Phase 2
Completed N=45
Evaluation of Robot Assisted Neuro-Rehabilitation
Source: ClinicalTrials.gov NCT01253018 ↗Enrolled (actual)
45
Serious AEs
16.3%
Results posted
Jan 2016
Primary outcomePrimary: Fugl-Meyer Motor Upper Extremity Assessment — 2.7; 3.7; 3.7; 3.5 units on a scale — p=<0.05
Summary
Robotic devices are capable of providing therapy to the arm of patients with weakness due to stroke. Robotic therapy improves some aspects of stroke related arm weakness, but the use of the weak arm for real life situations often remains limited. The goal of this study is to determine the best way to use robotic devices and functional task training to improve the use of the stroke affected arm for real life situations. A secondary goal of this study is to determine how or if specific areas of the brain are excited before and after training. The use of a safe and painless magnetic field directed at the brain called transcranial magnetic stimulation (TMS) will be used at set intervals to gain a better understanding of brain activity during recovery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Motor Upper Extremity Assessment |
2.7; 3.7; 3.7; 3.5 | <0.05 sig |
| SECONDARY Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS) |
— | — |
| SECONDARY Wolf Motor Function Test (WMFT) |
-5.1; -9.4; -7.6; -8.6 | <0.05 sig |
| SECONDARY Stroke Impact Scale: Hand Subscale |
5.8; 15.5; 7.8; 13.8 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnoses
- Adequate language, and cognitive function to participate in training, testing, and informed consent process
- The study arm of the participant will present with moderate to severe dysfunction based on Fugl-Meyer Motor Assessment range of 7 to 38
- Stroke onset greater than 6 months for ischemic stroke and greater than 1 year for hemorrhagic stroke
- Men or women over 21 years of age
Exclusion Criteria
- Seizures or treatment with anticonvulsant medications within the last 10 years (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing)
- Treatment with any medications known to interfere with brain stimulation: any medication with central nervous system depressant activity, including, but not limited to benzodiazepines, barbiturates, and neuroleptics (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing)
- Serious complicating medical conditions, contractures or orthopedic problems in the study arm limiting the range of joint movement for the study positions
- Visual loss such that the participant cannot see the test patterns on the monitor of the training robot computer
- Botox injection to the study arm within 3 months of enrollment or during the study period
- Any change in the exercise regime involving the study arm. This includes starting any new exercise or discontinuing any current exercise regimen
Data sourced from ClinicalTrials.gov (NCT01253018). 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. Informational only — not medical advice.