Locomotor Training With Robotic Gait in Stroke

Recruiting

Phase N/A Results N/A

Trial Description

The objective of this study is to compare the effects of novel versus conventional locomotor training using a robotic gait orthosis (LT-RGO) after stroke. The novel LT-RGO protocol imposes progressive decrease of speed and guidance force as compared with the conventional protocol which is the progressive increase of LT-RGO speed with progressive decrease of guidance force. The hypothesis is that the novel LT-RGO protocol, by establishing a progressive decrease in gait velocity and guidance force, may facilitate greater motor recovery compared to the use of a conventional protocol.

Conditions

Interventions

  • Novel Protocol Procedure
    ARM 1: Kind: Experimental
    Label: Novel Protocol
    Description: Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.
  • Conventional Protocol Procedure
    ARM 1: Kind: Experimental
    Label: Conventional Protocol
    Description: Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional Ambulation Scale (FAC) Baseline and 6 weeks No
Secondary Six-minute Walking Test (6MWT) Baseline and 6 weeks No
Secondary Time Up and Go (TUG) Baseline and 6 weeks No
Secondary Ten-meters Walking Test (10MWT) Baseline and 6 weeks No
Secondary Lower Limbs Fugl-Meyer Baseline and 6 weeks No
Secondary Berg Scale Baseline and 6 weeks No
Secondary Functional Independence Measure Baseline and 6 weeks No

Sponsors