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

Spastic Clinical Trial

Official title:

To Estimate the Efficacy of Botulinum Toxin A Injection Combing With Exoskeleton Robotic Assisted Gait Training in Stroke Patients With Spastic Stiff Knee Gait: Motor Function Performance and Neurophysiological Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06070987
• Other study ID #: NMRPG8N0051
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: September 2023
• Source: Chang Gung Memorial Hospital
• Contact: Hung Jen-Wen
• Phone: +886975056689
• Email: hung0702[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A(BoNT-A) injection with exoskeleton Robotic assisted gait training (RABT) in patients with post-stroke stiff-knee gait.

Description:

The aim of the study is to evaluate the effects of BoNT-A combining with overground exoskeleton robot for patients with post-stroke stiff-knee gait. Stiff-knee gait (SKG) is a common gait pattern in patients after stroke, characterized by limited knee flexion (KF) during the swing phase of walking. Botulinum toxin A (BoNT-A) injection in rectus femoris muscle is considered the gold standard procedure to treat SKG. Patients with this gait pattern would reduce walking speed, cause toe dragging, compromise the stability of walking, increase risk of falling, and interfere with daily activities. This randomized controlled trial will contribute to the accelerated refinement and development of efficient and effective treatment programs for patients with post-stroke spastic stiff knee gait. The Robot-assisted gait training (RAGT) has the potential to be an optimal adjunctive therapy following BoNT-A treatment. Combinations of BoNT-A and rehabilitation training are suggested to optimize the treatment effect for spasticity related disabilities.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Ischemic or hemorrhagic stroke = 3 months
• Age = 20 years
• Functional Ambulation Category =4
• Affected rectus femoris spasticity (MAS between 1+ and 2)
• BoNT-A treatment-naive or treated with BoNT-A =4 months in the affected leg before recruitment
• Receiving oral muscle relaxants or other medication for spasticity were on a stable dose for=2 months
• Can obey simple order

Exclusion Criteria:

• Pregnant
• Sensitivity to BoNT-A
• Infection of the skin, soft tissue in the injection area
• Participation in other trials
• Fixed contractures or bony deformities in the affected leg
• Previous treatment of the affected leg with neurolytic or surgical procedures (i.e., phenol block, tendon lengthening of transfer, tenotomy, muscle release, arthrodesis)
• Severe cardiovascular comorbidity (i.e., recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension)

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Muscle Spasticity
• Spastic
• Spastic Gait

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

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* Note: There are 68 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Kinematic analysis	Investigators will use a marker less motion capture system for kinematic analysis, use four high-definition cameras to record 30 fps at a resolution of 4 megapixels. The camera was placed uniformly 5 meters away from the center of the subject at the height of1meter, allowing for a maximum number of detections of the entire body. To analyze the kinematics of lower extremity, investigators use Open Pose, a real-time multi-person system, to detect human pose in 2D images Fromm the four high-definition cameras. Investigators will use this test to measure the angle of knee flexion and the step length (cm) of participants.	Change from baseline at 5 months
Other	Gait Assessment and Intervention Tool	GAIT is made up of 31 items divided into 3 sections, which correspond to 3 phases of the gait cycle. Items have 3 possible scores: 0-1, 0-2, and 0-3 points. The maximum punctuation is 64 points that indicates a maximal deficit of the patient gait pattern. Investigators use Gait Assessment and Intervention Tool (GAIT) to do clinical gait observation assessment.	Change from baseline at 5 months
Other	Nottingham Extended Activities of Daily Living Index	The Nottingham Extended Activities of Daily Living Index (Eadl) is made up of 22 items divided into 4 sections, each item is scored from 0 to 3 points. Investigators use Eadl index mobility subdomain to assess the community participation level of participants.	Change from baseline at 5 months
Other	Activities-specific Balance confidence	The Activities-specific Balance confidence (ABS) scale is a questionnaire developed to assess older individual's balance confidence in performing daily activities. ABC scale consists of a wide continuum of less and more challenging daily activities. The ABS scale has 16 items, representing daily activities. Participants are asked to answer, with a score from 0% (not confident at all) to 100% (completely confident) in increments of 10%, how confident they are in performing each activity. The average score obtained is an indication on balance confidence.	Change from baseline at 5 months
Primary	Modified Emory Functional Ambulation Profile(mEFAP)	The mEFAP is a clinical test that measures the time to ambulate through five common environmental terrains with or without an assistive device .It has been demonstrated to have a high inter-rater and test-retest reliability as a measure of gait capacity and functional ambulation in the post stroke patient population. The mEFAP comprises five timed tasks: (1) a 5-m walk on a hard floor; (2) a 5-m walk on a carpeted surface; (3) to rise from a chair, a 3-m walk, and return to a seated position (the timed "up-and-go" test); (4) a standardized obstacle course; and (5) to ascent and descent five stairs. The five timed sub scores will be adjusted by a multiplier for any necessary assistive device and then add together to derive a composite score.	Change from baseline at 5 months
Secondary	Modified Ashworth scale	Spasticity of skeletal muscle in lower extremity was evaluated by using the MAS scale. It uses a 8-point scale (0, 1, 1+,2, 2+, 3, 3+, 4) to score the average resistance to passive movement for each join with higher score indicating higher spasticity. The MAS has shown good reliability and validity. Investigators assessed the MAS of knee flexor/ extensor, ankle dorsiflexor/planta flexor in sitting position. The maximum of MAS scale is 4, and the minimum is 0. The higher scores mean a worse outcome.	Change from baseline at 5 months
Secondary	Medical Research Council scale	The MRC scale is a reliable measurement which ranges from 0 (no contraction) to 5 (normal power). Total scale combines all range and computes average scores, the higher scores mean a better outcome. The MRC scale will be used to examine the muscle strength of the affected hip flexion, knee flexion, knee extension, and ankle dorsiflexion in both sitting and standing positions.	Change from baseline at 5 months
Secondary	Pendulum test	Investigators use Pendulum test to evaluate the spasticity of knee extensors and record data of gyrometer deg?accelerometer deg?magnet deg. The pendular parameters (first swing excursion and relaxation index) will be extracted from an electro goniometer with 2 sensors, 15 cm above and below lateral femoral epicondyle respectively. Previous study showed the pendular parameters can provide additional ambulatory information, as complementary to the MAS .	Change from baseline at 5 months
Secondary	Berg Balance Scale	The BBS is a 14-item scale, which is widely used to assess balance disorders in people with stroke, each item is scored from 0 to 4 points. The reliability and validity of the BBS are well established. Investigators used BBS for balance function assessment. The higher scores mean a better outcome.	Change from baseline at 5 months
Secondary	Six-Minute Walking Test	The 6MWT is commonly used to assess patients' cardiovascular or respiratory problems and is regarded as a submaximal test of aerobic capacity. Investigators will use 6MWT to assess walking endurance. It is now commonly used in stroke patients and is highly reliable in this group. The maximum distance covered on a 20-m walkway in 6 mins is recorded.	Change from baseline at 5 months
Secondary	Isometric strength	Isometric strength was measured using the Biodex System 3a. Investigators use to test consisting of three knee flexion/extension isometric contractions at 30°, 45°, 90° knee flexion, and record data of isometric peak torque (Nm/kg).Five-second maximal voluntary isometric contraction (MVIC) trials were performed ten times. A rest of 15s was given between contractions for each trial, and the interval between two angles was approximately 2 min. Isometric peak torque (Nm/kg) was calculated as the highest value from the filtered torque data during each MVIC, which was normalized by the body mass. The isometric peak torque (Nm) was obtained from the Biodex System 3 software for both flexion and extension.	Change from baseline at 5 months