Exoskeleton Robotic Assisted Gait Training in Spastic Stroke Post Botulinum Toxin a Injection

NARecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

July 31, 2025

Study Completion Date

July 31, 2025

Conditions
Spastic GaitSpastic
Interventions
PROCEDURE

BoNT-A injections

Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.

OTHER

BoNT-A injection and robot therapy

"Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton links to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs."

OTHER

None BoNT-A injection and robot therapy

"Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton links to the user. Patients will wear receive exoskeleton lower extremity robot (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs."

Trial Locations (1)

833

RECRUITING

Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan, Kaohsiung City

All Listed Sponsors
lead

Chang Gung Memorial Hospital

OTHER