Armeo Spring trainingSubjects will participate in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention will consist of 18 training sessions (60 minute sessions, 3 times a week). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female, community dwelling, age 18-70
- First-time non-traumatic ischemic or hemorrhagic stroke at least 3 months prior to study enrollment
- Score of 15-55 out of 66 on arm motor Fugl-Meyer scale
- The ability to extend >=10 degrees at metacarpophalangeal and interphalangeal joint of all digits
Key exclusion criteria (3 listed)
- Cognitive impairment that may interfere with understanding instructions for motor tasks and assessment tools
- Inability to operate the Armeo system (subjects must have sufficient range of movement to enable calibration of the virtual workspace)
- Participation in other forms of therapy/intervention for upper extremity motor recovery
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 |
|---|---|---|
| Armeo Spring trainingAlso: Armeo Spring (Hocoma AG, Switzerland)Upper-limb training using the Armeo system for a period of 6 weeks | Device | Armeo Spring training |
Primary outcome
Change in Upper-extremity Fugl-Meyer Score (Measure of Motor Impairment) (i.e. Difference Between Fugl-Meyer Score at Baseline and at Completion of the 3-week Intervention)
Time frame: Data collected at baseline and at completion of the 3-week intervention
The upper-extremity Fugl-Meyer scale allow one to assess the severity of motor impairments in stroke survivors using a scale from 0 (severe impairment) to 66 (no impairment). It is based on visual observations gathered by asking subjects to perform upper-limb movements using the stroke-affected limb. Therapists rate the performance of the motor tasks using an ordinal scale ranging from 0 (cannot perform) to 2 (can perform fully) that captures the motor ability of the individual. The investigators computed the difference between the Fugl-Meyer score at completion of the 3-week intervention and the Fugl-Meyer score at baseline.
4 secondary outcomes
Change in Wolf Motor Function Test Score (a Functional Test) (i.e. Difference Between Wolf Motor Function Test Score at Baseline and at Completion of the 3-week Intervention)
Time frame: Data collected at baseline and at completion of the 3-week intervention
Change in Functional Ability Scale Score (Scale to Rate Quality of Movement) (i.e. Difference Between Functional Ability Scale Score at Baseline and at Completion of the 3-week Intervention)
Time frame: Data collected at baseline and at completion of the 3-week intervention
Change in Box and Block Test Score (Manual Dexterity Test) (i.e. Difference Between Box and Block Test Score at Baseline and at Completion of the 3-week Intervention)
Time frame: Data collected at baseline and at completion of the 3-week intervention
Change in Grip Strength (Strength Test) (i.e. Difference Between Grip Strength at Baseline and at Completion of the 3-week Intervention)
Time frame: Data collected at baseline and at completion of the 3-week intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Paolo Bonato, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Armeo Spring training in people with Stroke, run by Spaulding Rehabilitation Hospital 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 12 Jul 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Score (Measure of Motor Impairment) (i.e. Difference Between Fugl-Meyer Score at Baseline and at Completion of the 3-week Intervention) (time frame: Data collected at baseline and at completion of the 3-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2017.