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

This study has been completed.
Sponsor:
Collaborators:
Maastricht University
Reha Rheinfelden
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
Oliver Stoller, Bern University of Applied Sciences
ClinicalTrials.gov Identifier:
NCT01679600
First received: August 29, 2012
Last updated: July 30, 2015
Last verified: July 2015
Results First Received: July 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stroke
Cardiovascular Diseases
Interventions: Device: Feedback-controlled robotics-assisted treadmill exercise
Device: Robotics-assisted treadmill exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
6 subjects dropped out before assiggnment (abnormal gait pattern due to uncontrollable spasticity, tibia skin lesion due to inadequate padding during familiarization, lack of motivation to produce maximal work rate values, severe groin pain caused by the body weight support harness, suspected cerebrospinal fluid leak, acute respiratory infection)

Reporting Groups
  Description
FC-RATE

Feedback-controlled robotics-assisted treadmill exercise

Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate

RATE

Robotics-assisted treadmill exercise

Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise


Participant Flow:   Overall Study
    FC-RATE     RATE  
STARTED     7     7  
COMPLETED     7     7  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
FC-RATE

Feedback-controlled robotics-assisted treadmill exercise

Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate

RATE

Robotics-assisted treadmill exercise

Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise

Total Total of all reporting groups

Baseline Measures
    FC-RATE     RATE     Total  
Number of Participants  
[units: participants]
  7     7     14  
Age  
[units: years]
Mean (Standard Deviation)
  57  (12)     63  (13)     61  (11)  
Gender  
[units: participants]
     
Female     4     1     5  
Male     3     6     9  
Region of Enrollment  
[units: participants]
     
Switzerland     7     7     14  
Type of stroke: ischemic/hemorrhagic  
[units: participants]
     
ischemic     5     7     12  
hemorrhagic     2     0     2  
Hemiparetic side: right/left  
[units: participants]
     
right     5     2     7  
left     2     5     7  
Functional Ambulation Classification (0-5) [1]
[units: units on a scale]
Mean (Standard Deviation)
  1  (0.8)     0.9  (1)     1  (0.8)  
Time poststroke  
[units: days]
Mean (Standard Deviation)
  52  (42)     45  (30)     52  (31)  
[1] Patients will be rated on the following 6 categories: 0: Patient cannot walk, or needs help from 2 or more persons. 1: Patients needs firm continuous support from 1 person who helps carrying weight and with balance. 2: Patient needs continuous or intermittent support of one person to help with balance and coordination. 3: Patient requires verbal supervision or stand-by help from one person without physical contact. 4: Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces. 5: Patient can walk independently anywhere.



  Outcome Measures

1.  Primary:   Peak Oxygen Uptake (V'O2peak)   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Oliver Stoller
Organization: Bern University of Applied Sciences
phone: +41344264195
e-mail: oliver.stoller@bfh.ch


Publications of Results:
Other Publications:

Responsible Party: Oliver Stoller, Bern University of Applied Sciences
ClinicalTrials.gov Identifier: NCT01679600     History of Changes
Other Study ID Numbers: CardioRobot
Study First Received: August 29, 2012
Results First Received: July 3, 2015
Last Updated: July 30, 2015
Health Authority: Switzerland: Ethikkommission