Trial Outcomes & Findings for Stroke Gait Rehabilitation Using Functional Electrical Stimulation (NCT NCT01668602)

Results Overview

Change from baseline in MEP amplitude (transverse abdominal (TA) muscle) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)

Results posted on

2021-03-10

Participant Flow

Enrollment began in August 2013 and all study follow up was completed on May 1, 2019.

Participant milestones

Participant milestones
Measure	Cohort 1 - FastFES Training Participants with chronic stroke in Cohort 1 will receive 18 training sessions of fast walking on a treadmill plus Functional Electrical Stimulation (FastFES).	Cohort 2 - FastFES and Fast Walking Participants with chronic stroke in Cohort 2 who complete 3 sessions of FastFES and 3 sessions of fast walking on a treadmill.
Overall Study STARTED	2	22
Overall Study Cohort 2 - Began FastFES Sessions	0	20
Overall Study Cohort 2 - Completed 3 Sessions of FastFES	0	19
Overall Study Cohort 2 - Began Fast Walking Sessions	0	20
Overall Study Cohort 2 - Completed 3 Sessions of Fast Walking	0	18
Overall Study COMPLETED	2	18
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 - FastFES Training n=2 Participants Participants in Cohort 1 will receive 18 training sessions of FastFES (fast treadmill walking with electrical stimulation).	Cohort 2 - FastFES and Fast Walking n=22 Participants Participants in Cohort 2 who complete 3 sessions of FastFES and 3 sessions of fast walking.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=2 Participants	0 Participants n=22 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=2 Participants	12 Participants n=22 Participants	13 Participants n=24 Participants
Age, Categorical >=65 years	1 Participants n=2 Participants	10 Participants n=22 Participants	11 Participants n=24 Participants
Sex: Female, Male Female	2 Participants n=2 Participants	10 Participants n=22 Participants	12 Participants n=24 Participants
Sex: Female, Male Male	0 Participants n=2 Participants	12 Participants n=22 Participants	12 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	2 Participants n=2 Participants	22 Participants n=22 Participants	24 Participants n=24 Participants

PRIMARY outcome

Timeframe: Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)

Population: This analysis includes participants in Cohort 2 who had complete data for this assessment. There were issues with data collection during the training sessions and stimulus artifact causing noise in data, resulting in incomplete data for some participants.

Change from baseline in MEP amplitude (transverse abdominal (TA) muscle) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.

Outcome measures

Outcome measures
Measure	Three Sessions of FastFES n=12 Participants Cohort 2 participants after having three sessions of FastFES	Three Sessions of Fast Walking n=12 Participants Cohort 2 participants after having three sessions of Fast Walking
Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2	0.058 mV Standard Deviation 0.110	0.013 mV Standard Deviation 0.200

PRIMARY outcome

Timeframe: Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)

Population: This analysis includes participants in Cohort 2 who have complete data for this assessment. There were issues with data collection during the training sessions and stimulus artifact causing noise in data, resulting in incomplete data for some participants.

Change from baseline in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation. Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa. The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle. Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.

Outcome measures

Outcome measures
Measure	Three Sessions of FastFES n=12 Participants Cohort 2 participants after having three sessions of FastFES	Three Sessions of Fast Walking n=12 Participants Cohort 2 participants after having three sessions of Fast Walking
Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2	4.14 percentage of Hmax/Mmax Standard Deviation 0.05	0.44 percentage of Hmax/Mmax Standard Deviation 0.09

PRIMARY outcome

Timeframe: Baseline and up to 6 weeks

Population: This analysis includes participants in Cohort 1.

Change from baseline in MEP amplitude (TA muscle in a resting state) is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.

Outcome measures

Outcome measures
Measure	Three Sessions of FastFES n=2 Participants Cohort 2 participants after having three sessions of FastFES	Three Sessions of Fast Walking Cohort 2 participants after having three sessions of Fast Walking
Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES After 18 Training Sessions in Cohort 1	-0.02 mV Standard Deviation 0.07	—

PRIMARY outcome

Timeframe: Baseline and up to 6 weeks

Population: This analysis includes participants from Cohort 1.

Change from baseline in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation. Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa. The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle. Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.

Outcome measures

Outcome measures
Measure	Three Sessions of FastFES n=2 Participants Cohort 2 participants after having three sessions of FastFES	Three Sessions of Fast Walking Cohort 2 participants after having three sessions of Fast Walking
Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1	24.49 percentage of Hmax/Mmax Standard Deviation 45.88	—

SECONDARY outcome

Timeframe: Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)

Population: This analysis includes participants from Cohort 2 who had complete data for this assessment. There were issues with data collection during the training sessions and stimulus artifact causing noise in data, resulting in incomplete data for some participants.

Change from baseline in peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt. Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.

Outcome measures

Outcome measures
Measure	Three Sessions of FastFES n=12 Participants Cohort 2 participants after having three sessions of FastFES	Three Sessions of Fast Walking n=12 Participants Cohort 2 participants after having three sessions of Fast Walking
Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2	8.68 Newtons.milliseconds (N.ms) Standard Deviation 11.76	-2.00 Newtons.milliseconds (N.ms) Standard Deviation 12.76

SECONDARY outcome

Timeframe: Baseline and up to 6 weeks

Population: This analysis includes participants in Cohort 1.

Change from baseline in peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt. Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.

Outcome measures

Outcome measures
Measure	Three Sessions of FastFES n=2 Participants Cohort 2 participants after having three sessions of FastFES	Three Sessions of Fast Walking Cohort 2 participants after having three sessions of Fast Walking
Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1	15.40 Newtons.milliseconds (N.ms) Standard Deviation 10.82	—

Adverse Events

Cohort 1 - 18 Sessions of FastFES Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2 - Three Sessions of FastFES

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2 - Three Sessions of Fast Walking

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1 - 18 Sessions of FastFES Training n=2 participants at risk Participants in Cohort 1 will receive 18 training sessions of FastFES (fast treadmill walking with electrical stimulation).	Cohort 2 - Three Sessions of FastFES n=20 participants at risk Participants in Cohort 2 during training sessions of FastFES.	Cohort 2 - Three Sessions of Fast Walking n=20 participants at risk；n=19 participants at risk Participants in Cohort 2 during training sessions of Fast Walking.
General disorders Lightheadedness during H-reflex evaluation	0.00% 0/2 • Adverse events were collected during the training sessions, from the start of the study intervention session through the last session (up to 6 weeks). In Cohort 2 there were 20 participants who received at least one session of FastFES and 19 who received at least one session of Fast Walking.	0.00% 0/20 • Adverse events were collected during the training sessions, from the start of the study intervention session through the last session (up to 6 weeks). In Cohort 2 there were 20 participants who received at least one session of FastFES and 19 who received at least one session of Fast Walking.	5.0% 1/20 • Adverse events were collected during the training sessions, from the start of the study intervention session through the last session (up to 6 weeks). In Cohort 2 there were 20 participants who received at least one session of FastFES and 19 who received at least one session of Fast Walking.

Additional Information

Trisha Kesar, PT, PhD

Emory University

Phone: 404-712-5803

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place