Cerebrovascular AccidentNCT01050231
Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training
A study testing Functional/ Multi-joints activities and Individual Joint Training in people with Cerebrovascular Accident, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to develop an upper extremity robotic training system for use by people with stroke to practice arm and hand movement in the clinic. Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Functional/ Multi-joints activities and Individual Joint Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jan 2012
- 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 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 73
- Sustained single stroke at least three months previously
- Minimal to moderate lost motor control of the arm after stroke
Who cannot join
- Concurrent severe medical problems
- Severe cognitive dysfunction
- Severe neglect or apraxia
- Severe visual deficits
- Significant subluxation of the shoulder
- Presence of severe elbow or wrist contracture
Show all 13Show fewer
- Any metal implants or surgical clips or mechanical devices
- Metallic hardware on scalp region
- prior diagnosis of seizure and epilepsy
- severe migraine headache
- currently pregnant or lactating
- claustrophobic
- currently taking medication that lower seizure threshold
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
The purpose of this study is to develop an upper extremity robotic training system for use by people with stroke to practice arm and hand movement in the clinic.
Read the detailed description
Each year in the U.S. over 400,000 people survive a stroke and approximately 80% of acute stroke survivors lose arm and hand movement skills. Movement impairments are typically treated with intensive, hands-on physical and occupational therapy for several weeks after the initial brain injury. Unfortunately, due to economic pressure on the U.S. health care system, stroke patients are receiving less therapy and going home sooner. Our goal for this study is to develop an upper extremity robotic training system for both acute and chronic stroke population to improve movement ability with intensive and repetitive movement in the clinic without continuous supervision from a therapist.
- Conditions
- Cerebrovascular Accident
- Being tested
- Functional/ Multi-joints activities, Individual Joint Training
- Keywords
- stroke, cerebrovascular accident, robot
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional/ Multi-joints activitiesDevice
Subjects participated in 4 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder), 3 days per week, 1 hour per day with the robotic exercise program focusing on functional tasks such as cleaning the windows, driving a steering wheel, grocery shopping, etc.
Individual Joint TrainingDevice
Subjects participated in 4 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements focusing on one joint at a time.
| Study group | Role | What they receive |
|---|---|---|
| Robotic group (Type I) | Experimental | Type I Robotic Therapy (Functional activities first) Participants in this group will participate in functional/task-oriented multi-joint training with the BONES robot first, followed by individual joint training with the BONES robot. A one-week break was provided between interventions. Receives: Device: Functional/ Multi-joints activities; Device: Individual Joint Training |
| Robotic group (Type II) | Active comparator | Type II Robotic Therapy (Individual joints first) Participants in this group will participate in individual joint training with the BONES robot first, followed by functional/task-oriented multi-joint training with the BONES robot. A one-week break was provided between interventions. Receives: Device: Functional/ Multi-joints activities; Device: Individual Joint Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box & Blocks Test
We measured the Box and Blocks Test scores at baseline evaluation, after each intervention, and at the 3-month follow up evaluation. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.
Measured: Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startOct 2006
- Primary completionJan 2012
- Study completionJan 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Reinkensmeyer, University of California, Irvine
- Investigators
- David J Reinkensmeyer, Ph.D, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050231
- Sponsor's protocol ID
- HS#2005-4506
- Status last verified
- Mar 2021
- First submitted
- 21 Feb 2008
- Last updated
- 19 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Milot MH, Spencer SJ, Chan V, Allington JP, Klein J, Chou C, Bobrow JE, Cramer SC, Reinkensmeyer DJ. A crossover pilot study evaluating the functional outcomes of two different types of robotic movement training in chronic stroke survivors using the arm exoskeleton BONES. J Neuroeng Rehabil. 2013 Dec 19;10:112. doi: 10.1186/1743-0003-10-112.
PubMed 24354476
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training
- ClinicalTrials.gov ID
- NCT01050231
- Acronym / sponsor ID
- HS#2005-4506
- Conditions
- Cerebrovascular Accident
- Keywords
- stroke, cerebrovascular accident, robot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Posted 18 Mar 2021
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 develop an upper extremity robotic training system for use by people with stroke to practice arm and hand movement in the clinic.
Detailed description
Each year in the U.S. over 400,000 people survive a stroke and approximately 80% of acute stroke survivors lose arm and hand movement skills. Movement impairments are typically treated with intensive, hands-on physical and occupational therapy for several weeks after the initial brain injury. Unfortunately, due to economic pressure on the U.S. health care system, stroke patients are receiving less therapy and going home sooner. Our goal for this study is to develop an upper extremity robotic training system for both acute and chronic stroke population to improve movement ability with intensive and repetitive movement in the clinic without continuous supervision from a therapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic group (Type I) | Experimental | Device: Functional/ Multi-joints activities, Device: Individual Joint TrainingType I Robotic Therapy (Functional activities first) Participants in this group will participate in functional/task-oriented multi-joint training with the BONES robot first, followed by individual joint training with the BONES robot. A one-week break was provided between interventions. |
| Robotic group (Type II) | Active comparator | Device: Functional/ Multi-joints activities, Device: Individual Joint TrainingType II Robotic Therapy (Individual joints first) Participants in this group will participate in individual joint training with the BONES robot first, followed by functional/task-oriented multi-joint training with the BONES robot. A one-week break was provided between interventions. |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 73
- Sustained single stroke at least three months previously
- Minimal to moderate lost motor control of the arm after stroke
Key exclusion criteria (13 listed)
- Concurrent severe medical problems
- Severe cognitive dysfunction
- Severe neglect or apraxia
- Severe visual deficits
- Significant subluxation of the shoulder
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 |
|---|---|---|
| Functional/ Multi-joints activitiesSubjects participated in 4 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder), 3 days per week, 1 hour per day with the robotic exercise program focusing on functional tasks such as cleaning the windows, driving a steering wheel, grocery shopping, etc. | Device | Robotic group (Type I), Robotic group (Type II) |
| Individual Joint TrainingSubjects participated in 4 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements focusing on one joint at a time. | Device | Robotic group (Type I), Robotic group (Type II) |
Primary outcome
Box & Blocks Test
Time frame: Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention.
We measured the Box and Blocks Test scores at baseline evaluation, after each intervention, and at the 3-month follow up evaluation. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24354476Milot MH, Spencer SJ, Chan V, Allington JP, Klein J, Chou C, Bobrow JE, Cramer SC, Reinkensmeyer DJ. A crossover pilot study evaluating the functional outcomes of two different types of robotic movement training in chronic stroke survivors using the arm exoskeleton BONES. J Neuroeng Rehabil. 2013 Dec 19;10:112. doi: 10.1186/1743-0003-10-112.
- 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.
David J Reinkensmeyer, Ph.D principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional/ Multi-joints activities and Individual Joint Training in people with Cerebrovascular Accident, run by University of California, Irvine 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 3 inclusion and 13 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 19 Apr 2021. 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 18 Mar 2021). 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?
Box & Blocks Test (time frame: Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second 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 NCT01050231, 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 19 Apr 2021.