Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System

Stroke Clinical Trial

Official title:

Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04473391
• Other study ID #: CorporacionRCLCS0004
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2020
• Source: Corporación de Rehabilitación Club de Leones Cruz del Sur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Functional electrical stimulation is a modality of motor rehabilitation that consists of the programmed application of bursts of electrical current to the affected neuromuscular region that aims to improve muscle strength, increase the range of motion, facilitate movement control and decrease spasticity. The present study aimed to measure the changes in the biomechanics of the gait of people with Stroke after training with functional electrical stimulation for the lower extremities.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Cycle-ergometer training assisted by FES for lower extremities
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

Locations

Country	Name	City	State
Chile	Corporación de Rehabilitación Club de Leones Cruz del Sur	Punta Arenas	XII Región

Sponsors (1)

Lead Sponsor	Collaborator
Corporación de Rehabilitación Club de Leones Cruz del Sur

Country where clinical trial is conducted

Chile, 

References & Publications (5)

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. Review. — View Citation

Flansbjer UB, Holmbäck 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. — View Citation

Gage JR. Gait analysis. An essential tool in the treatment of cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):126-34. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Deviation Index Baseline	Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.	Baseline
Primary	Gait Deviation Index Post-Intervention	Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.	12 weeks
Secondary	Gait Speed Baseline	Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.	Baseline
Secondary	Gait Speed Post-intervention	Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.	12 weeks