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
|Condition or disease||Intervention/treatment|
|Stroke Hemiplegia||Device: ActiGait|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study to Evaluate the Implantation of the ActiGait Drop Foot Stimulator System|
|Study Start Date :||August 2009|
|Primary Completion Date :||March 2010|
|Study Completion Date :||March 2010|
Receiving ActiGait - implantable drop foot stimulator
ActiGait - implantable drop foot stimulator
- Distance Walked in 6 Minutes [ Time Frame: Baseline, 6 and 12 weeks post-implantation ]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.
- Walking Speed During 10 Meter Gait Test [ Time Frame: Baseline, 6 and 12 weeks post-implantation ]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.
- Canadian Occupational Performance Measure (COPM) Score [ Time Frame: Baseline,12 weeks post-implantation ]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.
- Four Square Step Test (FSST) [ Time Frame: Baseline, week 12 post-implantation ]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.
- Nerve Conduction Velocity of the Peroneal Nerve [ Time Frame: Baseline, week 12 post-implantation ]Measured: Nervus peroneus communis (CPN) and Nervus peroneus superficialis (SPN)
- Change in MRI of Affected Leg and Implant Post-implantation [ Time Frame: Week 3 post-implantation ]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.)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116466
|Principal Investigator:||David Liebetanz, MD||Medical University Georg-August-University Goettingen, Germany|
|Principal Investigator:||Veit Rhode, MD||Medical University Georg-August-University Goettingen, Germany|