Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06070987
Other study ID # NMRPG8N0051
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.


Read more »

Study Design


Intervention

Read more »

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, 

References & Publications (68)

See more »

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
See also
  Status Clinical Trial Phase
Completed NCT03908801 - Evaluation of Specialized Water Dance Intervention N/A
Completed NCT05596513 - Motor Learning Approaches From Working on a Vertical Surface in Hemiplegic Children's Upper Limb Motor Skills N/A
Recruiting NCT06214975 - EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE 2) N/A
Completed NCT05636241 - Whole Body Vibration in Children With Cerebral Palsy N/A
Recruiting NCT05912595 - EXOPULSE Mollii Suit, Spasticity, Muscular Oxygenation & Multiple Sclerosis (ENNOX 2) N/A
Recruiting NCT05857280 - EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis (EXOSEP 2) N/A
Completed NCT05231538 - Neurodevelopmental Therapy for Spastic Cerebral Palsy N/A
Completed NCT04859673 - Influence of Radial Extracorpeal Shock Wave in Hemiplegic Shoulder Patients N/A
Recruiting NCT05648422 - Effect of the Nutritional Support System on Neuromotor Alterations in Patients With Cerebral Palsy N/A
Not yet recruiting NCT03751306 - Aerobic Exercise and Transcranial Low Laser Therapy in Patients With Central Nervous System Injury N/A
Completed NCT04770363 - Comparison Between Unihemispheric and Bihemispheric TCDS in Subacute Ischemic Stroke Patients N/A
Completed NCT05022095 - "Validated Language Transfer of the Spinal Cord Injury-Spasticity Evaluation Tool to German Language"
Completed NCT04826900 - Wearable Robotic System and Robotic Mirror Therapy in Spastic Hemiplegia Post Botulinum Toxin Injection N/A
Completed NCT03440632 - Functional Electrical Stimulation During Walking in Cerebral Palsy N/A