Trial Outcomes & Findings for Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors (NCT NCT01029912)
NCT ID: NCT01029912
Last Updated: 2017-12-07
Results Overview
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.
COMPLETED
NA
26 participants
2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
2017-12-07
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors
Baseline characteristics by cohort
| Measure |
CCNMES
n=12 Participants
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
n=12 Participants
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
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
58.0 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Years Since Stroke
|
2.7 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
3.6 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
3.1 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Lower Extremity Fugl-Meyer Score
|
19.1 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
18.9 units on a scale
STANDARD_DEVIATION 7.0 • n=7 Participants
|
19.0 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Time to complete Modified Emory Functional Ambulation Profile (MEFAP) in seconds
|
120.7 seconds
STANDARD_DEVIATION 86.3 • n=5 Participants
|
118.6 seconds
STANDARD_DEVIATION 86.5 • n=7 Participants
|
119.7 seconds
STANDARD_DEVIATION 84.5 • n=5 Participants
|
|
Gait velocity (cm/sec)
|
39.9 cm/sec
STANDARD_DEVIATION 22.3 • n=5 Participants
|
38.3 cm/sec
STANDARD_DEVIATION 19.1 • n=7 Participants
|
39.1 cm/sec
STANDARD_DEVIATION 20.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.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.
Outcome measures
| Measure |
CCNMES
n=12 Participants
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
n=12 Participants
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.
|
|---|---|---|
|
Change in Lower Extremity Fugl-Meyer Score at End of Treatment
|
0.93 units on a scale
Standard Error 0.65
|
1.8 units on a scale
Standard Error 0.77
|
PRIMARY outcome
Timeframe: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.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.
Outcome measures
| Measure |
CCNMES
n=12 Participants
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
n=12 Participants
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.
|
|---|---|---|
|
Change in Gait Velocity (cm/Sec) at End of Treatment
|
3.0 cm/sec
Standard Error 2.1
|
1.2 cm/sec
Standard Error 2.6
|
PRIMARY outcome
Timeframe: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks.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.
Outcome measures
| Measure |
CCNMES
n=12 Participants
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
n=12 Participants
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.
|
|---|---|---|
|
Change in Time (Sec) to Complete the Modified Emory Functional Ambulation Profile (MEFAP).
|
-9.6 seconds
Standard Error 2.6
|
-3.2 seconds
Standard Error 4.1
|
Adverse Events
CCNMES
Cyclic NMES
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CCNMES
n=12 participants at risk
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
n=12 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Discomfort from stimulation
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place