Acute StrokePhase 1NCT00785343
Study of Robot-assisted Arm Therapy for Acute Stroke Patients
A Phase 1 study testing Reo Go robotic arm trainer and Conventional Therapy in people with Acute Stroke and Paresis, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this study is to compare standard occupational therapy to a combination of conventional (standard) and robotic therapy. The Reo Go device will provide robotic therapy that gives therapists a tool that could make stroke treatment faster and better by helping patients practice more accurate arm movements… Read more about this study
- Who is it for?
- Ages 65 to 84 years
- Conditions the study is for
- Acute Stroke, Paresis
- What is being tested?
- Reo Go robotic arm trainer and Conventional Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to not given
- Phase
- Phase 1
- 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 65 to 84 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
None listed.
Who cannot join
- Previous stroke history
- Hemorrhagic stroke, cerebellar stroke, or subarachnoid hemorrhage
- Contractures in the involved upper extremity at the shoulder, elbow, or wrist
- Moderate to severe tone in the involved upper extremity
- Flaccid involved upper extremity
- Full, active isolated movement of the involved upper extremity
Show all 9Show fewer
- Corrected visual acuity worse than 20/50 for distance
- Cognitive or other deficits that would negatively affect their ability to follow directions or track visual targets
- Unstable cardiovascular orthopedic or neurological conditions that would preclude exercise in short-duration, high work-load trials
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Institute for Rehabilitation
Saddle Brook, New Jersey, 07663
Lauren McDonagh, 201-368-6081, lmcdonagh@KESSLER-REHAB.com
Lauren McDonagh
About this study
Official title: Effectiveness of Adding Robotic Therapy to Conventional Therapy for Acute Stroke Patients With Upper Extremity Paresis
The purpose of this study is to compare standard occupational therapy to a combination of conventional (standard) and robotic therapy. The Reo Go device will provide robotic therapy that gives therapists a tool that could make stroke treatment faster and better by helping patients practice more accurate arm movements with help from the device.
Read the detailed description
HYPOTHESES
- Motor function will be significantly greater for the patients in the robotic training group as measured by standard clinical evaluations.
- Functional independence gains will be similar for both groups because the robotic therapy is not task-specific for activities of daily living (ADL).
- Robotic training will reduce pain and spasticity more effectively than conventional therapy alone, due to increased number of movements performed during the robotic training.
- Muscle activation patterns for patients receiving robotic training will show decreased agonist/antagonist co-contraction and less erratic muscle activation.
- Robotic training patients will demonstrate significantly greater ROM, movement accuracy and higher movement speed during exercises performed as part of robotic training. For robotic exercises performed only as part of the robotic assessment, these improvements will be significantly less than those for practiced movements.
- Conditions
- Acute Stroke, Paresis
- Being tested
- Reo Go robotic arm trainer, Conventional Therapy
- Keywords
- stroke, acute, arm, robot, therapy, arm paresis
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reo Go robotic arm trainerDevice
Robotic training with the Reo Go is included with conventional treatment during daily OT sessions
Conventional TherapyProcedure or surgery
Occupational therapy that is the current standard of care
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment | Active comparator | Not described Receives: Procedure: Conventional Therapy |
| Robotic and Conventional Therapy | Experimental | Not described Receives: Device: Reo Go robotic arm trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Score
Measured: Start and end of treatment
Secondary outcomes (1)
EMG - muscle activation and co-contraction index
Measured: Start and end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Kessler Institute for Rehabilitation
- Investigators
- Lauren McDonagh, PT, Principal investigator, Kessler Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785343
- Sponsor's protocol ID
- R-618-08
- Status last verified
- Dec 2009
- First submitted
- 4 Nov 2008
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lum PS, Burgar CG, Shor PC. Evidence for strength imbalances as a significant contributor to abnormal synergies in hemiparetic subjects. Muscle Nerve. 2003 Feb;27(2):211-21. doi: 10.1002/mus.10305.
PubMed 12548529Prange GB, Jannink MJ, Groothuis-Oudshoorn CG, Hermens HJ, Ijzerman MJ. Systematic review of the effect of robot-aided therapy on recovery of the hemiparetic arm after stroke. J Rehabil Res Dev. 2006 Mar-Apr;43(2):171-84. doi: 10.1682/jrrd.2005.04.0076.
PubMed 16847784
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adding Robotic Therapy to Conventional Therapy for Acute Stroke Patients With Upper Extremity Paresis
- ClinicalTrials.gov ID
- NCT00785343
- Acronym / sponsor ID
- R-618-08
- Conditions
- Acute Stroke, Paresis
- Keywords
- stroke, acute, arm, robot, therapy, arm paresis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Kessler Institute for Rehabilitation
- Study start
- Sep 2008
- First posted
- 5 Nov 2008 (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 compare standard occupational therapy to a combination of conventional (standard) and robotic therapy. The Reo Go device will provide robotic therapy that gives therapists a tool that could make stroke treatment faster and better by helping patients practice more accurate arm movements with help from the device.
Detailed description
HYPOTHESES
- Motor function will be significantly greater for the patients in the robotic training group as measured by standard clinical evaluations.
- Functional independence gains will be similar for both groups because the robotic therapy is not task-specific for activities of daily living (ADL).
- Robotic training will reduce pain and spasticity more effectively than conventional therapy alone, due to increased number of movements performed during the robotic training.
- Muscle activation patterns for patients receiving robotic training will show decreased agonist/antagonist co-contraction and less erratic muscle activation.
- Robotic training patients will demonstrate significantly greater ROM, movement accuracy and higher movement speed during exercises performed as part of robotic training. For robotic exercises performed only as part of the robotic assessment, these improvements will be significantly less than those for practiced movements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment | Active comparator | Procedure: Conventional Therapy |
| Robotic and Conventional Therapy | Experimental | Device: Reo Go robotic arm trainer |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Previous stroke history
- Hemorrhagic stroke, cerebellar stroke, or subarachnoid hemorrhage
- Contractures in the involved upper extremity at the shoulder, elbow, or wrist
- Moderate to severe tone in the involved upper extremity
- Flaccid involved upper extremity
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 |
|---|---|---|
| Reo Go robotic arm trainerRobotic training with the Reo Go is included with conventional treatment during daily OT sessions | Device | Robotic and Conventional Therapy |
| Conventional TherapyOccupational therapy that is the current standard of care | Procedure or surgery | Conventional Treatment |
Primary outcome
Fugl-Meyer Score
Time frame: Start and end of treatment
1 secondary outcome
EMG - muscle activation and co-contraction index
Time frame: Start and end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
- Background: PubMed 12548529Lum PS, Burgar CG, Shor PC. Evidence for strength imbalances as a significant contributor to abnormal synergies in hemiparetic subjects. Muscle Nerve. 2003 Feb;27(2):211-21. doi: 10.1002/mus.10305.
- Background: PubMed 16847784Prange GB, Jannink MJ, Groothuis-Oudshoorn CG, Hermens HJ, Ijzerman MJ. Systematic review of the effect of robot-aided therapy on recovery of the hemiparetic arm after stroke. J Rehabil Res Dev. 2006 Mar-Apr;43(2):171-84. doi: 10.1682/jrrd.2005.04.0076.
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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.
Lauren McDonagh, PT principal investigator
Kessler Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Reo Go robotic arm trainer and Conventional Therapy in people with Acute Stroke and Paresis, run by Kessler Foundation 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 0 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Dec 2009. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lauren McDonagh, PT (201-368-6081, lmcdonagh@KESSLER-REHAB.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Score (time frame: Start and end of treatment). 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 NCT00785343, which also lists 2 linked publications.
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 24 Dec 2009.