- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04473391
Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is one of the leading causes of mortality, morbidity and disability in adults in developed countries. Survivors may suffer several neurological deficits or deficiencies, such as hemiparesis, communication disorders, cognitive deficits and visuospatial perception disorders. Hemiplegia is a par loss of hemi-body voluntary motricity following a brain injury, usually resulting in alterations of the locomotor system with persistent disorders of movement and posture. Hemiplegia significantly affects gait performance. Gait recovery is an important objective in the rehabilitation program for stroke patients.The currently available treatment techniques include classical techniques of gait rehabilitation, functional electrical stimulation, electromechanic devices, robotic devices and brain-computer interfaces, among others.The evidence suggest that the combination of different rehabilitation strategies is more effective than conventional rehabilitation techniques alone. Technology-based rehabilitation methods such as robotic devices need more research to demonstrate their effects on gait recovery.
The present study aimed to identify the changes in the gait characteristics of subjects with stroke after a treatment program with FES for the lower extremities through instrumental gait analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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XII Región
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Punta Arenas, XII Región, Chile, 6211525
- Corporación de Rehabilitación Club de Leones Cruz del Sur
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- unilateral lower extremity paresis
- haemorrhagic or ischemic stroke
- a minimum of six months after the acute infarction/onset of the disease
- full passive range of motion in lower extremity or at least at neutral position
- be able to stand freely
- be able to walk with or without aid for at least 20 meters in less than 2 minutes
Exclusion Criteria:
- peripheral nervous system pathology
- epilepsy
- weight over 100 kg
- no cognitive ability to follow the study instructions
- pregnancy
- use of implanted devices
- instable lower extremity joints or fixed contracture
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Robot-assisted Rehabilitation
Participants will receive Functional Electrical Stimulation (FES) training with a lower extremity cycle-ergometer (MOTOmed Viva 2, Reck GmbH., Germany) and a 6-channel FES Device (TrainFES, Biomedical Devices SpA, Chile).
Patients will perform lower limb exercises assisted by the device.
Training involve 24 sessions, 3 sessions per week for 8 weeks, each lasting about 45 minutes.
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The intervention consists of FES treatment sessions on a cycle ergometer for the lower extremities.
Each subject received 24 sessions lasting 45 minutes each and a frequency of 3 sessions per week.
The sessions will be applied by a physiotherapist with experience in electrotherapy.
A 6-channel FES device (TrainFES, Biomedical Devices SpA, Chile) will be used, which consists of a stimulator unit of 95x50x30mm and 100g of weight coupled to the motorized cycle ergometer (MOTOmed Viva 2, Reck GmbH., Germany), a remote user interface consisting of an android application for the configuration of the stimulation via Bluetooth 3.1, and an inertial measurement unit positioned on the rotation axis of the cycle ergometer to detect the rotations and trigger the synchronized electrical stimulation according to the stimulation pattern pre-configured for the pedaling exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait Deviation Index Baseline
Time Frame: Baseline
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Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
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Baseline
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Gait Deviation Index Post-Intervention
Time Frame: 12 weeks
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Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait Speed Baseline
Time Frame: Baseline
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Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
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Baseline
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Gait Speed Post-intervention
Time Frame: 12 weeks
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Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
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12 weeks
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Collaborators and Investigators
Publications and helpful links
General Publications
- Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.
- Belda-Lois JM, Mena-del Horno S, Bermejo-Bosch I, Moreno JC, Pons JL, Farina D, Iosa M, Molinari M, Tamburella F, Ramos A, Caria A, Solis-Escalante T, Brunner C, Rea M. Rehabilitation of gait after stroke: a review towards a top-down approach. J Neuroeng Rehabil. 2011 Dec 13;8:66. doi: 10.1186/1743-0003-8-66.
- Gage JR. Gait analysis. An essential tool in the treatment of cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):126-34.
- Schwartz MH, Rozumalski A. The Gait Deviation Index: a new comprehensive index of gait pathology. Gait Posture. 2008 Oct;28(3):351-7. doi: 10.1016/j.gaitpost.2008.05.001. Epub 2008 Jun 18.
- Popovic DB, Sinkaer T, Popovic MB. Electrical stimulation as a means for achieving recovery of function in stroke patients. NeuroRehabilitation. 2009;25(1):45-58. doi: 10.3233/NRE-2009-0498.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CorporacionRCLCS0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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