Not Signed In -
CPAP Device |
|
|
Clinical Trial: Functional Electrical Stimulation for Footdrop in Hemiparesis
This study is currently recruiting patients.
Verified by National Institute of Child Health and Human Development (NICHD) September 2005
|
Purpose
The objective of this research is to determine if electrical stimulation can improve the strength and coordination of the lower limb muscles, and the walking ability of stroke survivors.
The knowledge gained from this study may lead to enhancements in the quality of life of stroke survivors by improving their neurological recovery and mobility. The results may lead to substantial changes in the standard of care for the treatment of lower limb hemiparesis after stroke.
| Condition | Intervention | Phase |
|---|---|---|
| Stroke Hemiplegia | Device: Odstock Dropped-Foot Stimulator (ODFS) Device: Custom Molded Hinged Ankle Foot Orthosis (AFO) Procedure: Traditional Physical Therapy Treatment | Phase II |
MedlinePlus related topics: Paralysis; Stroke
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Secondary Outcomes: Quantitative Gait Analysis - Weeks 0, 12, 24, 36; Modified Emory Functional Ambulation Profile(mEFAP) - Weeks 0, 12, 24, 36; Stroke-Specific Quality of Life Scale (SS-QOL) - Weeks 0, 12, 24, 36; Electronic Activity Monitor (activPAL) 3 day monitor - weeks 0, 12, 24, 36; Optional Quantitative Gait Analysis of Orthotic Effect of ODFS - weeks 6-12
Expected Total Enrollment: 170
Study start: July 2005; Expected completion: December 2009
Last follow-up: October 2009; Data entry closure: November 2009
Eligibility
Accepts Healthy Volunteers
Inclusion Criteria:
- Stroke survivors > 90 days from 1st clinical hemorrhagic or nonhemorrhagic stroke
- Age: 18-75 years
- Unilateral hemiparesis
- Medically stable
- Intact skin in the affected lower limb
- Sufficient endurance & motor ability to ambulate at least 30 feet continuously with minimal assistance [requiring contact guard to no more than 25% physical help] or less without the use of an AFO
- Berg Balance Scale score of 24 or greater without any assistive devices
- Meet the ankle function clinical indication for a custom molded AFO
- Ankle dorsiflexion strength of no greater than 4/5 on the Medical Research Council (MRC) scale while standing
- Demonstrate foot-drop during ambulation such that gait instability [need for supervision, physical assistance or assistive device (cane, walker) to maintain balance or prevent falls] or inefficient gait patterns [gait pattern manifesting “dragging” or “catching” of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes]are exhibited
- Presence of posterior knee thrust acceptable
- Ankle dorsiflexion to at least neutral while standing in response to NMES of the common peroneal nerve without painful hypersensitivity to the NMES
- If using an AFO, willing to terminate its use and comply with study requirements
Exclusion Criteria:
- Require an AFO to maintain knee stability (prevention of knee flexion collapse) during stance phase of gait
- Edema of the affected lower limb
- Absent sensation
- History of potentially fatal cardiac arrhythmias, such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response atrial fibrillation with hemodynamic instability
- Demand pacemakers or any other implanted electronic systems
- Pregnant women
- Uncontrolled seizure disorder
- Ipsilateral lower limb lower motor neuron lesion
- Parkinson’s Disease
- Spinal cord injury
- Traumatic brain injury
- Multiple sclerosis
- Ankle plantar flexor contracture
- Hypersensitivity or non-reactivity to NMES of the common peroneal nerve
- Uncompensated hemineglect
- Severely impaired cognition and communication
- Severe Depression
- History of Botox to lower extremity during prior 3 months
- Inadequate social support and/or driving distance that compromises optimal compliance with study protocol
Location and Contact Information
Ohio
MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Recruiting
John Chae, MD, Principal Investigator
Lynne Sheffler, MD, Sub-Investigator
Ron Triolo, PhD, Sub-Investigator
Catherine Corrigan, RN, Sub-Investigator
Gregory Naples, Sub-Investigator
John Chae, MD, Principal Investigator, MetroHealth Medical Center
More Information
Publications
Burridge JH, Taylor PN, Hagan SA, Wood DE, Swain ID. The effects of common peroneal stimulation on the effort and speed of walking: a randomized controlled trial with chronic hemiplegic patients. Clin Rehabil. 1997 Aug;11(3):201-10.
Burridge J, Taylor P, Hagan S, Swain I. Experience of clinical use of the Odstock dropped foot stimulator. Artif Organs. 1997 Mar;21(3):254-60.
Burridge JH, McLellan DL. Relation between abnormal patterns of muscle activation and response to common peroneal nerve stimulation in hemiplegia. J Neurol Neurosurg Psychiatry. 2000 Sep;69(3):353-61.
Burridge JH, Wood DE, Taylor PN, McLellan DL. Indices to describe different muscle activation patterns, identified during treadmill walking, in people with spastic drop-foot. Med Eng Phys. 2001 Jul;23(6):427-34.
Taylor PN, Burridge JH, Dunkerley AL, Wood DE, Norton JA, Singleton C, Swain ID. Clinical use of the Odstock dropped foot stimulator: its effect on the speed and effort of walking. Arch Phys Med Rehabil. 1999 Dec;80(12):1577-83.
Taylor PN, Burridge JH, Dunkerley AL, Lamb A, Wood DE, Norton JA, Swain ID. Patients'''' perceptions of the Odstock Dropped Foot Stimulator (ODFS). Clin Rehabil. 1999 Oct;13(5):439-46.
Chae J, Bethoux F, Bohine T, Dobos L, Davis T, Friedl A. Neuromuscular stimulation for upper extremity motor and functional recovery in acute hemiplegia. Stroke. 1998 May;29(5):975-9.
Francisco G, Chae J, Chawla H, Kirshblum S, Zorowitz R, Lewis G, Pang S. Electromyogram-triggered neuromuscular stimulation for improving the arm function of acute stroke survivors: a randomized pilot study. Arch Phys Med Rehabil. 1998 May;79(5):570-5.
Teasell RW, Bhogal SK, Foley NC, Speechley MR. Gait retraining post stroke. Top Stroke Rehabil. 2003 Summer;10(2):34-65.
Teasell RW, Foley NC, Bhogal SK, Speechley MR. An evidence-based review of stroke rehabilitation. Top Stroke Rehabil. 2003 Spring;10(1):29-58. Review.
LIBERSON WT, HOLMQUEST HJ, SCOT D, DOW M. Functional electrotherapy: stimulation of the peroneal nerve synchronized with the swing phase of the gait of hemiplegic patients. Arch Phys Med Rehabil. 1961 Feb;42:101-5. No abstract available.
Waters RL, McNeal D, Perry J. Experimental correction of footdrop by electrical stimulation of the peroneal nerve. J Bone Joint Surg Am. 1975 Dec;57(8):1047-54.
Waters RL, McNeal DR, Clifford B. Correction of footdrop in stroke patients via surgically implanted peroneal nerve stimulator. Acta Orthop Belg. 1984 Mar-Apr;50(2):285-95. No abstract available.
Kljajic M, Malezic M, Acimovic R, Vavken E, Stanic U, Pangrsic B, Rozman J. Gait evaluation in hemiparetic patients using subcutaneous peroneal electrical stimulation. Scand J Rehabil Med. 1992 Sep;24(3):121-6.
Merletti R, Andina A, Galante M, Furlan I. Clinical experience of electronic peroneal stimulators in 50 hemiparetic patients. Scand J Rehabil Med. 1979;11(3):111-21.
Granat MH, Maxwell DJ, Ferguson AC, Lees KR, Barbenel JC. Peroneal stimulator; evaluation for the correction of spastic drop foot in hemiplegia. Arch Phys Med Rehabil. 1996 Jan;77(1):19-24.
Takebe K, Kukulka C, Narayan MG, Milner M, Basmajian JV. Peroneal nerve stimulator in rehabilitation of hemiplegic patients. Arch Phys Med Rehabil. 1975 Jun;56(6):237-9.
Takebe K, Basmajian JV. Gait analysis in stroke patients to assess treatments of foot-drop. Arch Phys Med Rehabil. 1976 Jul;57(1):305-10.
Carnstam B, Larsson LE, Prevec TS. Improvement of gait following functional electrical stimulation. I. Investigations on changes in voluntary strength and proprioceptive reflexes. Scand J Rehabil Med. 1977;9(1):7-13.
Last Updated: September 6, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00148343
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13
email this page
print this page
bookmark this page
feedback on this page
