Hemiplegic StrokeIOTANCT01973426
Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis
An observational study of Hemiplegic Stroke and Hemiplegic Cerebral Palsy, run by Wyss Institute at Harvard University at 1 site in United States.
Trial summary
We plan to investigate whether the Isolated Orthosis for Thumb Actuation (IOTA) can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Hemiplegic Stroke, Hemiplegic Cerebral Palsy
- What is being tested?
- Isolated Orthosis for Thumb Actuation (IOTA)
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Nov 2017
- Phase
- Observational
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with hemiplegic cerebral palsy or hemiplegic stroke.
Who may be able to join
- Be between 7 - 16 years old
- Have a clinical diagnosis of hemiplegic cerebral palsy or hemiplegic stroke causing a thumb contracture affecting one hand
- Not have a diagnosis of dystonia
- Have completed at least a 6-week post-operative period following hand surgery (if applicable; self-reported)
- Be able to follow instructions (as determined by their attending Occupational Therapist)
- Not be allergic to nylon or lycra
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Development and Evaluation of a Human-Machine Interface for Grasp Assistance Using a Robotic Thumb Orthosis in Children With Hemiplegic Cerebral Palsy and Hemiplegic Stroke
We plan to investigate whether the Isolated Orthosis for Thumb Actuation (IOTA) can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting.
Read the detailed description
Many Activities of Daily Living involve precision grasp and fine motor manipulation, such as putting toothpaste on a toothbrush or feeding oneself. However, children afflicted by stroke, cerebral palsy, or traumatic brain injury may lose the ability to actively (and accurately) control the thumb, and specifically abduct/adduct the carpometacarpal (CMC) joint and flex/extend the metacarpophalangeal (MCP) joint. We are testing the Isolated Orthosis for Thumb Actuation (IOTA), a device developed at the Wyss Institute at Harvard University in collaboration with Children's Hospital Boston, for assisting opposable thumb grasping tasks. The IOTA contains an adjustable brace fitted to the thumb and dorsum of the hand that is easy to put on and facilitates grasping motions through flexible cable-driven actuators that assist with CMC joint abduction and MCP joint extension.
In this pilot study, we plan to investigate whether the IOTA can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting.
The hypothesis for this work is that the IOTA will significantly improve the participant's performance on clinically relevant tasks.
- Conditions
- Hemiplegic Stroke, Hemiplegic Cerebral Palsy
- Being tested
- Isolated Orthosis for Thumb Actuation (IOTA)
- Keywords
- Robot, Thumb, Orthosis, Hemiplegia, Hemiplegic Stroke, Hemiplegic Cerebral Palsy, Stroke, Cerebral Palsy, Grasp assistance
- Medical subject headings
- Hemiplegia, Stroke, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated Orthosis for Thumb Actuation (IOTA)Device
In this pilot study, we plan to investigate whether the IOTA can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting. The IOTA is a device developed at the Wyss Institute at Harvard University, in collaboration with Children's Hospital Boston, for assisting opposable thumb grasping tasks. The IOTA contains an adjustable brace fitted to the thumb and dorsum of the hand that is easy to put on and facilitates grasping motions through flexible cable-driven actuators that assist with joint abduction and extension.
| Study group | Role | What they receive |
|---|---|---|
| Children with limited control of their thumb | Children afflicted by hemiplegic stroke or hemiplegic cerebral palsy who have lost the ability to actively (and accurately) control the thumb. Receives: Device: Isolated Orthosis for Thumb Actuation (IOTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate whether the IOTA can effectively facilitate a participant's ability to perform a specific set of clinically relevant tasks in a clinical setting.
We will examine this aim by evaluating participant performance on a Box and Block Task. This task is clinically relevant to the participant population. This task will be evaluated with no device worn at first, and then with the IOTA device worn in four different modes (manual mode, cycle \& repeat mode, wrist mode, and moon mode).
Measured: 1 study session per participant, lasting up to 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyss Institute at Harvard University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Deborah Munroe Noonan Memorial Research Fund
- Responsible party
- Sponsor
- Investigators
- Leia Stirling, Ph.D., Principal investigator, Wyss Institute at Harvard UniversityAnnette Correia, OT, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973426
- Sponsor's protocol ID
- AMD-CS-0026
- Acronym
- IOTA
- Status last verified
- Jun 2020
- First submitted
- 24 Oct 2013
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Human-Machine Interface for Grasp Assistance Using a Robotic Thumb Orthosis in Children With Hemiplegic Cerebral Palsy and Hemiplegic Stroke
- ClinicalTrials.gov ID
- NCT01973426
- Acronym / sponsor ID
- IOTA / AMD-CS-0026
- Conditions
- Hemiplegic Stroke, Hemiplegic Cerebral Palsy
- Keywords
- Robot, Thumb, Orthosis, Hemiplegia, Hemiplegic Stroke, Hemiplegic Cerebral Palsy, Stroke, Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wyss Institute at Harvard UniversityUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Deborah Munroe Noonan Memorial Research Fund
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 31 Oct 2013 (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.
We plan to investigate whether the Isolated Orthosis for Thumb Actuation (IOTA) can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting.
Detailed description
Many Activities of Daily Living involve precision grasp and fine motor manipulation, such as putting toothpaste on a toothbrush or feeding oneself. However, children afflicted by stroke, cerebral palsy, or traumatic brain injury may lose the ability to actively (and accurately) control the thumb, and specifically abduct/adduct the carpometacarpal (CMC) joint and flex/extend the metacarpophalangeal (MCP) joint. We are testing the Isolated Orthosis for Thumb Actuation (IOTA), a device developed at the Wyss Institute at Harvard University in collaboration with Children's Hospital Boston, for assisting opposable thumb grasping tasks. The IOTA contains an adjustable brace fitted to the thumb and dorsum of the hand that is easy to put on and facilitates grasping motions through flexible cable-driven actuators that assist with CMC joint abduction and MCP joint extension.
In this pilot study, we plan to investigate whether the IOTA can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting.
The hypothesis for this work is that the IOTA will significantly improve the participant's performance on clinically relevant tasks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with limited control of their thumb | – | Device: Isolated Orthosis for Thumb Actuation (IOTA)Children afflicted by hemiplegic stroke or hemiplegic cerebral palsy who have lost the ability to actively (and accurately) control the thumb. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with hemiplegic cerebral palsy or hemiplegic stroke.
Key inclusion criteria (6 listed)
- Be between 7 - 16 years old
- Have a clinical diagnosis of hemiplegic cerebral palsy or hemiplegic stroke causing a thumb contracture affecting one hand
- Not have a diagnosis of dystonia
- Have completed at least a 6-week post-operative period following hand surgery (if applicable; self-reported)
- Be able to follow instructions (as determined by their attending Occupational Therapist)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Isolated Orthosis for Thumb Actuation (IOTA)In this pilot study, we plan to investigate whether the IOTA can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting. The IOTA is a device developed at the Wyss Institute at Harvard University, in collaboration with Children's Hospital Boston, for assisting opposable thumb grasping tasks. The IOTA contains an adjustable brace fitted to the thumb and dorsum of the hand that is easy to put on and facilitates grasping motions through flexible cable-driven actuators that assist with joint abduction and extension. | Device | Children with limited control of their thumb |
Primary outcome
Investigate whether the IOTA can effectively facilitate a participant's ability to perform a specific set of clinically relevant tasks in a clinical setting.
Time frame: 1 study session per participant, lasting up to 2 hours.
We will examine this aim by evaluating participant performance on a Box and Block Task. This task is clinically relevant to the participant population. This task will be evaluated with no device worn at first, and then with the IOTA device worn in four different modes (manual mode, cycle \& repeat mode, wrist mode, and moon mode).
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 9 Jun 2020.
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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.
Leia Stirling, Ph.D. principal investigator
Wyss Institute at Harvard University
Annette Correia, OT principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiplegic Stroke and Hemiplegic Cerebral Palsy, run by Wyss Institute at Harvard University 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 6 inclusion and 0 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 9 Jun 2020. 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?
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?
Investigate whether the IOTA can effectively facilitate a participant's ability to perform a specific set of clinically relevant tasks in a clinical setting. (time frame: 1 study session per participant, lasting up to 2 hours.). 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 9 Jun 2020.