The General Use of Robots in Stroke Recovery

Withdrawn

Phase N/A Results N/A

Trial Description

The purpose of this study is to determine if tailoring multiple sessions of upper extremity robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming; active range of motion vs. functional practice)can optimize therapeutic results and lead to greater functional returns in arm mobility after stroke.

Trial Stopped: Unfunded

Conditions

Interventions

  • IMT Robotic Arm therapy Device
    Intervention Desc: Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy
    ARM 1: Kind: Experimental
    Label: IMT Robotic Arm Therapy: Aim training
    Description: Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks.
    ARM 2: Kind: Experimental
    Label: IMT Robotic Arm Therapy: Smoothness Training
    Description: Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks.
    ARM 3: Kind: Experimental
    Label: IMT Robotic Arm Therapy: Impairment training
    Description: Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks.
    ARM 4: Kind: Experimental
    Label: IMT Robotic Arm Therapy: Functional training
    Description: Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in Upper Extremity Fugl Meyer Motor Assessment 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention) No
Secondary Change from baseline in Kinematic Data 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention) No
Secondary Change from baseline in Fugl Meyer Sensation Scale 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention) No
Secondary Change from baseline in Fugl Meyer Proprioception Scale 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention) No

Sponsors