Automated Versus Standard Physiotherapy for Upper Limb Rehabilitation in Patients With Acquired Brain Lesions

Withdrawn

Phase N/A Results N/A

Trial Description

The Armeo Spring has proven its effectiveness in the rehabilitation of acute stroke patients. It neutralizes limb weight, enabling patients to use residual control in both arm and hand and to follow exercises guided by simulations of real-life challenges. The Armeo Spring incorporates wrist pronation and supination, allowing patients to enhance functional reaching patterns.
Aim of the study is to compare the Armeo device with standard physiotherapy in chronic patients with acquired brain lesions.
The result of the trial should show which treatment is more effective in the clinical practice. A significant better outcome of one arm should suggest to follow one treatment strategy more than the other.

Trial Stopped: the human resources in the organisation are to limited to do the trial

Conditions

Interventions

  • ARMEO Spring Device
    Intervention Desc: 30min Armeo Spring + 15min task oriented therapy over 6 weeks Frequency: 3 x/week
    ARM 1: Kind: Experimental
    Label: Armeo Spring
  • Conventional physiotherapy Behavioral
    Intervention Desc: 30min occupational therapy(15min ADL-training, 15min repetitive training) + 15min task oriented therapy over 6 weeks Frequency: 3x/week
    ARM 1: Kind: Experimental
    Label: conventional physiotherapy

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 Fugl Meyer Score for sensorymotor recovery of the upper limb after stroke Enrollment Yes
Secondary Upper Extremity Motor Activity Log for measuring real use of the upper limb Enrolment Yes
Secondary Wolf Motor Function Test for measurement of timed joint-segment movements Enrolment Yes
Secondary Clinical Global Impression Score for the measurement of change over time of the illness' severity Enrolment Yes

Sponsors