Exoskeleton Robotic Assisted Gait Training in Spastic Stroke Post Botulinum Toxin a Injection
- Conditions
- Spastic GaitSpastic
- Interventions
- Procedure: BoNT-A injectionsOther: None BoNT-A injection and robot therapyOther: BoNT-A injection and robot therapy
- Registration Number
- NCT06070987
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BoNT-A injection and robot therapy BoNT-A injection and robot therapy Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. BoNT-A injection and robot therapy BoNT-A injections Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. None BoNT-A injection and robot therapy None BoNT-A injection and robot therapy Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
- Primary Outcome Measures
Name Time Method Modified Emory Functional Ambulation Profile(mEFAP) Change from baseline at 5 months 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
Name Time Method Modified Ashworth scale Change from baseline at 5 months 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.
Pendulum test Change from baseline at 5 months 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 .
Isometric strength Change from baseline at 5 months 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.
Medical Research Council scale Change from baseline at 5 months 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.
Berg Balance Scale Change from baseline at 5 months 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 Change from baseline at 5 months 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.
Trial Locations
- Locations (1)
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
🇨🇳Kaohsiung, Taiwan