Spastic GaitNCT06070987

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

A study testing BoNT-A injections, RF BoNT-A injection in first period and robot therapy and RF BoNT-A injection in second period and robot therapy in people with Spastic Gait and Spastic, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Spastic Gait, Spastic
What is being tested?: BoNT-A injections, RF BoNT-A injection in first period and robot therapy and RF BoNT-A injection in second period and robot therapy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteTaiwan
Study dates: 1 Aug 2023to 31 Jul 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Kaohsiung City, Kaohsiung, 833

Other trials in Taiwan

About this study

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

Read the 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.

Conditions: Spastic Gait, Spastic
Being tested: BoNT-A injections, RF BoNT-A injection in first period and robot therapy, RF BoNT-A injection in second period and robot therapy
Keywords: Spasticity, Stroke rehabilitation, Botulinum toxin type A injection, Robot, Knee
Medical subject headings: Gait Disorders, Neurologic, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BoNT-A injectionsProcedure or surgery
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.
RF BoNT-A injection in first period and robot therapyOther
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. After a 3-month washout period crossover to none RF BoNT-A injection, and received second round of robot therapy.
RF BoNT-A injection in second period and robot therapyOther
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 (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. After a 3-month washout period crossover to RF BoNT-A injection, and received second round of robot therapy.

Study groups in NCT06070987
Study group	Role	What they receive
RF BoNT-A injection in first period and robot therapy	Experimental	Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. Receives: Procedure: BoNT-A injections; Other: RF BoNT-A injection in first period and robot therapy
RF BoNT-A injection in second period and robot therapy	Experimental	Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks. Receives: Procedure: BoNT-A injections; Other: RF BoNT-A injection in second period and robot therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage.
We calculate the relative change by subtracting the initial value from the final value and then dividing the answer by the absolute value of the initial number. (relative change = (post - baseline)/ baseline ×100%) 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 of 1 meter, 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.
Measured: Relative change from baseline at 5 months
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage.
A cyclogram is used to represent the functional relationship between joints during a full gait cycle, and is constructed by plotting two angles on the X-Y plane (the alteration of the hip and knee joint). It has several types of clinically relevant parameters, such as ROM of the joints, the cyclogram perimeter, the cyclogram area. And we can also compare the different between affected and unaffected side by looking at the cyclogram orientation, the trend symmetry, and the square root of the sum of squared deviation (A value of 0 indicates greater symmetry and coordination)
Measured: Relative change from baseline at 5 months

Secondary outcomes (7)

Modified Emory Functional Ambulation Profile(mEFAP)
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage.
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.
Measured: Relative change from baseline at 5 months
Modified Ashworth Scale
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage.
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.
Measured: Relative change from baseline at 5 months
Medical Research Council Scale
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage.
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. Select an appropriate testing posture based on the client's abilities.(If the client cannot be assessed in a standing position, use a sitting position instead, but it would result in a lower score.)
Measured: Relative change from baseline at 5 months
Pendulum Test
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage.
The pendulum test was performed to assess spasticity of the knee extensors. During each trial, inertial measurement unit (IMU) data were recorded, including angular velocity from the gyroscope, linear acceleration from the accelerometer, and magnetic field from the magnetometer. Pendular parameters (first swing excursion and relaxation index) were derived from knee angle trajectories measured using an electrogoniometer. The proximal and distal sensor endblocks were secured 15 cm above and 15 cm below the lateral femoral epicondyle, respectively. The two sensor were used to obtain one integrated knee-joint angle signal based on the relative motion between segments, rather than two separate outputs. Previous study showed the pendular parameters can provide additional ambulatory information, as complementary to the MAS .
Measured: Relative change from baseline at 5 months
Berg Balance Scale
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage.
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.
Measured: Relative change from baseline at 5 months
Six-Minute Walking Test
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage.
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.
Measured: Relative change from baseline at 5 months
Isometric Strength
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage.
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.
Measured: Relative change from baseline at 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202331 Jul 2025

First posted6 Oct 2023
Study start1 Aug 2023
Primary completion31 Jul 2025
Study completion31 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (68)Papers the sponsor has linked to this study.
Other trials for Spastic GaitStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06070987
Sponsor's protocol ID: NMRPG8N0051
Status last verified: Feb 2025
First submitted: 13 Sep 2023
Last updated: 20 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Baer HR, Wolf SL. Modified emory functional ambulation profile: an outcome measure for the rehabilitation of poststroke gait dysfunction. Stroke. 2001 Apr;32(4):973-9. doi: 10.1161/01.str.32.4.973.
PubMed 11283399
Beckerman H, Becher J, Lankhorst GJ, Verbeek AL. Walking ability of stroke patients: efficacy of tibial nerve blocking and a polypropylene ankle-foot orthosis. Arch Phys Med Rehabil. 1996 Nov;77(11):1144-51. doi: 10.1016/s0003-9993(96)90138-0.
PubMed 8931526
Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.
PubMed 1468055
Bittner V, Weiner DH, Yusuf S, Rogers WJ, McIntyre KM, Bangdiwala SI, Kronenberg MW, Kostis JB, Kohn RM, Guillotte M, et al. Prediction of mortality and morbidity with a 6-minute walk test in patients with left ventricular dysfunction. SOLVD Investigators. JAMA. 1993 Oct 13;270(14):1702-7.
PubMed 8411500
Bleyenheuft C, Cockx S, Caty G, Stoquart G, Lejeune T, Detrembleur C. The effect of botulinum toxin injections on gait control in spastic stroke patients presenting with a stiff-knee gait. Gait Posture. 2009 Aug;30(2):168-72. doi: 10.1016/j.gaitpost.2009.04.003. Epub 2009 May 12.
PubMed 19442523
Blum L, Korner-Bitensky N. Usefulness of the Berg Balance Scale in stroke rehabilitation: a systematic review. Phys Ther. 2008 May;88(5):559-66. doi: 10.2522/ptj.20070205. Epub 2008 Feb 21.
PubMed 18292215
Brewer BR, McDowell SK, Worthen-Chaudhari LC. Poststroke upper extremity rehabilitation: a review of robotic systems and clinical results. Top Stroke Rehabil. 2007 Nov-Dec;14(6):22-44. doi: 10.1310/tsr1406-22.
PubMed 18174114
Bruni MF, Melegari C, De Cola MC, Bramanti A, Bramanti P, Calabro RS. What does best evidence tell us about robotic gait rehabilitation in stroke patients: A systematic review and meta-analysis. J Clin Neurosci. 2018 Feb;48:11-17. doi: 10.1016/j.jocn.2017.10.048. Epub 2017 Dec 6.
PubMed 29208476
Calabro RS, Naro A, Russo M, Bramanti P, Carioti L, Balletta T, Buda A, Manuli A, Filoni S, Bramanti A. Shaping neuroplasticity by using powered exoskeletons in patients with stroke: a randomized clinical trial. J Neuroeng Rehabil. 2018 Apr 25;15(1):35. doi: 10.1186/s12984-018-0377-8.
PubMed 29695280
Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of simultaneous botulinum toxin injections into several muscles on impairment, activity, participation, and quality of life among stroke patients presenting with a stiff knee gait. Stroke. 2008 Oct;39(10):2803-8. doi: 10.1161/STROKEAHA.108.516153. Epub 2008 Jul 17.
PubMed 18635841
Chang WH, Kim YH. Robot-assisted Therapy in Stroke Rehabilitation. J Stroke. 2013 Sep;15(3):174-81. doi: 10.5853/jos.2013.15.3.174. Epub 2013 Sep 27.
PubMed 24396811
Chen B, Ma H, Qin LY, Gao F, Chan KM, Law SW, Qin L, Liao WH. Recent developments and challenges of lower extremity exoskeletons. J Orthop Translat. 2015 Oct 17;5:26-37. doi: 10.1016/j.jot.2015.09.007. eCollection 2016 Apr.
PubMed 30035072
Chou MY, Nishita Y, Nakagawa T, Tange C, Tomida M, Shimokata H, Otsuka R, Chen LK, Arai H. Role of gait speed and grip strength in predicting 10-year cognitive decline among community-dwelling older people. BMC Geriatr. 2019 Jul 5;19(1):186. doi: 10.1186/s12877-019-1199-7.
PubMed 31277579
Council, M. R. (1976). Aids to the examination of the peripheral nervous system. HM Stationery Office.
Delp SL, Anderson FC, Arnold AS, Loan P, Habib A, John CT, Guendelman E, Thelen DG. OpenSim: open-source software to create and analyze dynamic simulations of movement. IEEE Trans Biomed Eng. 2007 Nov;54(11):1940-50. doi: 10.1109/TBME.2007.901024.
PubMed 18018689

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Spastic Gait trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06070987
Acronym / sponsor ID: NMRPG8N0051
Conditions: Spastic Gait, Spastic
Keywords: Spasticity, Stroke rehabilitation, Botulinum toxin type A injection, Robot, Knee
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Chang Gung Memorial HospitalUniversity, hospital or other
Study start: 1 Aug 2023 (actual)
Primary completion: 31 Jul 2025 (actual)
Study completion: 31 Jul 2025 (actual)
First posted: 6 Oct 2023 (actual)
Results: Posted 20 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
RF BoNT-A injection in first period and robot therapy	Experimental	Procedure: BoNT-A injections, Other: RF BoNT-A injection in first period and robot therapyTraining session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
RF BoNT-A injection in second period and robot therapy	Experimental	Procedure: BoNT-A injections, Other: RF BoNT-A injection in second period and robot therapyTraining session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BoNT-A injectionsBotox 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.	Procedure or surgery	RF BoNT-A injection in first period and robot therapy, RF BoNT-A injection in second period and robot therapy
RF BoNT-A injection in first period and robot therapyWearable 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. After a 3-month washout period crossover to none RF BoNT-A injection, and received second round of robot therapy.	Other	RF BoNT-A injection in first period and robot therapy
RF BoNT-A injection in second period and robot therapyWearable 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 (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. After a 3-month washout period crossover to RF BoNT-A injection, and received second round of robot therapy.	Other	RF BoNT-A injection in second period and robot therapy

Primary outcome

Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Time frame: Relative change from baseline at 5 months
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. We calculate the relative change by subtracting the initial value from the final value and then dividing the answer by the absolute value of the initial number. (relative change = (post - baseline)/ baseline ×100%) 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 of 1 meter, 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.
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
Time frame: Relative change from baseline at 5 months
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. A cyclogram is used to represent the functional relationship between joints during a full gait cycle, and is constructed by plotting two angles on the X-Y plane (the alteration of the hip and knee joint). It has several types of clinically relevant parameters, such as ROM of the joints, the cyclogram perimeter, the cyclogram area. And we can also compare the different between affected and unaffected side by looking at the cyclogram orientation, the trend symmetry, and the square root of the sum of squared deviation (A value of 0 indicates greater symmetry and coordination)

7 secondary outcomes

Modified Emory Functional Ambulation Profile(mEFAP)
Time frame: Relative change from baseline at 5 months
Modified Ashworth Scale
Time frame: Relative change from baseline at 5 months
Medical Research Council Scale
Time frame: Relative change from baseline at 5 months
Pendulum Test
Time frame: Relative change from baseline at 5 months
Berg Balance Scale
Time frame: Relative change from baseline at 5 months
Six-Minute Walking Test
Time frame: Relative change from baseline at 5 months
Isometric Strength
Time frame: Relative change from baseline at 5 months

Results and safety

Results posted to the registry on 20 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RF BoNT-A Injection Plus Robot Therapy Then Robot Therapy Only	15	12
Robot Therapy Only Then RF BoNT-A Injection Plus Robot Therapy	15	13

Primary outcome: Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)

Time frame: Relative change from baseline at 5 months. Mean (Standard Deviation). Unit: percentage (relative change)

Measure	RF BoNT-A Injection and Robot Therapy n = 21	None RF BoNT-A Injection and Robot Therapy n = 20
Hip flexion / extension angle (affected side)	9 (14)	-2 (22)
Hip flexion / extension angle (unaffected side)	9 (26)	2 (15)
Knee flexion / extension angle (affected side)	38 (53)	-3 (33)
Knee flexion / extension angle (unaffected side)	10 (14)	0.4 (12)
Ankle dorsiflexion / plantar flexion angle (affected side)	10 (31)	6 (43)
Ankle dorsiflexion / plantar flexion angle (unaffected side)	7 (31)	-1 (16)
Maximum Mean Speed	13 (12)	15 (40)
Variability of speed on steady state (rms)	3 (27)	14 (37)

Population analysed: We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates.

Primary outcome: Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation

Time frame: Relative change from baseline at 5 months. Mean (Standard Deviation). Unit: percentage (relative change)

Measure	RF BoNT-A Injection and Robot Therapy n = 21	None RF BoNT-A Injection and Robot Therapy n = 20
Peak knee flexion angle (affected side)	11 (25)	16 (36)
Peak knee flexion angle (unaffected side)	6 (9)	5 (10)
Cyclogram orientation of knee joints	-21 (40)	128 (431)
Cyclogram orientation of hip joints	-12 (54)	28 (93)
Trend symmetry of knee joints	-7 (60)	42 (81)
Trend symmetry of hip joints	34 (121)	88 (270)
Cyclogram perimeters (affected side)	25 (48)	0.5 (28)
Cyclogram perimeters (unaffected side)	6 (11)	5 (17)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RF BoNT-A Injection and Robot Therapy	0 of 0	0 of 0	0
None RF BoNT-A Injection and Robot Therapy	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11283399Baer HR, Wolf SL. Modified emory functional ambulation profile: an outcome measure for the rehabilitation of poststroke gait dysfunction. Stroke. 2001 Apr;32(4):973-9. doi: 10.1161/01.str.32.4.973.
Background: PubMed 8931526Beckerman H, Becher J, Lankhorst GJ, Verbeek AL. Walking ability of stroke patients: efficacy of tibial nerve blocking and a polypropylene ankle-foot orthosis. Arch Phys Med Rehabil. 1996 Nov;77(11):1144-51. doi: 10.1016/s0003-9993(96)90138-0.
Background: PubMed 1468055Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.
Background: PubMed 8411500Bittner V, Weiner DH, Yusuf S, Rogers WJ, McIntyre KM, Bangdiwala SI, Kronenberg MW, Kostis JB, Kohn RM, Guillotte M, et al. Prediction of mortality and morbidity with a 6-minute walk test in patients with left ventricular dysfunction. SOLVD Investigators. JAMA. 1993 Oct 13;270(14):1702-7.
Background: PubMed 19442523Bleyenheuft C, Cockx S, Caty G, Stoquart G, Lejeune T, Detrembleur C. The effect of botulinum toxin injections on gait control in spastic stroke patients presenting with a stiff-knee gait. Gait Posture. 2009 Aug;30(2):168-72. doi: 10.1016/j.gaitpost.2009.04.003. Epub 2009 May 12.
Background: PubMed 18292215Blum L, Korner-Bitensky N. Usefulness of the Berg Balance Scale in stroke rehabilitation: a systematic review. Phys Ther. 2008 May;88(5):559-66. doi: 10.2522/ptj.20070205. Epub 2008 Feb 21.
Background: PubMed 18174114Brewer BR, McDowell SK, Worthen-Chaudhari LC. Poststroke upper extremity rehabilitation: a review of robotic systems and clinical results. Top Stroke Rehabil. 2007 Nov-Dec;14(6):22-44. doi: 10.1310/tsr1406-22.
Background: PubMed 29208476Bruni MF, Melegari C, De Cola MC, Bramanti A, Bramanti P, Calabro RS. What does best evidence tell us about robotic gait rehabilitation in stroke patients: A systematic review and meta-analysis. J Clin Neurosci. 2018 Feb;48:11-17. doi: 10.1016/j.jocn.2017.10.048. Epub 2017 Dec 6.
Background: PubMed 29695280Calabro RS, Naro A, Russo M, Bramanti P, Carioti L, Balletta T, Buda A, Manuli A, Filoni S, Bramanti A. Shaping neuroplasticity by using powered exoskeletons in patients with stroke: a randomized clinical trial. J Neuroeng Rehabil. 2018 Apr 25;15(1):35. doi: 10.1186/s12984-018-0377-8.
Background: PubMed 18635841Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of simultaneous botulinum toxin injections into several muscles on impairment, activity, participation, and quality of life among stroke patients presenting with a stiff knee gait. Stroke. 2008 Oct;39(10):2803-8. doi: 10.1161/STROKEAHA.108.516153. Epub 2008 Jul 17.
Background: PubMed 24396811Chang WH, Kim YH. Robot-assisted Therapy in Stroke Rehabilitation. J Stroke. 2013 Sep;15(3):174-81. doi: 10.5853/jos.2013.15.3.174. Epub 2013 Sep 27.
Background: PubMed 30035072Chen B, Ma H, Qin LY, Gao F, Chan KM, Law SW, Qin L, Liao WH. Recent developments and challenges of lower extremity exoskeletons. J Orthop Translat. 2015 Oct 17;5:26-37. doi: 10.1016/j.jot.2015.09.007. eCollection 2016 Apr.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hung Jen-Wen principal investigator

Chang Gung Memorial Hospital-Kaohsiung Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length) (time frame: Relative change from baseline at 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06070987, which also lists 68 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.