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Cross-Education Of Contralateral Antagonists

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ILHAN KARACAN, Vakif Gureba Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01103232
First received: April 12, 2010
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
Results First Received: August 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Muscle Strength Quantitative Trait Locus 1
Interventions: Procedure: Experimental group
Procedure: Control group

  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
All cases were recruited within 6 weeks in the VGEAH PMR Clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Experimental Electrical muscle stimulation of the right wrist flexor muscles was applied
Control Transcutaneous electrical nerve stimulation was applied

Participant Flow:   Overall Study
    Experimental     Control  
STARTED     13     13  
COMPLETED     12     11  
NOT COMPLETED     1     2  
Withdrawal by Subject                 1                 1  
Protocol Violation                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Experimental Electrical muscle stimulation of the right wrist flexor muscles was applied
Control Transcutaneous electrical nerve stimulation was applied
Total Total of all reporting groups

Baseline Measures
    Experimental     Control     Total  
Number of Participants  
[units: participants]
 		  13     13     26  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     13     13     26  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  29.6  ± 5.7     34.2  ± 4.8     32  ± 5.3  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     13     13     26  
Muscle strength  
[units: Newton meters]
Mean ± Standard Deviation 		  44.1  ± 12.0     11.7  ± 6.3     33.2  ± 11.9  



  Outcome Measures

1.  Primary:   Changes in Muscle Strength in the Contralateral Untrained Wrist Muscles   [ Time Frame: 6 weeks (The change calculated as 6 months minus baseline) ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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Time Frame 8 weeks
Additional Description 8 weeks

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Experimental Electrical muscle stimulation of the right wrist flexor muscles was applied
Control Transcutaneous electrical nerve stimulation was applied

Other Adverse Events
    Experimental     Control  
Total, other (not including serious) adverse events      
# participants affected / at risk     0/13     0/13  



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
This study has small sample size.  


Results Point of Contact:  
Name/Title: ILHAN KARACAN
Organization: Vakif Gureba Training and Research Hospital
phone: + 90 212 4531700
e-mail: ilhankaracan@hotmail.com


No publications provided by Vakif Gureba Training and Research Hospital

Publications automatically indexed to this study:


Responsible Party: ILHAN KARACAN, Vakif Gureba Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01103232     History of Changes
Other Study ID Numbers: VGEAH FTR
Study First Received: April 12, 2010
Results First Received: August 13, 2011
Last Updated: June 20, 2012
Health Authority: Turkey: Ministry of Health