Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile
1 other identifier
interventional
50
1 country
1
Brief Summary
This research will study the effects of a rehabilitation program assisted by a powered lower extremity exoskeleton in patients after stroke. It will compare clinical and biomechanical features of patients at baseline and after intervention. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jul 2019
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 8, 2020
CompletedFirst Posted
Study publicly available on registry
January 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedJuly 16, 2020
July 1, 2020
7 months
January 8, 2020
July 15, 2020
Conditions
Keywords
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 (21)
Maximal muscle strength Baseline
Baseline
Maximal muscle strength Post-Intervention
12 weeks
Distance in 6 Minute Walk Test (6MWT) Baseline
Baseline
Distance in 6 Minute Walk Test (6MWT) Post-Intervention
12 weeks
Muscle tone measured using modified ashworth scale (MAS) Baseline
Baseline
- +16 more secondary outcomes
Study Arms (2)
Robot-assisted Rehabilitation
EXPERIMENTALParticipants will receive Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain). Patients will perform lower limb exercises assisted by the device. Training involve 24 sessions, 2 sessions per week for 12 weeks, each lasting about 1 hour.
Conventional Gait Rehabilitation
ACTIVE COMPARATORParticipants in this group will perform conventional gait rehabilitation on a rehabilitation institution with assistance of a physical therapist. Training involve 24 sessions, 2 sessions per week, each session lasting about 1 hour.
Interventions
The H3 is a powered lower extremity exoskeleton with actuated at hips, knees and ankles joints. A novel control software has been design and implemented in this device, which allows selective joint movement and recording of data from each rehabilitation session.
Conventional gait rehabilitation consist in walking and other applicable lower limb exercises performed by participants with assistance of a physical therapist.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Corporación de Rehabilitación Club de Leones Cruz del Sur
Punta Arenas, Region of Magallanes, 6211525, Chile
Related Publications (4)
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: 15788341BACKGROUNDBelda-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: 22165907BACKGROUNDBortole M, Venkatakrishnan A, Zhu F, Moreno JC, Francisco GE, Pons JL, Contreras-Vidal JL. The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. J Neuroeng Rehabil. 2015 Jun 17;12:54. doi: 10.1186/s12984-015-0048-y.
PMID: 26076696BACKGROUNDWallard L, Dietrich G, Kerlirzin Y, Bredin J. Effects of robotic gait rehabilitation on biomechanical parameters in the chronic hemiplegic patients. Neurophysiol Clin. 2015 Sep;45(3):215-9. doi: 10.1016/j.neucli.2015.03.002. Epub 2015 Sep 14.
PMID: 26381192BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Asterio H Andrade Gallardo, MSc.
Corporación de Rehabilitacion Club de Leones Cruz del Sur
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2020
First Posted
January 14, 2020
Study Start
July 1, 2019
Primary Completion
January 31, 2020
Study Completion
March 31, 2020
Last Updated
July 16, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share