Healthy Clinical Trial
Official title:
A Wearable for Post-stroke Rehabilitative Multi-muscle Stimulation Inspired by the Natural Organization of Neuromuscular Control
Participants are seeking to unleash the full therapeutic potential of a newly developed, customizable and potentially commericializable 10-channel Functional Electrical Stimulation (FES) to rehabilitate the gait of chronic stroke survivors. Patricipants will utilize the theory of muscle synergies from motor neurosciences, which are defined as neural modules of motor control that coordinate the spatiotemporal activation patterns of multiple muscles, to guide our personal selections of muscles for FES. Before applying FES stimulations to chronic stroke survivors, participants will have to define normal muscle synergies from age-matched healthy control participants (1 session for each participant). After comparing the difference in muscle synergies in both healthy subjects and chronic stroke survivors, participants are attempting to rehabilitate the gait of chronic stroke survivors by using the wearable. Each chronic stroke survivor will undergo 18-session FES training (~ 1 month). It is hypothesized that FES will promote motor recovery by supplying the missing normal muscle synergies to chronic stroke survivors at their supposed times of activations in each step cycle during interventional training. It is also expected that the walk synergies of the paretic side of chronic stroke survivors should be more similar to healthy muscle synergies at the two post-training time points than before training. The healthy normal muscle synergies will be defined by EMG recordings from the recruited healthy participants.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | June 23, 2024 |
Est. primary completion date | March 23, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | Inclusion Criteria: For chronic stroke survivors: 1. Right-handed elderly chronic stroke survivors; age =40; =6 months post-stroke 2. Unilateral ischemic brain lesions 3. Participants should be able to walk continuously for =15 min. with or without assistive aid For healthy participants: 1. Healthy, right-handed subjects, age =40, free from any history of major neurological, musculoskeletal, and psychiatric disorders 2. Able to walk continuously for =20 min. without fatigue. Exclusion Criteria: For both healthy participants and chronic stroke survivors: 1. Cannot comprehend and follow instructions, or with a score <21 on the mini-mental state exam; 2. Have cardiac pacemaker; 3. Have skin lesions at the locations where FES or EMG electrodes may be attached; 4. Have major depression; 5. Present with severe neglect |
Country | Name | City | State |
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Hong Kong | The Hong Kong Polytechnic University | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong | City University of Hong Kong, Shanghai Jiao Tong University School of Medicine, The Hong Kong Polytechnic University |
Hong Kong,
Barroso FO, Torricelli D, Molina-Rueda F, Alguacil-Diego IM, Cano-de-la-Cuerda R, Santos C, Moreno JC, Miangolarra-Page JC, Pons JL. Combining muscle synergies and biomechanical analysis to assess gait in stroke patients. J Biomech. 2017 Oct 3;63:98-103. doi: 10.1016/j.jbiomech.2017.08.006. Epub 2017 Aug 20. — View Citation
Ferrante S, Chia Bejarano N, Ambrosini E, Nardone A, Turcato AM, Monticone M, Ferrigno G, Pedrocchi A. A Personalized Multi-Channel FES Controller Based on Muscle Synergies to Support Gait Rehabilitation after Stroke. Front Neurosci. 2016 Sep 16;10:425. doi: 10.3389/fnins.2016.00425. eCollection 2016. — View Citation
Heller BW, Clarke AJ, Good TR, Healey TJ, Nair S, Pratt EJ, Reeves ML, van der Meulen JM, Barker AT. Automated setup of functional electrical stimulation for drop foot using a novel 64 channel prototype stimulator and electrode array: results from a gait-lab based study. Med Eng Phys. 2013 Jan;35(1):74-81. doi: 10.1016/j.medengphy.2012.03.012. Epub 2012 May 4. — View Citation
Krasovsky T, Levin MF. Review: toward a better understanding of coordination in healthy and poststroke gait. Neurorehabil Neural Repair. 2010 Mar-Apr;24(3):213-24. doi: 10.1177/1545968309348509. Epub 2009 Oct 12. — View Citation
Peckham PH, Knutson JS. Functional electrical stimulation for neuromuscular applications. Annu Rev Biomed Eng. 2005;7:327-60. doi: 10.1146/annurev.bioeng.6.040803.140103. — View Citation
Sheffler LR, Chae J. Neuromuscular electrical stimulation in neurorehabilitation. Muscle Nerve. 2007 May;35(5):562-90. doi: 10.1002/mus.20758. — View Citation
Springer S, Vatine JJ, Wolf A, Laufer Y. The effects of dual-channel functional electrical stimulation on stance phase sagittal kinematics in patients with hemiparesis. J Electromyogr Kinesiol. 2013 Apr;23(2):476-82. doi: 10.1016/j.jelekin.2012.10.017. Epub 2012 Dec 8. — View Citation
You G, Liang H, Yan T. Functional electrical stimulation early after stroke improves lower limb motor function and ability in activities of daily living. NeuroRehabilitation. 2014;35(3):381-9. doi: 10.3233/NRE-141129. — View Citation
Zhuang C, Marquez J, Qu H, He X, Lan N (2015) A neuromuscular electrical stimulation strategy based on muscle synergy for stroke rehabilitation. 2015:816-819.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surface electromyographic signals from up to 14 muscles on each side of healthy participants during gait. | To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes. | The assessment will be performed at 1 week | |
Primary | Surface electromyographic signals from up to 14 muscles on the paretic and non-paretic side during gait. | To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes. | The assessment will be performed at baseline | |
Primary | Surface electromyographic signals from up to 14 muscles on the paretic and non-paretic side during gait. | To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes. | The assessment will be performed at 5.5 weeks | |
Primary | Surface electromyographic signals from up to 14 muscles on the paretic and non-paretic side during gait. | To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes. | The assessment will be performed at 2.5 weeks | |
Primary | Surface electromyographic signals from up to 14 muscles on the paretic and non-paretic side during gait. | To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes. | The assessment will be performed at 4 weeks | |
Secondary | Measuring Gait kinematics from Healthy Participants | Kinematic measurements will be provided by the wearable's IMUs. During assessments, we will capture more precise kinematics using a 10-camera motion capture system (VICON; 200 Hz). This system tracks the 3D positions of 40 markers placed on the legs and torso, and is equipped with suitable models for reconstructing bilateral angles of the hip, knee and ankle. | The assessment will be performed at 1 week | |
Secondary | Measuring Gait kinematics from Chronic Stroke Survivors | During FES sessions, kinematic measurements will be provided by the wearable's IMUs. During sessions of motor-impairment assessments, we will capture more precise kinematics using a 10-camera motion capture system (VICON; 200 Hz). This system tracks the 3D positions of 40 markers placed on the legs and torso, and is equipped with suitable models for reconstructing bilateral angles of the hip, knee and ankle. | The assessment will be performed at baseline | |
Secondary | Measuring Gait kinematics from Chronic Stroke Survivors | During FES sessions, kinematic measurements will be provided by the wearable's IMUs. During sessions of motor-impairment assessments, we will capture more precise kinematics using a 10-camera motion capture system (VICON; 200 Hz). This system tracks the 3D positions of 40 markers placed on the legs and torso, and is equipped with suitable models for reconstructing bilateral angles of the hip, knee and ankle. | The assessment will be performed at 5.5 weeks | |
Secondary | Measuring Gait kinematics from Chronic Stroke Survivors | During FES sessions, kinematic measurements will be provided by the wearable's IMUs. During sessions of motor-impairment assessments, we will capture more precise kinematics using a 10-camera motion capture system (VICON; 200 Hz). This system tracks the 3D positions of 40 markers placed on the legs and torso, and is equipped with suitable models for reconstructing bilateral angles of the hip, knee and ankle. | The assessment will be performed at 2.5 weeks | |
Secondary | Measuring Gait kinematics from Chronic Stroke Survivors | During FES sessions, kinematic measurements will be provided by the wearable's IMUs. During sessions of motor-impairment assessments, we will capture more precise kinematics using a 10-camera motion capture system (VICON; 200 Hz). This system tracks the 3D positions of 40 markers placed on the legs and torso, and is equipped with suitable models for reconstructing bilateral angles of the hip, knee and ankle. | The assessment will be performed at 4 weeks | |
Secondary | Fugl-Meyer assessment score (lower-limb) | Lower-limb motor function assessment | The assessment will be performed at baseline | |
Secondary | Fugl-Meyer assessment score (lower-limb) | Lower-limb motor function assessment | The assessment will be performed at 5.5 weeks | |
Secondary | Fugl-Meyer assessment score (lower-limb) | Lower-limb motor function assessment | The assessment will be performed at 2.5 weeks | |
Secondary | Fugl-Meyer assessment score (lower-limb) | Lower-limb motor function assessment | The assessment will be performed at 4 weeks | |
Secondary | Mini-BEStest | Balance test | The assessment will be performed at baseline | |
Secondary | Mini-BEStest | Balance test | The assessment will be performed at 5.5 weeks | |
Secondary | Mini-BEStest | Balance test | The assessment will be performed at 2.5 weeks | |
Secondary | Mini-BEStest | Balance test | The assessment will be performed at 4 weeks |
Status | Clinical Trial | Phase | |
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