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Trial record 14 of 16 for:    Foot Drop AND meter

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
Enrollment 26

Recruitment Details  
Pre-assignment Details  
Arm/Group Title CCNMES Cyclic NMES
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 14 12
Completed 12 12
Not Completed 2 0
Arm/Group Title CCNMES Cyclic NMES Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
Only participants who completed treatment were analyzed.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
56.7  (13.7) 59.3  (9.1) 58.0  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
4
  33.3%
6
  50.0%
10
  41.7%
Male
8
  66.7%
6
  50.0%
14
  58.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
2.7  (1.8) 3.6  (3.9) 3.1  (3.0)
Lower Extremity Fugl-Meyer Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants 12 participants 24 participants
19.1  (6.8) 18.9  (7.0) 19.0  (6.8)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 12 participants 12 participants 24 participants
120.7  (86.3) 118.6  (86.5) 119.7  (84.5)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Cm/sec
Number Analyzed 12 participants 12 participants 24 participants
39.9  (22.3) 38.3  (19.1) 39.1  (20.4)
[1]
Measure Description: 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.
1.Primary Outcome
Title Change in Lower Extremity Fugl-Meyer Score at End of Treatment
Hide Description

The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0.

Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged.

Time Frame 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CCNMES Cyclic NMES
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: units on a scale
0.93  (0.65) 1.8  (0.77)
2.Primary Outcome
Title Change in Gait Velocity (cm/Sec) at End of Treatment
Hide Description 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. For each individual, the gait velocity prior to treatment was subtracted from the gait velocity at end of the 6-week treatment. Then for each treatment group, these change values were averaged.
Time Frame 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CCNMES Cyclic NMES
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: cm/sec
3.0  (2.1) 1.2  (2.6)
3.Primary Outcome
Title Change in Time (Sec) to Complete the Modified Emory Functional Ambulation Profile (MEFAP).
Hide Description

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.

For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged.

Time Frame 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CCNMES Cyclic NMES
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: seconds
-9.6  (2.6) -3.2  (4.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CCNMES Cyclic NMES
Hide Arm/Group Description

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 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.

All-Cause Mortality
CCNMES Cyclic NMES
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CCNMES Cyclic NMES
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CCNMES Cyclic NMES
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      1/12 (8.33%)    
Musculoskeletal and connective tissue disorders     
Discomfort from stimulation   1/12 (8.33%)  1 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
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
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 )
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