Cerebrovascular AccidentNCT00435617
Study of Hand Therapy 3 to 24 Months After Stroke
A study testing Hand Mentor in people with Cerebrovascular Accident, run by Kinetic Muscles at 2 sites in United States.
Trial summary
The primary aim of this study is to investigate the effectiveness of the use of a robotic hand therapy device in the home environment. We hypothesize that the therapy group will improve hand function more than a customary and usual care group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Hand Mentor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2005to May 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3 to 24 months post stroke
- Able to extend wrist and fingers at least 10 degrees
- Functional hearing and vision
- Able to follow instructions
- Lives at home, not institution
- Stable medications for 3 months
Who cannot join
- Excessive cognitive impairments
- Taking/Receiving medicines/shots to make arm/hand less stiff
- Severe pain in the impaired arm
- Stroke was more than 24 months ago
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University
Atlanta, Georgia, 30322
Arizona State University, College of Nursing & Healthcare Innovation
Phoenix, Arizona, 85004
About this study
Official title: Clinical Assessment of a Massed Practice Therapy Device
The primary aim of this study is to investigate the effectiveness of the use of a robotic hand therapy device in the home environment. We hypothesize that the therapy group will improve hand function more than a customary and usual care group.
Read the detailed description
Many stroke survivors have significant limitations of upper extremity function which impacts many important activities such as eating, dressing and personal care. Studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. Robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. Seventy subjects (3 to 12 months post stroke)are being randomized to a control group that utilizes an innovative robotic hand therapy device in the home for three months or a control group that receives no device treatment. Clinical motor function and quality of life measures will compare the groups before intervention, immediately after, and 3 months later. The control group will receive device treatment for 3 months following their final evaluation. The results will provide valuable data on the ability of monitored home therapy to provide effective treatment. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.
- Conditions
- Cerebrovascular Accident
- Being tested
- Hand Mentor
- Keywords
- stroke rehabilitation, stroke therapy, hand therapy, stroke, cerebrovascular stroke, cerebral stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand MentorDevice
Also called Hand Mentor Home
Use of the Hand Mentor therapy device at home for 6 weeks. Therapy programs include spasticity reduction, motor control, and emg biofeedback for encouraging activity.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Hand Mentor Receives: Device: Hand Mentor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
Measured: Initial, 6 wks, 12 wks, 16 wks, 52 wks
Secondary outcomes (3)
Compliance with recommended use
Measured: 6 wks, 12 wks
Fugl-Meyer Test
Measured: Initial, 6 wks, 12 wks, 16 wks, 52 wks
Stoke Impact Scale
Measured: Initial, 6 wks, 12 wks, 16 wks, 52 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startMay 2005
- Primary completionMay 2009
- Study completionMay 2010
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 Cerebrovascular AccidentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinetic Muscles
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, James Koeneman, Kinetic Muscles
- Investigators
- James B Koeneman, Ph.D., Principal investigator, Kinetic Muscles, Inc.Steven L Wolf, Ph.D., PT, Study director, Emory University Medical SchoolRichard Herman, MD, Study director, Banner Good Samaritan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435617
- Sponsor's protocol ID
- R44HD041805
- Other IDs
- R44HD041805
- Status last verified
- Jul 2012
- First submitted
- 13 Feb 2007
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Frick EM, Alberts JL. Combined use of repetitive task practice and an assistive robotic device in a patient with subacute stroke. Phys Ther. 2006 Oct;86(10):1378-86. doi: 10.2522/ptj.20050149.
PubMed 17012642
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of a Massed Practice Therapy Device
- ClinicalTrials.gov ID
- NCT00435617
- Acronym / sponsor ID
- R44HD041805
- Conditions
- Cerebrovascular Accident
- Keywords
- stroke rehabilitation, stroke therapy, hand therapy, stroke, cerebrovascular stroke, cerebral stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Kinetic MusclesIndustry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 15 Feb 2007 (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 primary aim of this study is to investigate the effectiveness of the use of a robotic hand therapy device in the home environment. We hypothesize that the therapy group will improve hand function more than a customary and usual care group.
Detailed description
Many stroke survivors have significant limitations of upper extremity function which impacts many important activities such as eating, dressing and personal care. Studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. Robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. Seventy subjects (3 to 12 months post stroke)are being randomized to a control group that utilizes an innovative robotic hand therapy device in the home for three months or a control group that receives no device treatment. Clinical motor function and quality of life measures will compare the groups before intervention, immediately after, and 3 months later. The control group will receive device treatment for 3 months following their final evaluation. The results will provide valuable data on the ability of monitored home therapy to provide effective treatment. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Hand MentorHand Mentor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 3 to 24 months post stroke
- Able to extend wrist and fingers at least 10 degrees
- Functional hearing and vision
- Able to follow instructions
- Lives at home, not institution
Key exclusion criteria (4 listed)
- Excessive cognitive impairments
- Taking/Receiving medicines/shots to make arm/hand less stiff
- Severe pain in the impaired arm
- Stroke was more than 24 months ago
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 |
|---|---|---|
| Hand MentorAlso: Hand Mentor HomeUse of the Hand Mentor therapy device at home for 6 weeks. Therapy programs include spasticity reduction, motor control, and emg biofeedback for encouraging activity. | Device | A |
Primary outcome
Wolf Motor Function Test
Time frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks
3 secondary outcomes
Compliance with recommended use
Time frame: 6 wks, 12 wks
Fugl-Meyer Test
Time frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks
Stoke Impact Scale
Time frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
- Background: PubMed 17012642Frick EM, Alberts JL. Combined use of repetitive task practice and an assistive robotic device in a patient with subacute stroke. Phys Ther. 2006 Oct;86(10):1378-86. doi: 10.2522/ptj.20050149.
Related trials for Cerebrovascular Accident
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
James B Koeneman, Ph.D. principal investigator
Kinetic Muscles, Inc.
Steven L Wolf, Ph.D., PT study director
Emory University Medical School
Richard Herman, MD study director
Banner Good Samaritan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Mentor in people with Cerebrovascular Accident, run by Kinetic Muscles at 2 sites 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 6 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: finished, as of the sponsor's last update on 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wolf Motor Function Test (time frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks). 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 NCT00435617, 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 20 Jul 2012.