StrokeNCT00758147
Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke
A study testing Exercise with force feedback joystick in people with Stroke, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to assess the influence of force feedback joysticks and haptic feedback in improving upper limb rehabilitation outcomes following stroke. Read more about this study
- Who is it for?
- Ages 65 to 86 years
- Conditions the study is for
- Stroke
- What is being tested?
- Exercise with force feedback joystick
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Jun 2010
- 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 65 to 86 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Medically stable post first stroke patients
- Score of more than 17 on the Mini Mental Scale Test(MMST)
Who cannot join
- A history of psychiatric illness
- Inability to understand the informed consent form
- Inability to understand and follow 2-3 step instructions
- Receptive aphasia (sensory aphasia)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Beit Rivka Geriatric Hospital
Petah Tikva, 49245
Shai Brill, M.D., 972-3-9373811, shaybr@clalit.org.il
Riki Brown, MSc, 972-3-9373974, rikib2@clalit.org.il
About this study
Official title: Assessment of Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke
The purpose of this study is to assess the influence of force feedback joysticks and haptic feedback in improving upper limb rehabilitation outcomes following stroke.
Read the detailed description
Upper limb paresis or plegia following stroke remains a significant cause of impairment and disability. Regaining function requires learning through repetitive movements and activities of daily living(ADLs).
The aim of the study in this application is to test the usability of the system in specialized rehabilitation hospital settings. In this first stage of development, after developing and testing the system together with expert physiotherapists, we will examine the system for usability (is it "user friendly"), comfort level, and therapeutic efficacy.
The system consists of an ordinary PC computer, specially written software, and a commercially available force feedback joystick. (Force feedback joysticks, are usually used for gaming; they contain miniature motors that allow the joystick to either help or resist the movements of the person using it). Patients who are unable to grasp the joystick will use a specially built arm rest that is attached to an ordinary office chair without wheels. Patients rest their forearm on the arm rest and thus can manipulate the joystick by means of movement of the shoulder and elbow joints instead of by movements of the wrist, since wrist movements are often difficult for brain damaged individuals.
- Conditions
- Stroke
- Being tested
- Exercise with force feedback joystick
- Keywords
- force feedback joystick, stroke, haptics, kinematics, rehabilitation, robotics, Force feedback joystick in 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.
Exercise with force feedback joystickDevice
System consists of a commercially available force feedback joystick, and specially written software. Patients will work with the system 5 times a week for 4 weeks, a half hour each time, 2 weeks with visual and haptic feedback and 2 weeks without the feedback.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer impairment scale
Measured: 1 month
Wolf Motor Function Test
Measured: One month
Secondary outcomes (1)
Satisfaction survey about the use of the joystick
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ono Academic College
- Investigators
- Shai Brill, M.D., Principal investigator, Beit Rivka Geriatric HospitalHeidi Sugarman, PhD, Study director, Ono Academic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758147
- Sponsor's protocol ID
- BGC085012CTIL
- Status last verified
- Sep 2008
- First submitted
- 21 Sep 2008
- Last updated
- 23 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Force Feedback Joystick in Upper Limb Rehabilitation Following Stroke
- ClinicalTrials.gov ID
- NCT00758147
- Acronym / sponsor ID
- BGC085012CTIL
- Conditions
- Stroke
- Keywords
- force feedback joystick, stroke, haptics, kinematics, rehabilitation, robotics, Force feedback joystick in stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Ono Academic College
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 23 Sep 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 assess the influence of force feedback joysticks and haptic feedback in improving upper limb rehabilitation outcomes following stroke.
Detailed description
Upper limb paresis or plegia following stroke remains a significant cause of impairment and disability. Regaining function requires learning through repetitive movements and activities of daily living(ADLs).
The aim of the study in this application is to test the usability of the system in specialized rehabilitation hospital settings. In this first stage of development, after developing and testing the system together with expert physiotherapists, we will examine the system for usability (is it "user friendly"), comfort level, and therapeutic efficacy.
The system consists of an ordinary PC computer, specially written software, and a commercially available force feedback joystick. (Force feedback joysticks, are usually used for gaming; they contain miniature motors that allow the joystick to either help or resist the movements of the person using it). Patients who are unable to grasp the joystick will use a specially built arm rest that is attached to an ordinary office chair without wheels. Patients rest their forearm on the arm rest and thus can manipulate the joystick by means of movement of the shoulder and elbow joints instead of by movements of the wrist, since wrist movements are often difficult for brain damaged individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 65 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Medically stable post first stroke patients
- Score of more than 17 on the Mini Mental Scale Test(MMST)
Key exclusion criteria (4 listed)
- A history of psychiatric illness
- Inability to understand the informed consent form
- Inability to understand and follow 2-3 step instructions
- Receptive aphasia (sensory aphasia)
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 |
|---|---|---|
| Exercise with force feedback joystickSystem consists of a commercially available force feedback joystick, and specially written software. Patients will work with the system 5 times a week for 4 weeks, a half hour each time, 2 weeks with visual and haptic feedback and 2 weeks without the feedback. | Device | – |
Primary outcome
Fugl Meyer impairment scale
Time frame: 1 month
Wolf Motor Function Test
Time frame: One month
1 secondary outcome
Satisfaction survey about the use of the joystick
Time frame: 1 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2008.
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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.
Shai Brill, M.D. principal investigator
Beit Rivka Geriatric Hospital
Heidi Sugarman, PhD study director
Ono Academic College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with force feedback joystick in people with Stroke, run by Rabin Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 23 Sep 2008. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer impairment scale (time frame: 1 month). The study lists 2 primary outcomes in all. 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 23 Sep 2008.