NCT02359253 · University of Maryland, Baltimore
Robot Aided Rehabilitation - Intervention
(Aim2&3)
What this study is about
Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the treatment group$1 and hand, thereby rendering them difficult to diagnose and treat.
View original scientific description
Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training.
Interventions
OTHER
Passive stretching
Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot within preset ranges of motion.
OTHER
Passive movement
Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot only within ranges that produce no to very minimal forces.
OTHER
IntelliArm
During the active training, subjects will be asked to actively move their arm while supported with IntelliArm robot to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance.
OTHER
Hand robot
During the active training, subjects will be asked to actively open and close their hand with the hand robot on while participating in task oriented occupational therapy focused on grasp and release tasks. The hand robot may provide resistance or assistance.
Primary outcome measures
Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points
Time frame: Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention
The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- First focal unilateral lesion, ischemic or hemorrhagic
- Had a stroke 1-12 months prior to enrollment
- Rated between stages 2-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm and Hand
Exclusion criteria
- Score of less than 22 on the Mini Mental Status Exam
- Severe pain in the shoulder by a self-rating of 7 out of 10 or greater
- Severe contracture in the upper extremity
- Unable to sit in a chair for 3 consecutive hours
- Unrelated musculoskeletal injuries
- Poor fit into equipment used in study
- Botox injection in upper extremity within 4 months
- Concurrent participation in gait or upper extremity intervention studies
Where
- Baltimore, Maryland
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research, North Carolina State University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2025 · Source of record for eligibility and locations