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Trial record 8 of 16 for:    Foot Drop AND meter

Functional Electrical Stimulation for Footdrop in Hemiparesis

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ClinicalTrials.gov Identifier: NCT00148343
Recruitment Status : Completed
First Posted : September 7, 2005
Results First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Information provided by (Responsible Party):
John Chae, MD, MetroHealth Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stroke
Hemiplegia
Interventions Device: Odstock Dropped-Foot Stimulator (ODFS)
Other: Conventional Standard of Care
Procedure: Traditional Physical Therapy Treatment
Enrollment 110

Recruitment Details Subjects screened over 5-yr study period: 469. Subjects completing informed consent and eligibility eval: 158. Subjects enrolled: 110. Last date of enrollment:10/27/2009. Final date subject study completion: 8/2/2010. All subject screening, enrollment, and study participation took place at an academic medical center.
Pre-assignment Details Enrolled subjects (n=110) were stratified by presence or absence of dorsiflexion, based on clinical exam, prior to randomization into treatment and control groups. No enrolled subjects were excluded from the trial prior to assignment to groups.
Arm/Group Title Peroneal Nerve Stimulation (PNS) Standard of Care (no Device or Ankle Foot Orthosis)
Hide Arm/Group Description The peroneal nerve stimulator used in this study was the Odstock Dropped-Foot Stimulator (ODFS). Conventional Standard of Care was defined as either 1) no device or 2) a custom molded hinged ankle foot orthosis (AFO). Standard of care intervention device was determined based on clinical indication.
Period Title: Overall Study
Started 54 56
Completed 39 45
Not Completed 15 11
Reason Not Completed
Withdrawal by Subject             12             7
Physician Decision             3             4
Arm/Group Title Peroneal Nerve Stimulation Standard of Care Total
Hide Arm/Group Description Odstock Dropped Foot Stimulator No device or ankle foot orthosis Total of all reporting groups
Overall Number of Baseline Participants 54 56 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 56 participants 110 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
47
  87.0%
51
  91.1%
98
  89.1%
>=65 years
7
  13.0%
5
   8.9%
12
  10.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 56 participants 110 participants
52.8  (12.2) 53.2  (10.1) 53.0  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 56 participants 110 participants
Female
24
  44.4%
19
  33.9%
43
  39.1%
Male
30
  55.6%
37
  66.1%
67
  60.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants 56 participants 110 participants
54 56 110
1.Primary Outcome
Title Fugl-Meyer Motor Assessment (FMA)
Hide Description Lower limb motor impairment as measured by the lower limb portion of the Fugl-Meyer Assessment (FMA) which consists of 17 items, with a maximum possible score of 34 points, with lower scores indicating higher impairment. Each item was answered using a 3-point ordinal scale (0 = cannot perform, 1 = can partially perform, 2 = can fully perform).
Time Frame Weeks 0, 12, 24, 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For intent-to-treat analysis, all participants who were randomized and completed baseline assessments were included in the analysis
Arm/Group Title Peroneal Nerve Stimulation Standard of Care
Hide Arm/Group Description:
Odstock Dropped Foot Stimulator
No device or ankle foot orthosis
Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 20.1  (5.9) 20.3  (6.0)
12- weeks 21.5  (6.27) 21.18  (5.72)
24- weeks 21.26  (6.05) 21.17  (5.58)
36 weeks 21.93  (5.84) 21.02  (5.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peroneal Nerve Stimulation, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
-0.2 to 2.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.76
Estimation Comments Mixed model analysis. Slope is in reference to treatment x time interaction for full 36 weeks
2.Secondary Outcome
Title Steps Per Minute
Hide Description The number of steps taken by participants in one minute
Time Frame Weeks 0, 12, 24, 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peroneal Nerve Stimulation Standard of Care
Hide Arm/Group Description:
Odstock Dropped Foot Stimulator
No device or ankle foot orthosis
Overall Number of Participants Analyzed 54 56
Mean (Standard Deviation)
Unit of Measure: Steps/Min
Baseline 65.0  (22) 66.7  (22.7)
12-weeks 67.4  (21.5) 72.6  (22.6)
24-weeks 69.3  (26.35) 72.0  (23.16)
36-weeks 70.84  (26.83) 73.74  (22.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peroneal Nerve Stimulation, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -5.07
Confidence Interval (2-Sided) 95%
-10.05 to -0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.54
Estimation Comments Slope is in reference to from baseline to end of follow-up at 36 weeks.
3.Secondary Outcome
Title Modified Emory Functional Ambulation Profile(mEFAP)
Hide Description The mEFAP comprises 5 individually timed tasks performed over different environmental terrains. The subtasks include (1) a 5-meter walk on a hard floor; (2) a 5-meter walk on a carpeted surface; (3) rising from a chair, a 3-meter walk, and return to a seated position (the “timed up-and-go” test); (4) traversing a standardized obstacle course; and (5) ascending and descending 5 stairs. The mEFAP is performed with or without the use of an orthotic device or an AD. Manual assistance (MA) is provided as necessary. The subject can use rails when climbing the stairs. The 5 timed subscores are added to derive a total score in seconds.
Time Frame Weeks 0, 12, 24, 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peroneal Nerve Stimulation Standard of Care
Hide Arm/Group Description:
Odstock Dropped Foot Stimulator
No device or ankle foot orthosis
Overall Number of Participants Analyzed 54 56
Mean (Standard Deviation)
Unit of Measure: seconds
Baseline 121.54  (86.59) 118.39  (74.10)
12- weeks 107.92  (78.80) 93.47  (73.02)
24-weeks 110.81  (81.89) 97.25  (71.4)
36-weeks 111.81  (83.16) 96.20  (65.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peroneal Nerve Stimulation, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
-14.096 to 14.716
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.35
Estimation Comments Slope is in reference to start of treatment to end of follow up at 36 weeks
4.Secondary Outcome
Title Stroke-Specific Quality of Life Scale (SS-QOL)
Hide Description

The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains: Mobility, Energy, Upper extremity function, Work/productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking, Personality. There are 11 subscales.

Items are rated on a 5-point Likert scale with higher scores indicate better functioning. The overall SS-QOL summary score (summation of all items) is presented here. Scores range from 49-245.

Time Frame Weeks 0, 12, 24, 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peroneal Nerve Stimulation Standard of Care
Hide Arm/Group Description:
Odstock Dropped Foot Stimulator
No device or ankle foot orthosis
Overall Number of Participants Analyzed 54 56
Mean (Standard Deviation)
Unit of Measure: Summary Score
Baseline 179.12  (35.73) 175.30  (40.67)
12-weeks 191.62  (42.39) 185.42  (34.76)
24-weeks 195.66  (38.25) 184.87  (38.88)
36-weeks 190.23  (44.73) 182.95  (39.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peroneal Nerve Stimulation, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -1.95
Confidence Interval (2-Sided) 95%
-12.79 to 8.89
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.53
Estimation Comments Mixed models analysis. Slope refers to baseline to final follow up at 36 weeks
5.Secondary Outcome
Title Gait Speed
Hide Description [Not Specified]
Time Frame baseline, 12, 24 and 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peroneal Nerve Stimulation Standard of Care
Hide Arm/Group Description:
Odstock Dropped Foot Stimulator
No device or ankle foot orthosis
Overall Number of Participants Analyzed 54 56
Mean (Standard Deviation)
Unit of Measure: meters/sec
Baseline 0.35  (0.20) 0.40  (0.24)
12-weeks 0.40  (0.25) 0.47  (0.24)
24-weeks 0.44  (0.28) 0.46  (0.25)
36-weeks 0.44  (0.28) 0.47  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peroneal Nerve Stimulation, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.006
Confidence Interval (2-Sided) 95%
-0.045 to 0.057
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.026
Estimation Comments Slope is in reference to baseline to end of follow-up at 36 weeks
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Peroneal Nerve Stimulation Standard of Care
Hide Arm/Group Description Odstock Dropped Foot Stimulator No device or ankle foot orthosis
All-Cause Mortality
Peroneal Nerve Stimulation Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)      0/56 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Peroneal Nerve Stimulation Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/54 (38.89%)      7/56 (12.50%)    
Cardiac disorders     
Cardiac *  4/54 (7.41%)  4 3/56 (5.36%)  3
Gastrointestinal disorders     
Gastrointestinal *  1/54 (1.85%)  1 0/56 (0.00%)  0
Infections and infestations     
infection *  0/54 (0.00%)  0 1/56 (1.79%)  1
Musculoskeletal and connective tissue disorders     
Muskuloskeletal *  3/54 (5.56%)  3 2/56 (3.57%)  2
Fall *  7/54 (12.96%)  10 2/56 (3.57%)  2
Nervous system disorders     
Neurologic change *  7/54 (12.96%)  8 0/56 (0.00%)  0
Psychiatric disorders     
Psychiatric *  0/54 (0.00%)  0 1/56 (1.79%)  1
Renal and urinary disorders     
Urologic *  1/54 (1.85%)  1 0/56 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Peroneal Nerve Stimulation Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/54 (72.22%)      20/56 (35.71%)    
Endocrine disorders     
Endocrine *  1/54 (1.85%)  1 0/56 (0.00%)  0
Injury, poisoning and procedural complications     
Fall *  25/54 (46.30%)  38 15/56 (26.79%)  24
Musculoskeletal and connective tissue disorders     
Muskuloskeletal *  13/54 (24.07%)  16 4/56 (7.14%)  4
Nervous system disorders     
Neurologic *  2/54 (3.70%)  3 3/56 (5.36%)  3
Skin and subcutaneous tissue disorders     
Skin *  17/54 (31.48%)  21 4/56 (7.14%)  9
*
Indicates events were collected by non-systematic assessment
  1. Uneven randomization with respect to dorsiflexion status and mEFAP at baseline.
  2. High drop out rate of 30% for the ODFS and 20% for usual care
  3. Optimal dose and duration of treatment unknown
  4. Activity monitor on ODFS and AFO not reliable
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lynne Sheffler, MD
Organization: Case Western Reserve University/MetroHealth Medcial Center
Phone: 216-957-3570 ext 73556
Publications:
Taylor P, Burridge J. Functional Electrical Stimulation - the Odstock Dropped Foot Stimulator. In: Sassoon R, ed. Understanding Stroke: Pardoe Blacker Publishing Ltd, 2002:72-78.
Taylor P. The use of electrical stimulation for correction of dropped foot in subjects with upper motor neuron lesions. Advances in Clinical Neurosciences and Rehabilitation 2002; 2:16-18.
Mann GE, Wright PA, Swain ID. Training effects of electrical stimulation and the conventional ankle foot orthosis in the correction of drop foot following stroke., 1st Annual Conference of FESnet, 2002.
Taylor P, Mann G, Swain I. Does prior use of an Ankle Foot Orthosis (AFO) effect the response to use of the Odstock Dropped Foot Stimulator?, Institute of Physics and Engineering in Medicine (IPEM) Annual Scientific Meeting, Bath, U.K., September 15-17, 2003:89-90.
Buurke JH, Roetenberg D, Kleissen RFM, Hermens HJ. Early recovery of gait after stroke, 3rd World Congress in Neurological Rehabilitation, Venice, Italy, April 2-6, 2002, 2002.
El-Hayek K, Quinn A, Berezovskiy R, Santing J, Harley M, Chae J. Relationship between lower limb motor impairment and ambulation function among chronic stroke survivors. Submitted.
International Society for Prosthetics and Orthotics. Consensus Conference on
Stefancic M, Rebersek M, Merletti R. The therapeutic effects of the Ljublijana functional electrical brace. Eur Medicophys 1976; 12:1-9.
Sullivan SB. Stroke. In: Sullivan SB, ed. Physical Rehabilitation: Assessment and Treatment. Philadelphia: F. A. Davis Company, 1994:327-360.
Verbeke G, Molenbergh G. Linear mixed models for longitudinal data. New York: Springer-Verlag, 2000.
Harrell FE. Regression modeling strategies. New York: Springer-Verlag, 2001.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Chae, MD, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00148343     History of Changes
Other Study ID Numbers: IRB04-00104
R01HD044816 ( U.S. NIH Grant/Contract )
First Submitted: September 2, 2005
First Posted: September 7, 2005
Results First Submitted: March 2, 2018
Results First Posted: June 1, 2018
Last Update Posted: June 1, 2018