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Trial record 4 of 16 for:    Foot Drop AND meter

Clinical Study to Evaluate the Implantation of the ActiGait Drop Foot Stimulator System

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ClinicalTrials.gov Identifier: NCT01116466
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : November 17, 2014
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
Otto Bock Healthcare Products GmbH

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stroke
Hemiplegia
Intervention Device: ActiGait
Enrollment 5

Recruitment Details  
Pre-assignment Details  
Arm/Group Title ActiGait - Implantable Drop Foot Stimulator
Hide Arm/Group Description Subjects came with conventional walking aid and then received ActiGait implant
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title ActiGait - Implantable Drop Foot Stimulator
Hide Arm/Group Description Subjects came with conventional walking aid and then received ActiGait implant
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  80.0%
>=65 years
1
  20.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
47.2  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 5 participants
5
1.Primary Outcome
Title Distance Walked in 6 Minutes
Hide Description The test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity (endurance). At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.
Time Frame Baseline, 6 and 12 weeks post-implantation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiGait - Implantable Drop Foot Stimulator
Hide Arm/Group Description:
Subjects came with conventional walking aid and then received ActiGait implant
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: m
Baseline 211  (36.78)
6 weeks post-implantation stimulation off 211  (37.48)
6 weeks post-implantation stimulation on 260  (31.5)
12 weeks post-implantation stimulation off 214  (33.46)
12 weeks post-implantation stimulation on 248  (29.56)
2.Secondary Outcome
Title Walking Speed During 10 Meter Gait Test
Hide Description The test assesses walking speed in meters per second over a short duration. At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.
Time Frame Baseline, 6 and 12 weeks post-implantation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiGait - Implantable Drop Foot Stimulator
Hide Arm/Group Description:
Subjects came with conventional walking aid and then received ActiGait implant
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: m/s
Baseline 0.62  (0.07)
6 weeks post-implantation stimulation off 0.55  (0.065)
6 weeks post-implantation stimulation on 0.77  (0.077)
12 weeks post-implantation stimulation off 0.55  (0.071)
12 weeks post-implantation stimulation on 0.77  (0.064)
3.Secondary Outcome
Title Canadian Occupational Performance Measure (COPM) Score
Hide Description A semi-structured interview is conducted in order to identify subject's limitations with daily occupations of importance in categories self-care, productivtiy or leisure. The subject is then asked to rate the imporance of each of the occupations using a 10-point rating scale. Afterwards the subject chooses up to 5 of the most important occupations (problems) (basis for identifying intervention goals). The subject is asked to use a 10 point scale to rate level of performance and satisfaction with performance for each of the five identified problems. Average COPM performance score and satisfaction score are calculated. The scores range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction.
Time Frame Baseline,12 weeks post-implantation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects were not available for the test.
Arm/Group Title ActiGait - Implantable Drop Foot Stimulator
Hide Arm/Group Description:
Subjects came with conventional walking aid and then received ActiGait implant
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
Performance Baseline 3.37  (1.27)
Performance 12 weeks post-implantation 3.80  (1.74)
Satisfaction Baseline 2.47  (0.46)
Satisfaction 12 weeks post-implantation 2.70  (0.70)
4.Secondary Outcome
Title Four Square Step Test (FSST)
Hide Description It is a test of dynamic balance that clinically assesses the person's ability to step over objects forward, sideways, and backwards. The patient's time to perform the test is measured which shorter time representing better performance. At baseline this test was done with subject's conventional walking aid. At 12 weeks post-implantation it was done with and without stimulation.
Time Frame Baseline, week 12 post-implantation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiGait - Implantable Drop Foot Stimulator
Hide Arm/Group Description:
Subjects came with conventional walking aid and then received ActiGait implant
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: s
Baseline 38.09  (27.41)
12 weeks post-implantation stimulation off 44.44  (39.51)
12 weeks post-implantation stimulation on 21.49  (5.54)
5.Secondary Outcome
Title Nerve Conduction Velocity of the Peroneal Nerve
Hide Description Measured: Nervus peroneus communis (CPN) and Nervus peroneus superficialis (SPN)
Time Frame Baseline, week 12 post-implantation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects were unavailable for the test.
Arm/Group Title ActiGait - Implantable Drop Foot Stimulator
Hide Arm/Group Description:
Subjects came with conventional walking aid and then received ActiGait implant
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: m/s
Baseline CPN 48.33  (4.73)
Baseline SPN 43  (1)
12 weeks post-implantation CPM 50  (4.36)
12 weeks post-implantation SPN 42.67  (6.66)
6.Secondary Outcome
Title Change in MRI of Affected Leg and Implant Post-implantation
Hide Description MRI will be conducted to evaluate the impact of the implant on the common peroneal nerve (e.g. positioning of the nerve cuff along the nerve, path of the lead wire and the common peroneal nerve, estimation of the cross-sectional area of the common peroneal nerve compared to the pre-operative MRI recording, etc.)
Time Frame Week 3 post-implantation
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ActiGait - Implantable Drop Foot Stimulator
Hide Arm/Group Description Subjects came with conventional walking aid and then received ActiGait implant
All-Cause Mortality
ActiGait - Implantable Drop Foot Stimulator
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ActiGait - Implantable Drop Foot Stimulator
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
Surgical and medical procedures   
Haematoma around implantation site and bleeding after stitches removal, requiring additional surgery *  1/5 (20.00%)  1
*
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%
ActiGait - Implantable Drop Foot Stimulator
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
Surgical and medical procedures   
Post-surgical lymphoedema around proximal incision *  1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
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: Medical Affairs Manager
Organization: Otto Bock Healthcare Products GmbH
Phone: 004315233786733
Responsible Party: Otto Bock Healthcare Products GmbH
ClinicalTrials.gov Identifier: NCT01116466     History of Changes
Other Study ID Numbers: PB-SA844-100
First Submitted: April 23, 2010
First Posted: May 5, 2010
Results First Submitted: July 22, 2013
Results First Posted: November 17, 2014
Last Update Posted: November 17, 2014