StrokeNCT01726660
The General Use of Robots in Stroke Recovery
A study testing IMT Robotic Arm therapy in people with Stroke, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to determine if tailoring multiple sessions of upper extremity robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming; active range of motion vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- IMT Robotic Arm therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2015
- Phase
- Interventional
- 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
- 18 years of age or older
- First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
- Cognitive function sufficient enough to understand experiments and follow instructions
- Fugl Meyer assessment at admission of 7 to 38 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
Who cannot join
- Prior experience with robotic arm therapy
- Fixed contraction of the affected limb
- Complete flaccid paralysis of the affected limb
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
Official title: Pilot Study of the Effects of Protocol-Specific Robotic Arm Therapy in Stroke Recovery
The purpose of this study is to determine if tailoring multiple sessions of upper extremity robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming; active range of motion vs. functional practice)can optimize therapeutic results and lead to greater functional returns in arm mobility after stroke.
- Conditions
- Stroke
- Being tested
- IMT Robotic Arm therapy
- Keywords
- Stroke, Cerebrovascular Accident, Cerebral stroke, CVA, robotic therapy, upper extremity recovery, kinematic training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMT Robotic Arm therapyDevice
Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy
| Study group | Role | What they receive |
|---|---|---|
| IMT Robotic Arm Therapy: Aim training | Experimental | Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks. Receives: Device: IMT Robotic Arm therapy |
| IMT Robotic Arm Therapy: Smoothness Training | Experimental | Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks. Receives: Device: IMT Robotic Arm therapy |
| IMT Robotic Arm Therapy: Impairment training | Experimental | Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks. Receives: Device: IMT Robotic Arm therapy |
| IMT Robotic Arm Therapy: Functional training | Experimental | Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks. Receives: Device: IMT Robotic Arm therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Upper Extremity Fugl Meyer Motor Assessment
Measured: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Secondary outcomes (3)
Change from baseline in Kinematic Data
Kinematic Data recorded during therapy with IMT robots
Measured: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Change from baseline in Fugl Meyer Sensation Scale
Measured: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Change from baseline in Fugl Meyer Proprioception Scale
Measured: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2015
- Study completionDec 2015
Why it stopped: Unfunded
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 StrokeStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Volpe, Northwell Health
- Investigators
- Bruce T Volpe, MD, Principal investigator, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726660
- Sponsor's protocol ID
- 11-121B
- Status last verified
- Feb 2018
- First submitted
- 26 Oct 2012
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Stein J, Krebs HI, Frontera WR, Fasoli SE, Hughes R, Hogan N. Comparison of two techniques of robot-aided upper limb exercise training after stroke. Am J Phys Med Rehabil. 2004 Sep;83(9):720-8. doi: 10.1097/01.phm.0000137313.14480.ce.
PubMed 15314537
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effects of Protocol-Specific Robotic Arm Therapy in Stroke Recovery
- ClinicalTrials.gov ID
- NCT01726660
- Acronym / sponsor ID
- 11-121B
- Conditions
- Stroke
- Keywords
- Stroke, Cerebrovascular Accident, Cerebral stroke, CVA, robotic therapy, upper extremity recovery, kinematic training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unfunded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Nov 2012 (estimated)
- 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 purpose of this study is to determine if tailoring multiple sessions of upper extremity robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming; active range of motion vs. functional practice)can optimize therapeutic results and lead to greater functional returns in arm mobility after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IMT Robotic Arm Therapy: Aim training | Experimental | Device: IMT Robotic Arm therapyAlternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks. |
| IMT Robotic Arm Therapy: Smoothness Training | Experimental | Device: IMT Robotic Arm therapyAlternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks. |
| IMT Robotic Arm Therapy: Impairment training | Experimental | Device: IMT Robotic Arm therapyAlternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks. |
| IMT Robotic Arm Therapy: Functional training | Experimental | Device: IMT Robotic Arm therapyAlternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
- Cognitive function sufficient enough to understand experiments and follow instructions
- Fugl Meyer assessment at admission of 7 to 38 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
Key exclusion criteria (3 listed)
- Prior experience with robotic arm therapy
- Fixed contraction of the affected limb
- Complete flaccid paralysis of the affected limb
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 |
|---|---|---|
| IMT Robotic Arm therapyInteractive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy | Device | IMT Robotic Arm Therapy: Aim training, IMT Robotic Arm Therapy: Functional training, IMT Robotic Arm Therapy: Impairment training, IMT Robotic Arm Therapy: Smoothness Training |
Primary outcome
Change from baseline in Upper Extremity Fugl Meyer Motor Assessment
Time frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
3 secondary outcomes
Change from baseline in Kinematic Data
Time frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Change from baseline in Fugl Meyer Sensation Scale
Time frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Change from baseline in Fugl Meyer Proprioception Scale
Time frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Background: PubMed 15314537Stein J, Krebs HI, Frontera WR, Fasoli SE, Hughes R, Hogan N. Comparison of two techniques of robot-aided upper limb exercise training after stroke. Am J Phys Med Rehabil. 2004 Sep;83(9):720-8. doi: 10.1097/01.phm.0000137313.14480.ce.
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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.
Bruce T Volpe, MD principal investigator
Feinstein Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMT Robotic Arm therapy in people with Stroke, run by Northwell Health 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: withdrawn, as of the sponsor's last update on 5 Feb 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 from baseline in Upper Extremity Fugl Meyer Motor Assessment (time frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)). 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 NCT01726660, 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 5 Feb 2018.