CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
Robot Therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01253018
NCT01253018Phase 2Completed

Evaluation of Robot Assisted Neuro-rehabilitation

VA Office of Research and Development·interventional·Posted Dec 3, 2010·Updated Oct 30, 2019

In Brief

A Phase 2 clinical trial evaluating Robot Therapy and Transition to Task Training for Stroke. Completed, enrolled 59 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 3, 2010
Enrollment StartApr 27, 2011
Primary CompletionJan 16, 2015
Study CompletionJan 30, 2015
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 15.6 years ago

Interventions

Robot Therapybehavioral

Robot assisted arm exercise for 60 minutes progressing each month through three robot modules: wrist, planar, and alternating sessions on the wrist and planar robot 3x/week for 12 weeks.

Transition to Task Trainingbehavioral

Robot therapy as described for 45 minutes and 15 minutes of task specific arm exercise using the hemiparetic arm 3x/week for 12 weeks.