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Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

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ClinicalTrials.gov Identifier: NCT00864708
Recruitment Status : Terminated (The enrollment period/study duration had exceeded The Alfred Mann Foundation's timeline.)
First Posted : March 19, 2009
Results First Posted : May 26, 2014
Last Update Posted : May 26, 2014
Sponsor:
Collaborator:
The Alfred E. Mann Foundation for Scientific Research
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stroke
Intervention Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Enrollment 1
Recruitment Details Dec 2008 – October 2009, recruitment by flier and by word of mouth
Pre-assignment Details  
Arm/Group Title Arm 1
Hide Arm/Group Description Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Arm 1
Hide Arm/Group Description Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
This was a feasibility study to test an RFM Gait System for re-training gait coordination. Number of participants was limited to sponsor timeline.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
37  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Walking Endurance (6MWT)
Hide Description The Six Minute Walk Test (6MWT) is a measure of the distance measured in feet ambulated by the participant during six minutes. A further distance walked in 6 minutes indicates improvement on the measure.
Time Frame Day 1 and at 3 months, following treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1
Hide Arm/Group Description:
gait training with radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: feet
Day 1-6MWT 843
After 3 months of treatment- 6MWT 771
2.Primary Outcome
Title Kinematic Gait Measures
Hide Description assessment of the lower limb kinematics during ambulation at chosen speed.
Time Frame Day 1 and at 3 months, following treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1
Hide Arm/Group Description:
Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: percentage of change Day 1 to 3 months
0
3.Secondary Outcome
Title Fugl-Meyer Lower Extremity Score
Hide Description Fugl-Meyer Lower Extremity Score (FMLE) is an itemized measure of lower extremity coordination following stroke. Scores for the FMLE range from 0 (most impaired) to 34 (normal).
Time Frame Day 1 and at 3 months, following treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1
Hide Arm/Group Description:
Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: units on a scale
Day 1- Fugl Meyer Score 22
After 3 months of treatment- Fugl Meyer Score 26
4.Secondary Outcome
Title Ashworth Scale
Hide Description The Ashworth Scale is a measure of muscle spasticity; muscle groups are graded from 0 (no spasticity) to 4 (greatest spasticity/contracture). The lower limb muscle groups are summed for a total lower limb Ashworth score. A lower score indicates better performance. (range is 0-40)
Time Frame Day 1 and at 3 months, following treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1
Hide Arm/Group Description:
Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: units on a scale
Day 1-Ashworth Score 1.5
After 3 months of treatment- Ashworth Score 1.0
5.Secondary Outcome
Title Stroke Impact Scale (SIS)
Hide Description The SIS is a measure of Quality of Life/Life Role Participation following stroke. Each item in a domain is scored between 0 and 5. A higher score indicates better performance (range 0-295).
Time Frame Day 1 and at 3 months, following treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1
Hide Arm/Group Description:
Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: units on a scale
Day 1-SIS 261
After 3 months of treatment- SIS 264
6.Secondary Outcome
Title Manual Muscle Testing (MMT)
Hide Description This is a measure of strength of the various muscle groups of the lower limb. Each is graded on a 0 to 5 scale; the final score is the summed total of the lower limb muscle groups tested. (score range of summed muscles is 0-50, with 50 being the maximum highest score)
Time Frame Day 1 and at 3 months, following treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1
Hide Arm/Group Description:
Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: units on a scale
Day 1-MMT 21.35
After 3 months of treatment- MMT 23.33
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1
Hide Arm/Group Description Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
All-Cause Mortality
Arm 1
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Musculoskeletal and connective tissue disorders   
delivery of unactivated stimuli (within comfort) * [1]  1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
RFM system delivered unactivated stimuli (always reported within comfort) to subject unpredictably at times when system was powered up. AMF submitted device re-test data and reports to FDA which then re-approved continued use of the RFM system.
Study sponsor, Alfred Mann foundation (AMF) stopped study because “enrollment period/study duration has exceeded the AMF’s timeline”.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.

Principal Investigators are employed by the Department of Veterans Affairs (DVA) which funded the study; the Alfred P. Mann Foundation (AMF) provided the technology that was tested.

There was an agreement between the Principal Investigators of the DVA and the AMF that the AMF would be provided a period of time to review any manuscript for publication and provide input. There was no restriction regarding PI’s rights to discuss or publish the results.

Results Point of Contact
Name/Title: Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center of Excellence
Organization: NF/SG VA Medical Center, Gainesville Florida
Phone: (352) 376-1611 ext 5223
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00864708     History of Changes
Other Study ID Numbers: B3252-R
B3513R ( Other Grant/Funding Number: Department of Veterans Affairs )
First Submitted: March 17, 2009
First Posted: March 19, 2009
Results First Submitted: November 25, 2013
Results First Posted: May 26, 2014
Last Update Posted: May 26, 2014