At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CSP #558 - Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
In Brief
A Phase 2 clinical trial evaluating Robot-Assisted Therapy - MIT-MANUS System, Intensive Comparison Therapy, and 1 other intervention for Stroke. Completed, enrolled 127 participants across 5 sites.
Detailed Summary
This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.
Study Details
Timeline
Interventions
The MIT-MANUS robot consists of four modules to train the entire upper limb: module A: shoulder-elbow; module B: anti-gravity; module C: wrist, and module D: hand-unit. Training will be given for 12 weeks and is divided into 4 consecutive blocks, with 9 training sessions per block.
The intensive comparison therapy protocol being used in CSP#558 was developed and field-tested at the Burke Rehabilitation Hospital. It exposes the patient to the identical number of treatments, time, and intensity that robot treated patients will receive (12 weeks, 3 times per week). Therapy sessions can be conducted on back-to-back days if needed and on more than 3 days a week (with approval from the Study Chairman) over a treatment period of up to 14 weeks in order to complete the 36 treatment sessions. During each 1-hour session, subjects participate in therapy in four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques (NDT)/Bobath arm training (Bobath, 1979).
The usual chronic stroke care as delivered at each participating medical center