Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise

Completed

Phase N/A Results

Trial Description

The propose of this study is to evaluate the feasibility and the clinical efficiency of feedback-controlled robotics-assisted treadmill exercise (RATE) technology for cardiovascular rehabilitation early after stroke. The investigators hypothesize that feedback-controlled RATE might be suitable and effective to improve cardiovascular fitness and functional carryover in non-ambulatory individuals with sub-acute stroke.

Detailed Description

For detailed info: Stoller O, de Bruin ED, Schuster-Amft C, Schindelholz M, de Bie RA, Hunt KJ. Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomized controlled pilot trial. Trials. 2013 Sep 22;14(1):304.

Conditions

Interventions

  • Feedback-controlled robotics-assisted treadmill exercise Device
    Other Names: Lokomat system (Hocoma AG, Volketswil, Switzerland)
    Intervention Desc: Progressive cardiovascular exercise using feedback-controlled robotics-assisted treadmill exercise. The first training session is defined to start at 40% of peak work rate (determined from a previous exercise test) to approach 40% of heart rate reserve (Borg scale approximately 11-14). The intensity will then be adjusted on the basis of continuous heart rate data and rating of perceived exertion indications by modulating the target work rate in 5% increments for every subsequent session to reach the target intensity. The target heart rate is set at 40% to 70% of heart rate reserve.
    ARM 1: Kind: Experimental
    Label: FC-RATE
    Description: Feedback-controlled robotics-assisted treadmill exercise
  • Robotics-assisted treadmill exercise Device
    Other Names: Lokomat system (Hocoma AG, Volketswil, Switzerland)
    Intervention Desc: Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only.
    ARM 1: Kind: Experimental
    Label: RATE
    Description: Robotics-assisted treadmill exercise

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Aerobic capacity Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks No
Secondary 10 Meter Walk Test (gait speed) Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks No
Secondary 6 Minute Walk Test (walking endurance) Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks No
Secondary Standing function (balance) Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks No
Secondary Locomotor functions (maximum voluntary isometric contraction, range of motion, spasticity) Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks No
Secondary Stroke Impact Scale (stroke recovery) Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks No
Secondary Feasibility (criteria for success) Baseline (T0), after 4 weeks intervention (T1, Tx, Tx..), at clinical discharge (Tx) / Expected time to clinical discharge: 8 weeks No
Primary Peak Oxygen Uptake (V'O2peak) 4 weeks No

Sponsors