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Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01029912
First Posted: December 10, 2009
Last Update Posted: November 6, 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.
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Information provided by (Responsible Party):
Jayme Knutson, MetroHealth Medical Center
Results First Submitted: September 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stroke
Hemiparesis
Lower Extremity Paresis
Intervention: Device: Electrical stimulator

  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
CCNMES

Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator)

CCFES Electrical Stimulator: 6-week intervention

Home: Self-administered active repetitive CCNMES-mediated ankle dorsiflexion exercise performed ten 51-minute sessions (three 15-min sets separated by 3-min rest) per week at home.

Lab: 15 minutes of therapist-guided CCFES-mediated ankle exercise + 30 minutes of gait training in the laboratory twice a week.

Cyclic NMES

Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator)

Cyclic NMES Electrical Stimulator: 6-week intervention

Home: Self-administered active repetitive Cyclic NMES-mediated ankle dorsiflexion exercise performed ten 51-minute sessions (three 15-min sets separated by 3-min rest) per week at home.

Lab: 15 minutes of therapist-guided Cyclic NMES-mediated ankle exercise + 30 minutes of gait training in the laboratory twice a week.


Participant Flow:   Overall Study
    CCNMES   Cyclic NMES
STARTED   14   12 
COMPLETED   12   12 
NOT COMPLETED   2   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.
Only participants who completed treatment were analyzed.

Reporting Groups
  Description
CCNMES

Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator)

Electrical stimulator: 6-week intervention

15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.

Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device.

Cyclic NMES

Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator)

Electrical stimulator: 6-week intervention

15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.

Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device.

Total Total of all reporting groups

Baseline Measures
   CCNMES   Cyclic NMES   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.7  (13.7)   59.3  (9.1)   58.0  (11.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  33.3%      6  50.0%      10  41.7% 
Male      8  66.7%      6  50.0%      14  58.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      6  50.0%      5  41.7%      11  45.8% 
White      6  50.0%      7  58.3%      13  54.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Years Since Stroke 
[Units: Years]
Mean (Standard Deviation)
 2.7  (1.8)   3.6  (3.9)   3.1  (3.0) 
Lower Extremity Fugl-Meyer Score 
[Units: Units on a scale]
Mean (Standard Deviation)
 19.1  (6.8)   18.9  (7.0)   19.0  (6.8) 
Time to complete Modified Emory Functional Ambulation Profile (MEFAP) in seconds 
[Units: Seconds]
Mean (Standard Deviation)
 120.7  (86.3)   118.6  (86.5)   119.7  (84.5) 
Gait velocity (cm/sec) 
[Units: Cm/sec]
Mean (Standard Deviation)
 39.9  (22.3)   38.3  (19.1)   39.1  (20.4) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Lower Extremity Fugl-Meyer Score at End of Treatment   [ Time Frame: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks. ]

2.  Primary:   Change in Gait Velocity (cm/Sec) at End of Treatment   [ Time Frame: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks. ]

3.  Primary:   Change in Time (Sec) to Complete the Modified Emory Functional Ambulation Profile (MEFAP).   [ Time Frame: 2 timepoints: Prior to treatment, and End of treatment at 6 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. Jayme Knutson
Organization: MetroHealth Medical Center
phone: 2167787342 ext 216
e-mail: jsk12@case.edu


Publications:


Responsible Party: Jayme Knutson, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01029912     History of Changes
Other Study ID Numbers: R21HD061593 ( U.S. NIH Grant/Contract )
First Submitted: December 9, 2009
First Posted: December 10, 2009
Results First Submitted: September 8, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017