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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Cycle-ergometer training assisted by FES for lower extremities
Sponsored by
Corporación de Rehabilitación Club de Leones Cruz del Sur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Hemiparesis, Gait, Functional Electrical Stimulation, Rehabilitation, Gait Deviation Index

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Corporación de Rehabilitación Club de Leones Cruz del Sur

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robot-assisted Rehabilitation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Gait Speed Baseline
Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
Gait Speed Post-intervention
Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.

Full Information

First Posted
July 13, 2020
Last Updated
July 13, 2020
Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur
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1. Study Identification

Unique Protocol Identification Number
NCT04473391
Brief Title
Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System
Official Title
Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Hemiparesis, Gait, Functional Electrical Stimulation, Rehabilitation, Gait Deviation Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot-assisted Rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cycle-ergometer training assisted by FES for lower extremities
Intervention Description
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
Primary Outcome Measure Information:
Title
Gait Deviation Index Baseline
Description
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Time Frame
Baseline
Title
Gait Deviation Index Post-Intervention
Description
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Gait Speed Baseline
Description
Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
Time Frame
Baseline
Title
Gait Speed Post-intervention
Description
Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asterio H Andrade Gallardo, MSc.
Organizational Affiliation
Corporación de Rehabilitacion Club de Leones Cruz del Sur
Official's Role
Study Chair
Facility Information:
Facility Name
Corporación de Rehabilitación Club de Leones Cruz del Sur
City
Punta Arenas
State/Province
XII Región
ZIP/Postal Code
6211525
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15788341
Citation
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.
Results Reference
background
PubMed Identifier
22165907
Citation
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.
Results Reference
background
PubMed Identifier
8458125
Citation
Gage JR. Gait analysis. An essential tool in the treatment of cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):126-34.
Results Reference
background
PubMed Identifier
18565753
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.
Results Reference
background
PubMed Identifier
19713618
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.
Results Reference
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Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System

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