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

Primary Purpose

Spastic Gait, Spastic

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
BoNT-A injections
BoNT-A injection and robot therapy
None BoNT-A injection and robot therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Gait focused on measuring Spasticity, Stroke rehabilitation, Botulinum toxin type A injection, Robot, Knee

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, TaiwanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BoNT-A injection and robot therapy

None BoNT-A injection and robot therapy

Arm Description

Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.

Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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 .
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.
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.

Full Information

First Posted
September 13, 2023
Last Updated
October 2, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06070987
Brief Title
Exoskeleton Robotic Assisted Gait Training in Spastic Stroke Post Botulinum Toxin A Injection
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Gait, Spastic
Keywords
Spasticity, Stroke rehabilitation, Botulinum toxin type A injection, Robot, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
There will be a research code representing patients' identity, this code will not show patients' name, social security number, and home address. For the results of patients' visit and the diagnosis, the study moderator will maintain a confidential attitude and be careful to maintain patients' privacy.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BoNT-A injection and robot therapy
Arm Type
Experimental
Arm Description
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
Arm Title
None BoNT-A injection and robot therapy
Arm Type
Experimental
Arm Description
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
Intervention Type
Procedure
Intervention Name(s)
BoNT-A injections
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
BoNT-A injection and robot therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
None BoNT-A injection and robot therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Emory Functional Ambulation Profile(mEFAP)
Description
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.
Time Frame
Change from baseline at 5 months
Secondary Outcome Measure Information:
Title
Modified Ashworth scale
Description
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.
Time Frame
Change from baseline at 5 months
Title
Medical Research Council scale
Description
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.
Time Frame
Change from baseline at 5 months
Title
Pendulum test
Description
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 .
Time Frame
Change from baseline at 5 months
Title
Berg Balance Scale
Description
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.
Time Frame
Change from baseline at 5 months
Title
Six-Minute Walking Test
Description
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.
Time Frame
Change from baseline at 5 months
Other Pre-specified Outcome Measures:
Title
Kinematic analysis
Description
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.
Time Frame
Change from baseline at 5 months
Title
Gait Assessment and Intervention Tool
Description
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.
Time Frame
Change from baseline at 5 months
Title
Nottingham Extended Activities of Daily Living Index
Description
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.
Time Frame
Change from baseline at 5 months
Title
Activities-specific Balance confidence
Description
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.
Time Frame
Change from baseline at 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung Jen-Wen
Phone
+886975056689
Email
hung0702@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung Jen-Wen
Organizational Affiliation
Chang Gung Memorial Hospital-Kaohsiung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung Jen-Wen
Phone
+886975056689
Email
hung0702@cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No
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Exoskeleton Robotic Assisted Gait Training in Spastic Stroke Post Botulinum Toxin A Injection

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