StrokeNCT04473391
Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System
A study testing Cycle-ergometer training assisted by FES for lower extremities in people with Stroke, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Cycle-ergometer training assisted by FES for lower extremities
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChile
- Study dates
- 1 Jan 2017to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Corporación de Rehabilitación Club de Leones Cruz del Sur
Punta Arenas, Region of Magallanes, 6211525
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Cycle-ergometer training assisted by FES for lower extremities
- Keywords
- Stroke, Hemiparesis, Gait, Functional Electrical Stimulation, Rehabilitation, Gait Deviation Index
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycle-ergometer training assisted by FES for lower extremitiesDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cycle-ergometer training assisted by FES for lower extremities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Deviation Index Baseline
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Measured: Baseline
Gait Deviation Index Post-Intervention
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Measured: 12 weeks
Secondary outcomes (2)
Gait Speed Baseline
Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
Measured: Baseline
Gait Speed Post-intervention
Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Jan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporación de Rehabilitación Club de Leones Cruz del Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asterio H Andrade Gallardo, MSc., Study chair, Corporación de Rehabilitacion Club de Leones Cruz del Sur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473391
- Sponsor's protocol ID
- CorporacionRCLCS0004
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15788341Belda-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.
PubMed 22165907Gage JR. Gait analysis. An essential tool in the treatment of cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):126-34.
PubMed 8458125Schwartz 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.
PubMed 18565753Popovic 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.
PubMed 19713618
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System
- ClinicalTrials.gov ID
- NCT04473391
- Acronym / sponsor ID
- CorporacionRCLCS0004
- Conditions
- Stroke
- Keywords
- Stroke, Hemiparesis, Gait, Functional Electrical Stimulation, Rehabilitation, Gait Deviation Index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Corporación de Rehabilitación Club de Leones Cruz del SurUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted Rehabilitation | Experimental | Device: Cycle-ergometer training assisted by FES for lower extremitiesParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- peripheral nervous system pathology
- epilepsy
- weight over 100 kg
- no cognitive ability to follow the study instructions
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycle-ergometer training assisted by FES for lower extremitiesThe 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 | Device | Robot-assisted Rehabilitation |
Primary outcome
Gait Deviation Index Baseline
Time frame: Baseline
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Gait Deviation Index Post-Intervention
Time frame: 12 weeks
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
2 secondary outcomes
Gait Speed Baseline
Time frame: Baseline
Gait Speed Post-intervention
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Background: PubMed 15788341Flansbjer 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.
- Background: PubMed 22165907Belda-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.
- Background: PubMed 8458125Gage JR. Gait analysis. An essential tool in the treatment of cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):126-34.
- Background: PubMed 18565753Schwartz 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.
- Background: PubMed 19713618Popovic 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.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asterio H Andrade Gallardo, MSc. study chair
Corporación de Rehabilitacion Club de Leones Cruz del Sur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycle-ergometer training assisted by FES for lower extremities in people with Stroke, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Deviation Index Baseline (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04473391, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.