N/A
N=31
FINGER Robot Therapy Study
Cerebrovascular Accident
Bottom Line
View on ClinicalTrials.gov: NCT02048826 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed — 2.3; 2.4 blocks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FINGER I (Device); FINGER II (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed |
2.3; 2.4 | — |
| SECONDARY Motor and Strength Measure Using Action Research Arm Test Measured as a Score |
2.5; 3.5 | — |
| SECONDARY Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score |
3.7; 1.8 | — |
Summary
The purpose of this study is to determine the effectiveness of training hand movement using FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users to play computer games using those movements.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 80 years of age
- Have history of stroke affecting the arm, at least 6 months prior to enrollment
- have arm and/or hand weakness as measured on a standard clinical scale
- do not have active major psychological problems, or problems affecting the stroke-affected arm or hand besides the stroke
- do not have active major brain disease other than the stroke
- have absence of pain in the stroke-affected arm and hand
Exclusion Criteria
- severe stiffness of the arm or hand as measured on a standard clinical scale
- severe problems speaking or understanding speech as measured on a standard clinical scale
- severe reduced level of consciousness
- severe loss ability to sense movement of your limbs as measured on a standard clinical scale
- currently pregnant
- difficulty in understanding or complying with the instructions given by the researcher
- inability to perform the experimental task that will be studied
- increased pain with movement of the stroke-affected arm or hand
Exclusion criteria that will prevent subjects from participating in the MRI:
- Subjects having any implanted metal such as metallic splinters, metallic surgical clips, prosthetic heart valves, pacemakers, neuro-stimulation devices, orthodontic work that contains ferromagnetic materials,
- Subjects whose occupation or activities may cause accidental lodging of ferromagnetic materials, or that may have imbedded metal fragments from military activities, unless cleared by a screening head CT scan
- Subjects with tattoo(s) presenting metallic or ferromagnetic color ingredients or with facial make-up
- Subjects who have claustrophobia
- Subjects who are currently pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT02048826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.