Hemiplegic Cerebral Palsy Clinical Trial
— IOTAOfficial 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
NCT number | NCT01973426 |
Other study ID # | AMD-CS-0026 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | November 2017 |
Verified date | June 2020 |
Source | Wyss Institute at Harvard University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | November 2017 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 16 Years |
Eligibility |
Inclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Wyss Institute at Harvard University | Boston Children’s Hospital, Deborah Munroe Noonan Memorial Research Fund |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 1 study session per participant, lasting up to 2 hours. |
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