To justify their use, new neuro-rehabilitation methods must be validated with rigorous clinical trials. Using a prospective, controlled, blinded protocol, our previous study; " Mechanically assisted upper limb movement for assessment and therapy", demonstrated a greater, more rapid movement in upper limb motor recovery when therapy was delivered with robot assistance, compared to traditional training of equal intensity and duration in subjects with chronic hemiplegia.

Although the effectiveness of robot-assisted therapy has now been independently demonstrated significant differences exist in the methods used and populations studied.

This study will test the following hypotheses:

(1) Subjects using the novel, upper limb robotic system developed by the VA and Stanford University (MIME system) experience greater functional gains than a control group receiving conventional therapy of equal intensity and duration during the initial phase of recovery from stroke.

(2) Robot assisted therapy results in a dose-dependent response.

(3) Robot-assisted therapy promotes greater control of movement, greater recovery of strength, and greater reduction of co-contraction than the control intervention.

The above hypotheses will be tested through a multi-site clinical trial conducted at the VA Rehabilitation Centers in Houston, Los Angeles,and Palo Alto. Palo Alto Center will serve as the coordinating site and will provide training and technical assistance.

Condition	Treatment or Intervention	Phase
Cerebrovascular Accident	Procedure: Neuro-Rehabilitation	Phase II

Further Study Details: 

Expected Total Enrollment:  102

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Spinal cord injury

California
      VA Medical Center, Palo Alto,  California,  United States; Recruiting

Study chairs or principal investigators

David Wolff, Ph.D. Special Assistant to the Director,  Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service   
Danielle Kerkovitch, Ph.D.,  Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service   

Study ID Numbers:  B2695
Record last reviewed:  May 2002
Last Updated:  October 13, 2004
Record first received:  May 30, 2002
ClinicalTrials.gov Identifier:  NCT00038324
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08