StrokeNCT03020576
Robotic and Conventional Hand Therapy After Stroke
A study testing Amadeo Hand Robot Device and Conventional Therapy in people with Stroke, run by Columbia University at 2 sites in 2 countries.
Trial summary
Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are often not effective in restoring full function of the upper limb. Specifically, many individuals remain with weakness in the hand, preventing its return to full use. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Amadeo Hand Robot Device and Conventional Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2011to Mar 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of stroke (>3 months from time of ictus)
- paresis or plegia of the upper extremity.
Who cannot join
- severe spasticity (defined on the Ashworth Scale with a score of 4-5)
- severe pain despite conventional pain therapy of the paretic upper extremity
- swelling, infection, fracture or ulcers of the paretic extremity
- arthritis of the hand joints
- pregnant
- botulinum toxin- therapy to the upper extremity within 3 months prior to study entry
- severe contractions
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Robot-assisted Hand Training (Amadeo) Compared With Conventional Physiotherapy Techniques in Chronic Ischemic Stroke Patients: A Pilot Study
Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are often not effective in restoring full function of the upper limb. Specifically, many individuals remain with weakness in the hand, preventing its return to full use.
Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such as the InMotion2, have been shown to be useful in restoring some motor function in the upper limb. However, most existing devices designed to be used with the upper limb have primarily been developed to treat the shoulder, elbow and wrist. They have not specifically addressed hand function.
Read more
Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide rehabilitation for patients with neurological or orthopedic deficits in hand function. Initial clinical testing has demonstrated the practicality of using this device in a population of stroke survivors, although further research is needed to better understand the usefulness of the Amadeo device as compared with conventional rehabilitation methods. The purpose of this study was to compare results of training with the Amadeo device or training with conventional therapies.
A total of 28 subjects from two separate sites participated in the study and underwent baseline testing of upper limb motor and sensory performance and function. Subjects were then assigned to one of two treatment groups with a 50:50 chance of being in either group. One group underwent training with the Amadeo device and the other group underwent training with conventional therapy. All training sessions were 60 minutes in duration, three days/week for eight weeks (24 total sessions). Subjects were reassessed on completion of the training program.
- Conditions
- Stroke
- Being tested
- Amadeo Hand Robot Device, Conventional Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amadeo Hand Robot DeviceDevice
This is a robotic device designed to offer rehabilitation to remediate weakness and limitations of range of motion of the hand and fingers.
Conventional TherapyOther
This arm involves treatment using conventional methods designed to promote range of motion, strength, coordination and function at the level of the shoulder, elbow, wrist and hand.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | Active comparator | Participants randomized to this arm will receive conventional based therapy to their affected upper limb dose matched with the Robotic Therapy group. These interventions are aimed at increasing range of motion, strength and function at the shoulder, elbow, wrist and hand. Receives: Other: Conventional Therapy |
| Robotic Therapy | Experimental | Participants randomized to this arm will receive robotic based therapy using the Amadeo Hand Robot device to improve range of motion, strength, and coordination to the wrist and hand. Receives: Device: Amadeo Hand Robot Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer
quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.
Measured: Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)
Secondary outcomes (7)
Change in Range of Motion Measures
quantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)
Measured: Through study completion, an average of 8 weeks
Change in Hand and Pinch Strength
quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms
Measured: Through study completion, an average of 8 weeks
Change in Motor Activity Log Amount
quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.
Measured: Through study completion (taken at baseline and at 8-week study completion)
Change in Mobility and Activities of Daily Living
The Barthel Index is a quantitative scale measuring the need for assistance an individual has in performance of tasks of general mobility and activities of daily living. Maximum raw score is 100. Higher values represent better outcomes.
Measured: Through study completion (taken at baseline and at 8 week study completion)
Change in Hand Dexterity
The 9 Hole Peg Test was used as a quantitative measure of hand dexterity. The participant is asked to remove the pegs and put them back into the slots in a period of 100 sec. The number of pegs moved is recorded as an overall score.
Measured: Through study completion, an average of 8 weeks
Change in Spasticity Measures
The Modified Ashworth Scale is a standardized quantitative assessment of muscle tightness/spasticity during movements of the arm and wrist. It is scored on a scale of 1-5, with higher numbers reflecting a greater severity of spasticity.
Measured: Through study completion, an average of 8 weeks
Change in Motor Activity Log How Well
quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.
Measured: Through study completion (taken at baseline and on 8 week study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionMar 2016
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.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck, New York University
- Responsible party
- Principal investigator, Joel Stein, Columbia University
- Investigators
- Joel Stein, MD, Principal investigator, Columbia UniversityRaimund Helbok, MD, Principal investigator, Innsbruck Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020576
- Sponsor's protocol ID
- AAAI0093
- Status last verified
- Jan 2018
- First submitted
- 10 Jan 2017
- Last updated
- 25 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Hand Training (Amadeo) Compared With Conventional Physiotherapy Techniques in Chronic Ischemic Stroke Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03020576
- Acronym / sponsor ID
- AAAI0093
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Medical University Innsbruck, New York University
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 25 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are often not effective in restoring full function of the upper limb. Specifically, many individuals remain with weakness in the hand, preventing its return to full use.
Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such as the InMotion2, have been shown to be useful in restoring some motor function in the upper limb. However, most existing devices designed to be used with the upper limb have primarily been developed to treat the shoulder, elbow and wrist. They have not specifically addressed hand function.
Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide rehabilitation for patients with neurological or orthopedic deficits in hand function. Initial clinical testing has demonstrated the practicality of using this device in a population of stroke survivors, although further research is needed to better understand the usefulness of the Amadeo device as compared with conventional rehabilitation methods. The purpose of this study was to compare results of training with the Amadeo device or training with conventional therapies.
A total of 28 subjects from two separate sites participated in the study and underwent baseline testing of upper limb motor and sensory performance and function. Subjects were then assigned to one of two treatment groups with a 50:50 chance of being in either group. One group underwent training with the Amadeo device and the other group underwent training with conventional therapy. All training sessions were 60 minutes in duration, three days/week for eight weeks (24 total sessions). Subjects were reassessed on completion of the training program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | Active comparator | Other: Conventional TherapyParticipants randomized to this arm will receive conventional based therapy to their affected upper limb dose matched with the Robotic Therapy group. These interventions are aimed at increasing range of motion, strength and function at the shoulder, elbow, wrist and hand. |
| Robotic Therapy | Experimental | Device: Amadeo Hand Robot DeviceParticipants randomized to this arm will receive robotic based therapy using the Amadeo Hand Robot device to improve range of motion, strength, and coordination to the wrist and hand. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- history of stroke (>3 months from time of ictus)
- paresis or plegia of the upper extremity.
Key exclusion criteria (7 listed)
- severe spasticity (defined on the Ashworth Scale with a score of 4-5)
- severe pain despite conventional pain therapy of the paretic upper extremity
- swelling, infection, fracture or ulcers of the paretic extremity
- arthritis of the hand joints
- pregnant
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 |
|---|---|---|
| Amadeo Hand Robot DeviceThis is a robotic device designed to offer rehabilitation to remediate weakness and limitations of range of motion of the hand and fingers. | Device | Robotic Therapy |
| Conventional TherapyThis arm involves treatment using conventional methods designed to promote range of motion, strength, coordination and function at the level of the shoulder, elbow, wrist and hand. | Other | Conventional Therapy |
Primary outcome
Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer
Time frame: Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)
quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.
7 secondary outcomes
Change in Range of Motion Measures
Time frame: Through study completion, an average of 8 weeks
Change in Hand and Pinch Strength
Time frame: Through study completion, an average of 8 weeks
Change in Motor Activity Log Amount
Time frame: Through study completion (taken at baseline and at 8-week study completion)
Change in Mobility and Activities of Daily Living
Time frame: Through study completion (taken at baseline and at 8 week study completion)
Change in Hand Dexterity
Time frame: Through study completion, an average of 8 weeks
Change in Spasticity Measures
Time frame: Through study completion, an average of 8 weeks
Change in Motor Activity Log How Well
Time frame: Through study completion (taken at baseline and on 8 week study completion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
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Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
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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.
Joel Stein, MD principal investigator
Columbia University
Raimund Helbok, MD principal investigator
Innsbruck Medical University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amadeo Hand Robot Device and Conventional Therapy in people with Stroke, run by Columbia University at 2 sites in 2 countries.
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 7 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 25 Jan 2018. 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, Austria. 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 25 Jan 2018). 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?
Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer (time frame: Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)). 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 25 Jan 2018.