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

NCT04473391 | Unknown

• 1 other identifier: CorporacionRCLCS0004
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Hemiparesis; Gait; Functional Electrical Stimulation; Rehabilitation; Gait Deviation Index

Outcome Measures

Primary Outcomes (2)

• Gait Deviation Index Baseline

  Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.

  Baseline

• 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 Outcomes (2)

• Gait Speed Baseline

  Baseline

• Gait Speed Post-intervention

  12 weeks

Study Arms (1)

Robot-assisted Rehabilitation

EXPERIMENTAL

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.

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

Interventions

Cycle-ergometer training assisted by FES for lower extremities DEVICE

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

Robot-assisted Rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporación de Rehabilitación Club de Leones Cruz del Sur: lead

Study Sites (1)

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, 6211525, Chile

Location

Related Publications (5)

• 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.

  PMID: 15788341 BACKGROUND

• 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.

  PMID: 22165907 BACKGROUND

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

  PMID: 8458125 BACKGROUND

• 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.

  PMID: 18565753 BACKGROUND

• 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.

  PMID: 19713618 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Asterio H Andrade Gallardo, MSc.

  Corporación de Rehabilitacion Club de Leones Cruz del Sur

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: January 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)