A Wearable for Post-stroke Rehabilitative Multi-muscle Stimulation Inspired by the Natural Organization of Neuromuscular Control

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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. Each subject will undergo 18-sessions (\ 1 month) FES training. Participants 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. It is hypothesized that chronic stroke survivors will learn from FES stimulations, over several daily sessions, both by suppressing the original abnormal muscle synergies and by employing the normal muscle synergies as specified in the FES. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• Right-handed elderly chronic stroke survivors; age ≥40; ≥6 months post-stroke

• Unilateral ischemic brain lesions

• Participants should be able to walk continuously for ≥15 min. with or without assistive aid

Locations
Other Locations
Hong Kong Special Administrative Region
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
Contact Information
Primary
Vincent Chi Kwan Cheung, PhD
vckc@cuhk.edu.hk
+852 3943 9389
Backup
Roy Tsz Hei Cheung, PhD
roy.cheung@polyu.edu.hk
+852 2766 6739
Time Frame
Start Date: 2019-02-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 45
Treatments
Experimental: Delivering FES to stroke survivors
In stroke survivors, normal and abnormal muscle synergies will also be determined from their walk EMGs. Our proposed FES intervention involves delivering stimulations to muscles with waveforms generated from the activations of all the normal synergies not observed in each stroke survivor. We are going to employ the wearable to deliver personalized muscle-synergy-based FES stimulations to multiple groups of leg muscles on the stroke-affected side of elderly chronic stroke survivors as they walk on a treadmill/overground for gait rehabilitation. We hypothesized that the subject will essentially be walking with his/her abnormal muscle pattern superimposed with the artificially introduced normal muscle pattern coming from FES.
Experimental: Delivery no current FES to stroke survivors (Sham group)
In stroke survivors, normal and abnormal muscle synergies will also be determined from their walk EMGs. Our proposed FES intervention involves delivering stimulations to muscles with waveforms generated from the activations of all the normal synergies not observed in each stroke survivor. Additionally, we are going to introduce a sham group. We are going to employ the wearable to multiple groups of leg muscles on the stroke-affected side of elderly chronic stroke survivors without any stimulation as they walk on a treadmill or overground for gait rehabilitation. The purpose of the sham group is to empirically validate the effectiveness of the FES wearable.
Related Therapeutic Areas
Sponsors
Collaborators: City University of Hong Kong, Shanghai Jiao Tong University School of Medicine, The Hong Kong Polytechnic University
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov