Trial Outcomes & Findings for Functional Electrical Stimulation (FES) Driven Stepping in Individuals With Spinal Cord Injury (NCT NCT01479777)

Results Overview

Change in motor, pin prick, and light touch score components of the ASIA Impairment scale (AIS) after 8 weeks of stepping FES in persons with spinal cord injury. The AIS evaluates motor and sensory function and comprises motor (min 0, max 100), pin prick (min 0, max 112), and light touch (min 0, max 112) scores. Higher scores represent better functional outcome. AIS Classificatrion: A = Complete: No motor or sensory function is preserved in the sacral segments S4-S5. B = Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5. C = Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3. D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more. E = Normal: motor and sensory function are normal.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Baseline, 8 weeks

Results posted on

2014-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	FES Stepping For the next 8 weeks, we will ask you to come to the ICSCI twice (2) time per week during which you will perform FES Stepping.
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	FES Stepping For the next 8 weeks, we will ask you to come to the ICSCI twice (2) time per week during which you will perform FES Stepping.
Overall Study Physician Decision	2

Baseline Characteristics

Functional Electrical Stimulation (FES) Driven Stepping in Individuals With Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FES Stepping n=12 Participants FES Stepping, twice a week, for 8 weeks.
Age, Continuous	37 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 8 weeks

Change in motor, pin prick, and light touch score components of the ASIA Impairment scale (AIS) after 8 weeks of stepping FES in persons with spinal cord injury. The AIS evaluates motor and sensory function and comprises motor (min 0, max 100), pin prick (min 0, max 112), and light touch (min 0, max 112) scores. Higher scores represent better functional outcome. AIS Classificatrion: A = Complete: No motor or sensory function is preserved in the sacral segments S4-S5. B = Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5. C = Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3. D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more. E = Normal: motor and sensory function are normal.

Outcome measures

Outcome measures
Measure	FES Stepping n=10 Participants FES Stepping, twice a week, for 8 weeks.
Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) Upper Extremity Motor Score	1.0 scores on AIS Scale Interval 0.0 to 5.0
Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) Lower Extremity Motor Score	2.7 scores on AIS Scale Interval -1.0 to 7.0
Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) Light Touch	2.4 scores on AIS Scale Interval -2.0 to 9.0
Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) Pin prick	-1.2 scores on AIS Scale Interval -16.0 to 11.0

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters.

Outcome measures

Outcome measures
Measure	FES Stepping n=10 Participants FES Stepping, twice a week, for 8 weeks.
Change in Heart Rate	-3.3 beats per minute Interval -18.0 to 6.0

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters.

Outcome measures

Outcome measures
Measure	FES Stepping n=10 Participants FES Stepping, twice a week, for 8 weeks.
Change in Systolic Blood Pressure	1.1 mmHg Interval -24.0 to 23.0

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters.

Outcome measures

Outcome measures
Measure	FES Stepping n=10 Participants FES Stepping, twice a week, for 8 weeks.
Change in Diastolic Plood Pressure	1.8 mmHg Interval -14.0 to 22.0

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Change in rate of perceived exertion (RPE) following 8 weeks of FES. Change in rate of perceived exertion (RPE) from baseline was computed from week 8 parameters. The RPE scale is a 15 point scale ranging from 6 to 20 points. Higher scores indicate greater exertion.

Outcome measures

Outcome measures
Measure	FES Stepping n=10 Participants FES Stepping, twice a week, for 8 weeks.
Change in Rate of Perceived Exertion	-0.64 scores on RPE scale Interval -3.0 to 1.0

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters.

Outcome measures

Outcome measures
Measure	FES Stepping n=10 Participants FES Stepping, twice a week, for 8 weeks.
Change in Vital Capacity	-0.29 litres Interval -0.97 to 0.56

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters.

Outcome measures

Outcome measures
Measure	FES Stepping n=10 Participants FES Stepping, twice a week, for 8 weeks.
Change in Peak Cough Flow	-6 liters/minute Interval -110.0 to 100.0

Adverse Events

FES Stepping

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FES Stepping n=12 participants at risk FES Stepping, twice a week, for 8 weeks.
Musculoskeletal and connective tissue disorders Ankle Swelling (X-ray negative for bone fracture or dislocation)	16.7% 2/12 • Number of events 2
Cardiac disorders Lightheadedness	25.0% 3/12 • Number of events 3
Musculoskeletal and connective tissue disorders Increased tone in lower extremity	25.0% 3/12 • Number of events 3

Additional Information

Dr. Cristina Sadowsky

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Phone: 443-923-9210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place