StrokePhase 4HAAPINCT01144715
Rehabilitation of the Stroke Hand at Home
A Phase 4 study testing Hand Mentor (TM) robotic stroke therapy device and Home Therapy Program in people with Stroke, run by Kinetic Muscles at 2 sites in United States.
Trial summary
The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Hand Mentor (TM) robotic stroke therapy device and Home Therapy Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Sep 2013
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral ischemic or hemorrhagic stroke
- within 6 months of admission to in-patient rehabilitation
- Persistent hemiparesis
- Proximal Upper Extremity voluntary activity
- Preserved cognitive function
- Difficult access to an organized stroke rehabilitation program
Who cannot join
- Not independent before stroke
- Hemispatial neglect
- Significant other illnesses
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Cleveland Clinic Foujndation
Cleveland, Ohio, 44195
About this study
Official title: An Innovative Home Stroke Rehabilitation and Monitoring System
The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. The robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than Usual and Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation program at the end of 8 weeks of home therapy.
Read the detailed description
The primary purpose of this proposal is to evaluate a combined clinic/home robotic-based stroke therapy delivery and monitoring system in rural and underserved locations that provides accessible, effective and affordable care for stroke survivors with residual limb impairment. The study is a prospective, single-blind, multi-site Randomized Controlled Trial. A total of 96 patients within 6 months post-stroke will be enrolled and randomly assigned to one of two groups: robotic based home therapy or a self administered (non-robotic) home therapy program.
- Conditions
- Stroke
- Being tested
- Hand Mentor (TM) robotic stroke therapy device, Home Therapy Program
- Keywords
- Stroke Rehabilitation, Home rehabilitation, robotic therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Mentor (TM) robotic stroke therapy deviceDevice
The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.
Home Therapy ProgramDevice
Subjects in the control group will be instructed in a self administered home therapy program
| Study group | Role | What they receive |
|---|---|---|
| Hand Mentor Therapy | Experimental | Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks Receives: Device: Hand Mentor (TM) robotic stroke therapy device |
| Control | Active comparator | Self administered home therapy program Receives: Device: Home Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.
Measured: End of treatment at 8 weeks post enrolment
Secondary outcomes (3)
Wolf Motor Function Test
The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome.
Measured: End of treatment at 8 weeks post enrolment
Fugl-Meyer Upper Extremity Test
Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0-2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66.
Measured: End of Treatment at 8 weeks post enrolment
Stroke Impact Scale (SIS)
Quality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function.
Measured: End of treatment at 8 weeks post enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2013
- Study completionSep 2013
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 (3)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinetic Muscles
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic, Emory University, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Jay Alberts, PhD, Principal investigator, The Cleveland ClinicSteve L Wolf, PhD, Principal investigator, Emory University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144715
- Sponsor's protocol ID
- NS070646
- Other IDs
- 1RC3NS070646-01
- Acronym
- HAAPI
- Status last verified
- Oct 2014
- First submitted
- 11 Jun 2010
- Last updated
- 27 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Linder SM, Rosenfeldt AB, Bay RC, Sahu K, Wolf SL, Alberts JL. Improving Quality of Life and Depression After Stroke Through Telerehabilitation. Am J Occup Ther. 2015 Mar-Apr;69(2):6902290020p1-10. doi: 10.5014/ajot.2015.014498.
PubMed 26122686Wolf SL, Sahu K, Bay RC, Buchanan S, Reiss A, Linder S, Rosenfeldt A, Alberts J. The HAAPI (Home Arm Assistance Progression Initiative) Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):958-68. doi: 10.1177/1545968315575612. Epub 2015 Mar 17.
PubMed 25782693Linder SM, Rosenfeldt AB, Reiss A, Buchanan S, Sahu K, Bay CR, Wolf SL, Alberts JL. The home stroke rehabilitation and monitoring system trial: a randomized controlled trial. Int J Stroke. 2013 Jan;8(1):46-53. doi: 10.1111/j.1747-4949.2012.00971.x.
PubMed 23280269
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Home Stroke Rehabilitation and Monitoring System
- ClinicalTrials.gov ID
- NCT01144715
- Acronym / sponsor ID
- HAAPI / NS070646
- Conditions
- Stroke
- Keywords
- Stroke Rehabilitation, Home rehabilitation, robotic therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Kinetic MusclesIndustry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic, Emory University, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Posted 27 Nov 2014
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 research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. The robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than Usual and Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation program at the end of 8 weeks of home therapy.
Detailed description
The primary purpose of this proposal is to evaluate a combined clinic/home robotic-based stroke therapy delivery and monitoring system in rural and underserved locations that provides accessible, effective and affordable care for stroke survivors with residual limb impairment. The study is a prospective, single-blind, multi-site Randomized Controlled Trial. A total of 96 patients within 6 months post-stroke will be enrolled and randomly assigned to one of two groups: robotic based home therapy or a self administered (non-robotic) home therapy program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand Mentor Therapy | Experimental | Device: Hand Mentor (TM) robotic stroke therapy deviceUse of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks |
| Control | Active comparator | Device: Home Therapy ProgramSelf administered home therapy program |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral ischemic or hemorrhagic stroke
- within 6 months of admission to in-patient rehabilitation
- Persistent hemiparesis
- Proximal Upper Extremity voluntary activity
- Preserved cognitive function
Key exclusion criteria (3 listed)
- Not independent before stroke
- Hemispatial neglect
- Significant other illnesses
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 Mentor (TM) robotic stroke therapy deviceThe goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance. | Device | Hand Mentor Therapy |
| Home Therapy ProgramSubjects in the control group will be instructed in a self administered home therapy program | Device | Control |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: End of treatment at 8 weeks post enrolment
The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.
3 secondary outcomes
Wolf Motor Function Test
Time frame: End of treatment at 8 weeks post enrolment
Fugl-Meyer Upper Extremity Test
Time frame: End of Treatment at 8 weeks post enrolment
Stroke Impact Scale (SIS)
Time frame: End of treatment at 8 weeks post enrolment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26122686Linder SM, Rosenfeldt AB, Bay RC, Sahu K, Wolf SL, Alberts JL. Improving Quality of Life and Depression After Stroke Through Telerehabilitation. Am J Occup Ther. 2015 Mar-Apr;69(2):6902290020p1-10. doi: 10.5014/ajot.2015.014498.
- Derived from this study: PubMed 25782693Wolf SL, Sahu K, Bay RC, Buchanan S, Reiss A, Linder S, Rosenfeldt A, Alberts J. The HAAPI (Home Arm Assistance Progression Initiative) Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):958-68. doi: 10.1177/1545968315575612. Epub 2015 Mar 17.
- Derived from this study: PubMed 23280269Linder SM, Rosenfeldt AB, Reiss A, Buchanan S, Sahu K, Bay CR, Wolf SL, Alberts JL. The home stroke rehabilitation and monitoring system trial: a randomized controlled trial. Int J Stroke. 2013 Jan;8(1):46-53. doi: 10.1111/j.1747-4949.2012.00971.x.
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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.
Jay Alberts, PhD principal investigator
The Cleveland Clinic
Steve L Wolf, PhD principal investigator
Emory University Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hand Mentor (TM) robotic stroke therapy device and Home Therapy Program in people with Stroke, 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 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: finished, as of the sponsor's last update on 27 Nov 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2014). 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?
Action Research Arm Test (ARAT) (time frame: End of treatment at 8 weeks post enrolment). 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 NCT01144715, which also lists 3 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 27 Nov 2014.