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Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00125619
First Posted: August 1, 2005
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: April 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Stroke
Intervention: Behavioral: Locomotor training

  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
Arm 2: Robot-assisted

Rehabilitation got Post-stroke Hemiparesis

Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support).

Arm 1: Therapist Assisted Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)

Participant Flow:   Overall Study
    Arm 2: Robot-assisted   Arm 1: Therapist Assisted
STARTED   8   8 
COMPLETED   8   8 
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
Arm 2: Robot-assisted

Rehabilitation for Post-stroke Hemiparesis

Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support).

Arm 1: Therapist Assisted Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
Total Total of all reporting groups

Baseline Measures
   Arm 2: Robot-assisted   Arm 1: Therapist Assisted   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   8   16 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6  75.0%      6  75.0%      12  75.0% 
>=65 years      2  25.0%      2  25.0%      4  25.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.6  (16.9)   55.1  (13.6)   56.8  (14.4) 
Gender 
[Units: Participants]
Count of Participants
     
Female      2  25.0%      1  12.5%      3  18.8% 
Male      6  75.0%      7  87.5%      13  81.3% 
Region of Enrollment 
[Units: Participants]
     
United States   8   8   16 
Self-selected Overground Walking speed 
[Units: Meters per second]
Mean (Standard Deviation)
 0.62  (0.31)   0.62  (0.28)   0.62  (0.28) 
Fast Walking Speed 
[Units: Meters per second]
Mean (Standard Deviation)
 0.87  (0.55)   0.72  (0.37)   0.80  (0.47) 
Six Minute Walk Test 
[Units: Distance walked, meters]
Mean (Standard Deviation)
 267.3  (187.2)   234.3  (141.2)   250.8  (161.1) 
Step-length Asymmetry [1] 
[Units: Ratio]
Mean (Standard Deviation)
 0.53  (0.58)   0.39  (0.37)   0.45  (0.48) 
[1]

Measure is a ratio of paretic/non-paretic step length calculated as follows:

= ABS[1-(paretic step length/non-paretic step length)]

Values approaching 0 reveal greater symmetry.

Lower Extremity Fugl-Meyer Motor Assessment [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 23.0  (4.3)   21.4  (5.1)   23  (4.5) 
[1] The Fugl-Meyer Motor Assessment is a standardized clinical assessment used to determine the magnitude of motor impairment (or severity) following stroke. There are separate scales for the upper and lower extremities. Here we used the lower extremity component which has a range of 36 points. Higher scores reflect better motor status than lower scores. Importantly, there is a remarkable ceiling effect with the FMA, thus a full score of 36 points does not indicate an individual post-stroke has fully recovered.
Short Physical Performance Battery [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.9  (3.4)   7.8  (3.0)   7.31  (3.1) 
[1] The Short Physical Performance Battery measures 3 components of physical function: walking speed, strength - assessed through repeated sit-to-stand movements, and balance. The SPPB is scored over a range of 0-12 points, where 12 is the highest, or best, score. Each of the 3 components contributes 4 points to the total SPPB, although sub-scores are not typically calculated and/or interpreted.
Berg Balance Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 46.9  (7.5)   47  (7.0)   46.9  (7.0) 
[1] The Berg Balance Scale is a standardized clinical assessment of balance function involving performance of 14 tasks ranging from sitting unsupported to standing on one leg with eyes closed. It is scored on a range of 0 - 56 points where 56 is the best score, which is generally equivalent to normal.


  Outcome Measures
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1.  Primary:   Self-selected Overground Walking Speed   [ Time Frame: 4 weeks (s/p 12 sessions of locomotor training) ]

2.  Secondary:   Fast Walking Speed   [ Time Frame: 4 weeks (s/p 12 training sessions) ]

3.  Secondary:   Six Minute Walk   [ Time Frame: 4 weeks ]

4.  Secondary:   Step Length Ratio (Abs)   [ Time Frame: 4 weeks ]

5.  Secondary:   Lower Extremity Fugl-Meyer Motor Assessment   [ Time Frame: 4 weeks ]

6.  Secondary:   Short Physical Performance Battery   [ Time Frame: 4 weeks ]

7.  Secondary:   Berg Balance Scale   [ 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
Small sample size, but consistent with intent of pilot study Inclusion criterion was >6 months post-event, allowing for large heterogeneity in chronicity Intervention was limited (12 sessions distributed over 4 weeks)


  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. Carolynn Patten
Organization: VA Brain Rehabilitation Research Center
phone: 352.376.1611 ext 4160
e-mail: patten@phhp.ufl.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00125619     History of Changes
Other Study ID Numbers: B4032-I
First Submitted: July 28, 2005
First Posted: August 1, 2005
Results First Submitted: April 17, 2015
Results First Posted: February 17, 2017
Last Update Posted: February 17, 2017