NCT01029912|CompletedResults
Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors
Contralaterally Controlled NMES in Chronic Ankle Dorsiflexor Paresis After Stroke
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Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
26
1 country
1
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2011
Actual (reported)Study Completion
August 2011
Actual (reported)Ankle dorsiflexor weakness (paresis) is one of the most frequently persisting consequences of stroke. The purpose of this exploratory study is to compare two different treatments -- Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) and Cyclic Neuromuscular Electrical Stimulation (cNMES) -- for improved recovery of ankle movement and better walking after stroke.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 9, 2009
Actual (reported)December 10, 2009
Actual (reported)August 2011
Actual (reported)August 2011
Actual (reported)November 6, 2017
Actual (reported)Change in Lower Extremity Fugl-Meyer Score at End of Treatment
The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0. Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged.
2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
Change in Gait Velocity (cm/Sec) at End of Treatment
Gait velocity was assessed using a motion capture and analysis system which collected spatio-temporal data as the participant walked 5-meters 10 times at a self-selected comfortable speed within the field of view of the motion capture system. A higher gait velocity is considered to be a better outcome. For each individual, the gait velocity prior to treatment was subtracted from the gait velocity at end of the 6-week treatment. Then for each treatment group, these change values were averaged.
Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) Electrical Stimulator
Cyclic Neuromuscular Electrical Stimulation (NMES) Electrical Stimulator
6-week intervention 15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week. Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Nudo RJ, Wise BM, SiFuentes F, Milliken GW. Neural substrates for the effects of rehabilitative training on motor recovery after ischemic infarct. Science. 1996 Jun 21;272(5269):1791-4. doi: 10.1126/science.272.5269.1791.
Luft AR, McCombe-Waller S, Whitall J, Forrester LW, Macko R, Sorkin JD, Schulz JB, Goldberg AP, Hanley DF. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004 Oct 20;292(15):1853-61. doi: 10.1001/jama.292.15.1853.
Jayme S. Knutson, PhD
Case Western Reserve University
26 participants (actual enrollment reported by the registry).
First Submitted
December 9, 2009
First Posted
December 10, 2009
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Therapies for Recovery of Hand Function After Stroke
2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
Change in Time (Sec) to Complete the Modified Emory Functional Ambulation Profile (MEFAP).
The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time. Lower times are considered to be a better outcome. For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged.
2 timepoints: Prior to treatment, and End of treatment at 6 weeks.
Contact the study team to confirm eligibility.
Robbins SM, Houghton PE, Woodbury MG, Brown JL. The therapeutic effect of functional and transcutaneous electric stimulation on improving gait speed in stroke patients: a meta-analysis. Arch Phys Med Rehabil. 2006 Jun;87(6):853-9. doi: 10.1016/j.apmr.2006.02.026.
Rushton DN. Functional electrical stimulation and rehabilitation--an hypothesis. Med Eng Phys. 2003 Jan;25(1):75-8. doi: 10.1016/s1350-4533(02)00040-1.
Khaslavskaia S, Sinkjaer T. Motor cortex excitability following repetitive electrical stimulation of the common peroneal nerve depends on the voluntary drive. Exp Brain Res. 2005 May;162(4):497-502. doi: 10.1007/s00221-004-2153-1. Epub 2005 Feb 9.
Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20. doi: 10.1016/j.apmr.2007.01.003.
Knutson JS, Hisel TZ, Harley MY, Chae J. A novel functional electrical stimulation treatment for recovery of hand function in hemiplegia: 12-week pilot study. Neurorehabil Neural Repair. 2009 Jan;23(1):17-25. doi: 10.1177/1545968308317577. Epub 2008 Sep 23.
Sheffler LR, Hennessey MT, Naples GG, Chae J. Peroneal nerve stimulation versus an ankle foot orthosis for correction of footdrop in stroke: impact on functional ambulation. Neurorehabil Neural Repair. 2006 Sep;20(3):355-60. doi: 10.1177/1545968306287925.
Primary Completion
August 2011
Actual (reported)Study Completion
August 2011
Actual (reported)Last Updated
December 7, 2017
Results First Posted
November 6, 2017
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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