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

NCT06070987 | Completed Results

• 1 other identifier: NMRPG8N0051
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Gait; Spastic

Keywords

Spasticity; Stroke rehabilitation; Botulinum toxin type A injection; Robot; Knee

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  Relative change from baseline at 5 months

Secondary Outcomes (7)

• Modified Emory Functional Ambulation Profile(mEFAP)

  Relative change from baseline at 5 months

• Modified Ashworth Scale

  Relative change from baseline at 5 months

• Medical Research Council Scale

  Relative change from baseline at 5 months

• Pendulum Test

  Relative change from baseline at 5 months

• Berg Balance Scale

  Relative change from baseline at 5 months

Other Outcomes (2)

• Nottingham Extended Activities of Daily Living Index

  Relative change from baseline at 5 months

• Activities-specific Balance Confidence

  Relative change from baseline at 5 months

Study Arms (2)

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.

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.

Procedure: BoNT-A injections; Other: RF BoNT-A injection in second period and robot therapy

Interventions

BoNT-A injections PROCEDURE

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 therapy; RF BoNT-A injection in second period and robot therapy

RF BoNT-A injection in first period and robot therapy OTHER

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 first period and robot therapy

RF BoNT-A injection in second period and robot therapy OTHER

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.

RF BoNT-A injection in second period and robot therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

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

Kaohsiung City, Kaohsiung, 833, Taiwan

Location

Related Publications (68)

• 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.

  PMID: 11283399 BACKGROUND

• 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.

  PMID: 8931526 BACKGROUND

• 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.

  PMID: 1468055 BACKGROUND

• 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.

  PMID: 8411500 BACKGROUND

• 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.

  PMID: 19442523 BACKGROUND

• 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.

  PMID: 18292215 BACKGROUND

• 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.

  PMID: 18174114 BACKGROUND

• 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.

  PMID: 29208476 BACKGROUND

• 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.

  PMID: 29695280 BACKGROUND

• 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.

  PMID: 18635841 BACKGROUND

• 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.

  PMID: 24396811 BACKGROUND

• 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.

  PMID: 30035072 BACKGROUND

• 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.

  PMID: 31277579 BACKGROUND

• Council, M. R. (1976). Aids to the examination of the peripheral nervous system. HM Stationery Office.

  BACKGROUND

• 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.

  PMID: 18018689 BACKGROUND

• Dobkin BH. Progressive Staging of Pilot Studies to Improve Phase III Trials for Motor Interventions. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):197-206. doi: 10.1177/1545968309331863.

  PMID: 19240197 BACKGROUND

• Eng JJ, Tang PF. Gait training strategies to optimize walking ability in people with stroke: a synthesis of the evidence. Expert Rev Neurother. 2007 Oct;7(10):1417-36. doi: 10.1586/14737175.7.10.1417.

  PMID: 17939776 BACKGROUND

• Erbil D, Tugba G, Murat TH, Melike A, Merve A, Cagla K, Mehmetali CC, Akay O, Nigar D. Effects of robot-assisted gait training in chronic stroke patients treated by botulinum toxin-a: A pivotal study. Physiother Res Int. 2018 Jul;23(3):e1718. doi: 10.1002/pri.1718. Epub 2018 May 28.

  PMID: 29808523 BACKGROUND

• Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.

  PMID: 15788341 BACKGROUND

• Gregson JM, Leathley MJ, Moore AP, Smith TL, Sharma AK, Watkins CL. Reliability of measurements of muscle tone and muscle power in stroke patients. Age Ageing. 2000 May;29(3):223-8. doi: 10.1093/ageing/29.3.223.

  PMID: 10855904 BACKGROUND

• Hinderer SR, Gupta S. Functional outcome measures to assess interventions for spasticity. Arch Phys Med Rehabil. 1996 Oct;77(10):1083-9. doi: 10.1016/s0003-9993(96)90073-8.

  PMID: 8857891 BACKGROUND

• Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984 Jan;64(1):35-40. doi: 10.1093/ptj/64.1.35.

  PMID: 6691052 BACKGROUND

• Huang JJ, Pei YC, Chen YY, Tseng SS, Hung JW. Bilateral Sensorimotor Cortical Communication Modulated by Multiple Hand Training in Stroke Participants: A Single Training Session Pilot Study. Bioengineering (Basel). 2022 Nov 24;9(12):727. doi: 10.3390/bioengineering9120727.

  PMID: 36550934 BACKGROUND

• Huang YD, Li W, Chou YL, Hung ES, Kang JH. Pendulum test in chronic hemiplegic stroke population: additional ambulatory information beyond spasticity. Sci Rep. 2021 Jul 20;11(1):14769. doi: 10.1038/s41598-021-94108-5.

  PMID: 34285276 BACKGROUND

• Hung JW, Chen YW, Chen YJ, Pong YP, Wu WC, Chang KC, Wu CY. The Effects of Distributed vs. Condensed Schedule for Robot-Assisted Training with Botulinum Toxin A Injection for Spastic Upper Limbs in Chronic Post-Stroke Subjects. Toxins (Basel). 2021 Aug 1;13(8):539. doi: 10.3390/toxins13080539.

  PMID: 34437410 BACKGROUND

• Hung JW, Yen CL, Chang KC, Chiang WC, Chuang IC, Pong YP, Wu WC, Wu CY. A Pilot Randomized Controlled Trial of Botulinum Toxin Treatment Combined with Robot-Assisted Therapy, Mirror Therapy, or Active Control Treatment in Patients with Spasticity Following Stroke. Toxins (Basel). 2022 Jun 17;14(6):415. doi: 10.3390/toxins14060415.

  PMID: 35737076 BACKGROUND

• Katrak PH, Cole AM, Poulos CJ, McCauley JC. Objective assessment of spasticity, strength, and function with early exhibition of dantrolene sodium after cerebrovascular accident: a randomized double-blind study. Arch Phys Med Rehabil. 1992 Jan;73(1):4-9.

  PMID: 1729971 BACKGROUND

• Kerrigan DC, Bang MS, Burke DT. An algorithm to assess stiff-legged gait in traumatic brain injury. J Head Trauma Rehabil. 1999 Apr;14(2):136-45. doi: 10.1097/00001199-199904000-00004.

  PMID: 10191372 BACKGROUND

• Kerrigan DC, Burke DT, Nieto TJ, Riley PO. Can toe-walking contribute to stiff-legged gait? Am J Phys Med Rehabil. 2001 Jan;80(1):33-7. doi: 10.1097/00002060-200101000-00009.

  PMID: 11138952 BACKGROUND

• Kerrigan DC, Karvosky ME, Riley PO. Spastic paretic stiff-legged gait: joint kinetics. Am J Phys Med Rehabil. 2001 Apr;80(4):244-9. doi: 10.1097/00002060-200104000-00002.

  PMID: 11277129 BACKGROUND

• Casey Kerrigan D, S Roth R, Riley PO. The modelling of adult spastic paretic stiff-legged gait swing period based on actual kinematic data. Gait Posture. 1998 Mar 1;7(2):117-124. doi: 10.1016/s0966-6362(97)00040-4.

  PMID: 10200381 BACKGROUND

• Kerrigan, D. C., & Sheffler, L. R. (1995). Spastic paretic gait: an approach to evaluation and treatment. Critical Reviews™ in Physical and Rehabilitation Medicine, 7(3).

  BACKGROUND

• Kramer SF, Hung SH, Brodtmann A. The Impact of Physical Activity Before and After Stroke on Stroke Risk and Recovery: a Narrative Review. Curr Neurol Neurosci Rep. 2019 Apr 22;19(6):28. doi: 10.1007/s11910-019-0949-4.

  PMID: 31011851 BACKGROUND

• Levy J, Molteni F, Cannaviello G, Lansaman T, Roche N, Bensmail D. Does botulinum toxin treatment improve upper limb active function? Ann Phys Rehabil Med. 2019 Jul;62(4):234-240. doi: 10.1016/j.rehab.2018.05.1320. Epub 2018 Jun 28.

  PMID: 29960017 BACKGROUND

• Li S, Francisco GE. New insights into the pathophysiology of post-stroke spasticity. Front Hum Neurosci. 2015 Apr 10;9:192. doi: 10.3389/fnhum.2015.00192. eCollection 2015.

  PMID: 25914638 BACKGROUND

• Lundstrom E, Terent A, Borg J. Prevalence of disabling spasticity 1 year after first-ever stroke. Eur J Neurol. 2008 Jun;15(6):533-9. doi: 10.1111/j.1468-1331.2008.02114.x. Epub 2008 Mar 18.

  PMID: 18355307 BACKGROUND

• McGibbon CA, Sexton A, Jayaraman A, Deems-Dluhy S, Gryfe P, Novak A, Dutta T, Fabara E, Adans-Dester C, Bonato P. Evaluation of the Keeogo exoskeleton for assisting ambulatory activities in people with multiple sclerosis: an open-label, randomized, cross-over trial. J Neuroeng Rehabil. 2018 Dec 12;15(1):117. doi: 10.1186/s12984-018-0468-6.

  PMID: 30541585 BACKGROUND

• Molteni F, Gasperini G, Cannaviello G, Guanziroli E. Exoskeleton and End-Effector Robots for Upper and Lower Limbs Rehabilitation: Narrative Review. PM R. 2018 Sep;10(9 Suppl 2):S174-S188. doi: 10.1016/j.pmrj.2018.06.005.

  PMID: 30269804 BACKGROUND

• Mudge S, Stott NS. Timed walking tests correlate with daily step activity in persons with stroke. Arch Phys Med Rehabil. 2009 Feb;90(2):296-301. doi: 10.1016/j.apmr.2008.07.025.

  PMID: 19236983 BACKGROUND

• Negrini F, Gasperini G, Guanziroli E, Vitale JA, Banfi G, Molteni F. Using an Accelerometer-Based Step Counter in Post-Stroke Patients: Validation of a Low-Cost Tool. Int J Environ Res Public Health. 2020 May 2;17(9):3177. doi: 10.3390/ijerph17093177.

  PMID: 32370210 BACKGROUND

• Noonan V, Dean E. Submaximal exercise testing: clinical application and interpretation. Phys Ther. 2000 Aug;80(8):782-807.

  PMID: 10911416 BACKGROUND

• Novak AC, Olney SJ, Bagg S, Brouwer B. Gait changes following botulinum toxin A treatment in stroke. Top Stroke Rehabil. 2009 Sep-Oct;16(5):367-76. doi: 10.1310/tsr1605-367.

  PMID: 19903655 BACKGROUND

• O'Dwyer NJ, Ada L, Neilson PD. Spasticity and muscle contracture following stroke. Brain. 1996 Oct;119 ( Pt 5):1737-49. doi: 10.1093/brain/119.5.1737.

  PMID: 8931594 BACKGROUND

• Olney, S. J., & Richards, C. (1996). Hemiparetic gait following stroke. Part I: Characteristics. Gait & posture, 4(2), 136-148.

  BACKGROUND

• Perry, J. (1992). Gait Analysis. Thorofare, NJ: SLACK. In: Inc.

  BACKGROUND

• Piazza SJ, Delp SL. The influence of muscles on knee flexion during the swing phase of gait. J Biomech. 1996 Jun;29(6):723-33. doi: 10.1016/0021-9290(95)00144-1.

  PMID: 9147969 BACKGROUND

• Picelli A, Bacciga M, Melotti C, LA Marchina E, Verzini E, Ferrari F, Pontillo A, Corradi J, Tamburin S, Saltuari L, Corradini C, Waldner A, Smania N. Combined effects of robot-assisted gait training and botulinum toxin type A on spastic equinus foot in patients with chronic stroke: a pilot, single blind, randomized controlled trial. Eur J Phys Rehabil Med. 2016 Dec;52(6):759-766. Epub 2016 Apr 21.

  PMID: 27098300 BACKGROUND

• Picelli A, Dambruoso F, Bronzato M, Barausse M, Gandolfi M, Smania N. Efficacy of therapeutic ultrasound and transcutaneous electrical nerve stimulation compared with botulinum toxin type A in the treatment of spastic equinus in adults with chronic stroke: a pilot randomized controlled trial. Top Stroke Rehabil. 2014;21 Suppl 1:S8-16. doi: 10.1310/tsr21S1-S8.

  PMID: 24722047 BACKGROUND

• Portney, L. G., & Watkins, M. P. (2009). Foundations of clinical research: applications to practice (Vol. 892). Pearson/Prentice Hall Upper Saddle River, NJ.

  BACKGROUND

• Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.

  PMID: 7814786 BACKGROUND

• Riley PO, Kerrigan DC. Torque action of two-joint muscles in the swing period of stiff-legged gait: a forward dynamic model analysis. J Biomech. 1998 Sep;31(9):835-40. doi: 10.1016/s0021-9290(98)00107-9.

  PMID: 9802784 BACKGROUND

• Robertson JV, Pradon D, Bensmail D, Fermanian C, Bussel B, Roche N. Relevance of botulinum toxin injection and nerve block of rectus femoris to kinematic and functional parameters of stiff knee gait in hemiplegic adults. Gait Posture. 2009 Jan;29(1):108-12. doi: 10.1016/j.gaitpost.2008.07.005. Epub 2008 Sep 3.

  PMID: 18771925 BACKGROUND

• Roche N, Boudarham J, Hardy A, Bonnyaud C, Bensmail B. Use of gait parameters to predict the effectiveness of botulinum toxin injection in the spastic rectus femoris muscle of stroke patients with stiff knee gait. Eur J Phys Rehabil Med. 2015 Aug;51(4):361-70. Epub 2014 Sep 12.

  PMID: 25213306 BACKGROUND

• Rosales RL, Chua-Yap AS. Evidence-based systematic review on the efficacy and safety of botulinum toxin-A therapy in post-stroke spasticity. J Neural Transm (Vienna). 2008;115(4):617-23. doi: 10.1007/s00702-007-0869-3. Epub 2008 Mar 6.

  PMID: 18322637 BACKGROUND

• Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

  PMID: 3809245 BACKGROUND

• Santamato A, Micello MF, Panza F, Fortunato F, Baricich A, Cisari C, Pilotto A, Logroscino G, Fiore P, Ranieri M. Can botulinum toxin type A injection technique influence the clinical outcome of patients with post-stroke upper limb spasticity? A randomized controlled trial comparing manual needle placement and ultrasound-guided injection techniques. J Neurol Sci. 2014 Dec 15;347(1-2):39-43. doi: 10.1016/j.jns.2014.09.016. Epub 2014 Sep 19.

  PMID: 25263601 BACKGROUND

• Santamato A, Ranieri M, Solfrizzi V, Lozupone M, Vecchio M, Daniele A, Greco A, Seripa D, Logroscino G, Panza F. High doses of incobotulinumtoxinA for the treatment of post-stroke spasticity: are they safe and effective? Expert Opin Drug Metab Toxicol. 2016 Aug;12(8):843-6. doi: 10.1080/17425255.2016.1198318. Epub 2016 Jun 17. No abstract available.

  PMID: 27291256 BACKGROUND

• Seth A, Hicks JL, Uchida TK, Habib A, Dembia CL, Dunne JJ, Ong CF, DeMers MS, Rajagopal A, Millard M, Hamner SR, Arnold EM, Yong JR, Lakshmikanth SK, Sherman MA, Ku JP, Delp SL. OpenSim: Simulating musculoskeletal dynamics and neuromuscular control to study human and animal movement. PLoS Comput Biol. 2018 Jul 26;14(7):e1006223. doi: 10.1371/journal.pcbi.1006223. eCollection 2018 Jul.

  PMID: 30048444 BACKGROUND

• Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.

  PMID: 18164331 BACKGROUND

• Tenniglo MJ, Nederhand MJ, Prinsen EC, Nene AV, Rietman JS, Buurke JH. Effect of chemodenervation of the rectus femoris muscle in adults with a stiff knee gait due to spastic paresis: a systematic review with a meta-analysis in patients with stroke. Arch Phys Med Rehabil. 2014 Mar;95(3):576-87. doi: 10.1016/j.apmr.2013.11.008. Epub 2013 Dec 3.

  PMID: 24309072 BACKGROUND

• Tok F, Balaban B, Yasar E, Alaca R, Tan AK. The effects of onabotulinum toxin A injection into rectus femoris muscle in hemiplegic stroke patients with stiff-knee gait: a placebo-controlled, nonrandomized trial. Am J Phys Med Rehabil. 2012 Apr;91(4):321-6. doi: 10.1097/PHM.0b013e3182465feb.

  PMID: 22311056 BACKGROUND

• Trompetto C, Marinelli L, Mori L, Cossu E, Zilioli R, Simonini M, Abbruzzese G, Baratto L. Postactivation depression changes after robotic-assisted gait training in hemiplegic stroke patients. Gait Posture. 2013 Sep;38(4):729-33. doi: 10.1016/j.gaitpost.2013.03.011. Epub 2013 Apr 6.

  PMID: 23570893 BACKGROUND

• Tsai RC, Lin KN, Wang HJ, Liu HC. Evaluating the uses of the total score and the domain scores in the Cognitive Abilities Screening Instrument, Chinese version (CASI C-2.0): results of confirmatory factor analysis. Int Psychogeriatr. 2007 Dec;19(6):1051-63. doi: 10.1017/S1041610207005327. Epub 2007 Apr 23.

  PMID: 17451615 BACKGROUND

• Waters RL, Garland DE, Perry J, Habig T, Slabaugh P. Stiff-legged gait in hemiplegia: surgical correction. J Bone Joint Surg Am. 1979 Sep;61(6A):927-33.

  PMID: 479242 BACKGROUND

• Welmer AK, von Arbin M, Widen Holmqvist L, Sommerfeld DK. Spasticity and its association with functioning and health-related quality of life 18 months after stroke. Cerebrovasc Dis. 2006;21(4):247-53. doi: 10.1159/000091222. Epub 2006 Jan 27.

  PMID: 16446538 BACKGROUND

• Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013 Jan 15;80(3 Suppl 2):S13-9. doi: 10.1212/WNL.0b013e3182762448.

  PMID: 23319481 BACKGROUND

• Wissel J, Verrier M, Simpson DM, Charles D, Guinto P, Papapetropoulos S, Sunnerhagen KS. Post-stroke spasticity: predictors of early development and considerations for therapeutic intervention. PM R. 2015 Jan;7(1):60-7. doi: 10.1016/j.pmrj.2014.08.946. Epub 2014 Aug 27.

  PMID: 25171879 BACKGROUND

• Yelnik A, Albert T, Bonan I, Laffont I. A clinical guide to assess the role of lower limb extensor overactivity in hemiplegic gait disorders. Stroke. 1999 Mar;30(3):580-5. doi: 10.1161/01.str.30.3.580.

  PMID: 10066855 BACKGROUND

MeSH Terms

Conditions

Gait Disorders, Neurologic; Muscle Spasticity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Results Point of Contact

• Title: Jen-Wen Hung, MD
• Organization: Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

hung0702@cgmh.org.tw

+886975056689

Study Officials

• Hung Jen-Wen

  Chang Gung Memorial Hospital-Kaohsiung Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: October 6, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 20, 2026
• Results First Posted: January 20, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)