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
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.
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) |
Country | Name | City | State |
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Taiwan | Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan | Kaohsiung |
Lead Sponsor | Collaborator |
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Chang Gung Memorial Hospital |
Taiwan,
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* Note: There are 68 references in all — Click here to view all references
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 |
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