Robotic Versus Conventional Training on Hemiplegic Gait. "BB200810"

Completed

Phase 3 Results N/A

Trial Description

The incidence of stroke in the industrial world is still high. Most of the patients are suffering from paresis of the affected side, speech and cognition problems. Modern concepts of motor learning after stroke favouring a task-specific repetitive high-intensity therapy approach to promote motor outcome. In the last couple of years robot-assisted therapy became an important part of modern rehabilitation after stroke. But so far there is no clear evidence that robot assisted therapy in combination with conventional therapy is more effective than conventional therapy alone to promote motor functions after stroke.

Conditions

Interventions

  • Conventional therapy Other
    Intervention Desc: conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks
    ARM 1: Kind: Experimental
    Label: Group A
    Description: Group A = conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks
  • Conventional plus robotic gait assisted therapy Device
    Other Names: Gait trainer GT1
    Intervention Desc: individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy
    ARM 1: Kind: Experimental
    Label: Group B
    Description: Group B = conventional therapy plus robot-assisted means: 30 min individual physiotherapy plus 20 min robot-assisted gait training and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional Ambulation Categories (FAC, 0-5) 4 weeks Yes
Primary Barthel index (BI, 0-100) 4 weeks Yes
Secondary Berg Balance Scale (BBS, 0-56 4 weeks Yes
Secondary REPAS -Muscle tone (REPAS, 0-52) 4 weeks Yes

Sponsors