An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chua Sui Geok, Karen, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT01811680
First received: March 5, 2013
Last updated: January 2, 2015
Last verified: January 2015
Results First Received: September 12, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Stroke
Hemiplegic Gait
Intervention: Device: Variable Speed and Sensing Treadmill

  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
No text entered.

Reporting Groups
  Description
Supervised Treadmill Training

Supervised treadmill training on variable sensing treadmill.

Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training.


Participant Flow:   Overall Study
    Supervised Treadmill Training  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     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.
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Reporting Groups
  Description
Supervised Treadmill Training

Supervised treadmill training on variable sensing treadmill.

Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training.


Baseline Measures
    Supervised Treadmill Training  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Mean (Standard Deviation)
  55.5  (9.85)  
Age  
[units: number¬†of¬†participants]
 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     1  
Gender  
[units: participants]
 
Female     2  
Male     8  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     10  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     0  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
Singapore     10  



  Outcome Measures
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1.  Primary:   6 Minute Walk Test (Metres)   [ Time Frame: 8 weeks ]

2.  Primary:   10 Meter Walk Test   [ Time Frame: 8 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
There were technical limitations due to Gaitrite walkway malfunction midway in the trial leading to unreliable cadence results. Step length results were not affected.


  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.


Results Point of Contact:  
Name/Title: Dr Karen Chua
Organization: Tan Tock Seng Hospital
phone: 65 68894580
e-mail: karen_chua@ttsh.com.sg


No publications provided


Responsible Party: Chua Sui Geok, Karen, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT01811680     History of Changes
Other Study ID Numbers: NHG DSRB_D_2012/00571
Study First Received: March 5, 2013
Results First Received: September 12, 2014
Last Updated: January 2, 2015
Health Authority: Singapore: Domain Specific Review Boards