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Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors

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ClinicalTrials.gov Identifier: NCT01029912
Recruitment Status : Completed
First Posted : December 10, 2009
Results First Posted : November 6, 2017
Last Update Posted : December 7, 2017
Sponsor:
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

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

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

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 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 19.1  (6.8)   18.9  (7.0)   19.0  (6.8) 
[1] The Lower Extremity Fugl-Meyer (LEFM) Assessment measures lower limb motor impairment. Participants are asked to attempt to perform isolated and simultaneous movements of the hip, knee, and ankle. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully). These subscores are summed to provide a maximum score of 34, minimum score of 0. Higher scores are considered to be a better outcome.
Time to complete Modified Emory Functional Ambulation Profile (MEFAP) in seconds [1] 
[Units: Seconds]
Mean (Standard Deviation)
 120.7  (86.3)   118.6  (86.5)   119.7  (84.5) 
[1] The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time. Lower times are considered to be a better outcome.
Gait velocity (cm/sec) [1] 
[Units: Cm/sec]
Mean (Standard Deviation)
 39.9  (22.3)   38.3  (19.1)   39.1  (20.4) 
[1] Gait velocity was assessed using a motion capture and analysis system which collected spatio-temporal data as the participant walked 5-meters 10 times at a self-selected comfortable speed within the field of view of the motion capture system. A higher gait velocity is considered to be a better outcome.


  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

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
No text entered.


  More Information

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: December 7, 2017