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

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ClinicalTrials.gov Identifier: NCT01479777
Recruitment Status : Completed
First Posted : November 24, 2011
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
Cristina Sadowsky, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Spinal Cord Injury
Intervention Device: FES Stepping (RT600 from Restorative Therapies, INC.)
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FES Stepping
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 12
Completed 10
Not Completed 2
Reason Not Completed
Physician Decision             2
Arm/Group Title FES Stepping
Hide Arm/Group Description FES Stepping, twice a week, for 8 weeks.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
37  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
1.Primary Outcome
Title Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)
Hide Description

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.

Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FES Stepping
Hide Arm/Group Description:
FES Stepping, twice a week, for 8 weeks.
Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: scores on AIS Scale
Upper Extremity Motor Score
1.0
(0 to 5)
Lower Extremity Motor Score
2.7
(-1.0 to 7)
Light Touch
2.4
(-2.0 to 9)
Pin prick
-1.2
(-16.0 to 11.0)
2.Secondary Outcome
Title Change in Heart Rate
Hide Description Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FES Stepping
Hide Arm/Group Description:
FES Stepping, twice a week, for 8 weeks.
Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: beats per minute
-3.3
(-18 to 6)
3.Secondary Outcome
Title Change in Systolic Blood Pressure
Hide Description Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FES Stepping
Hide Arm/Group Description:
FES Stepping, twice a week, for 8 weeks.
Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: mmHg
1.1
(-24 to 23)
4.Secondary Outcome
Title Change in Diastolic Plood Pressure
Hide Description Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FES Stepping
Hide Arm/Group Description:
FES Stepping, twice a week, for 8 weeks.
Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: mmHg
1.8
(-14 to 22)
5.Secondary Outcome
Title Change in Rate of Perceived Exertion
Hide Description

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.

Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FES Stepping
Hide Arm/Group Description:
FES Stepping, twice a week, for 8 weeks.
Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: scores on RPE scale
-0.64
(-3.0 to 1.0)
6.Secondary Outcome
Title Change in Vital Capacity
Hide Description Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FES Stepping
Hide Arm/Group Description:
FES Stepping, twice a week, for 8 weeks.
Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: litres
-0.29
(-0.97 to 0.56)
7.Secondary Outcome
Title Change in Peak Cough Flow
Hide Description Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FES Stepping
Hide Arm/Group Description:
FES Stepping, twice a week, for 8 weeks.
Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: liters/minute
-6
(-110 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FES Stepping
Hide Arm/Group Description FES Stepping, twice a week, for 8 weeks.
All-Cause Mortality
FES Stepping
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
FES Stepping
Affected / at Risk (%) # Events
Total   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 0%
FES Stepping
Affected / at Risk (%) # Events
Total   6/12 (50.00%)    
Cardiac disorders   
Lightheadedness * [1]  3/12 (25.00%)  3
Musculoskeletal and connective tissue disorders   
Ankle Swelling (X-ray negative for bone fracture or dislocation) * [2]  2/12 (16.67%)  2
Increased tone in lower extremity * [3]  3/12 (25.00%)  3
*
Indicates events were collected by non-systematic assessment
[1]
FES was stopped. participant rested, and symptoms resolved. Did not affect continued participation in study
[2]
Reported swelling and bruise on medial aspect of ankle X-ray negative for bone fracture, dislocation Resume FES stepping by taking precautions by giving ankles more support: ace bandage wrapping; wear ankle supportive running shoes (high tops)
[3]
Increased tone did not interfere with FES stepping
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Cristina Sadowsky
Organization: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Phone: 443-923-9210
Responsible Party: Cristina Sadowsky, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01479777     History of Changes
Other Study ID Numbers: NA_00016421
First Submitted: November 15, 2011
First Posted: November 24, 2011
Results First Submitted: August 1, 2013
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014