Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:11 PM
Study NCT ID:
NCT07447934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Test the Effectiveness of Vibrotactile Stimulation for Lower Limb Spasticity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Given the nature of the intervention (wearable vibrotactile stimulation), full participant blinding is not feasible. However, bias will be minimized through the following:\n\nOutcome assessments (e.g., 10MWT, MAS, TUG) will be performed by blinded raters who are not involved in administering the intervention and will remain unaware of the VTS condition.\n\nParticipants will be instructed not to disclose their condition to outcome assessors. Statistical analysis will be conducted by team members who are blinded to the intervention sequence.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Aim 1 is a within-subject, counterbalanced mechanistic study evaluating neurophysiological effects of VTS applied to three anatomical sites.\n\nAim 2 is a randomized crossover trial comparing the effects of VTS during (a) static positioning and (b) dynamic gait training, each applied over 3 consecutive daily sessions with a one-week washout period between conditions.\n\nThis study includes a randomized, two-period crossover design in Aim 2, in which each participant will undergo two VTS conditions: (1) static use (resting position) and (2) dynamic use (during gait training). The order of these two intervention phases will be randomized to minimize order effects and participant-specific bias.\n\nParticipants will be randomized in a 1:1 ratio to one of two sequences:\n\nSequence A: Static VTS → Washout → Gait VTS Sequence B: Gait VTS → Washout → Static VTS'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'H-reflex amplitude Baseline (Aim 1)', 'timeFrame': 'Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1', 'description': 'Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.'}, {'measure': 'H-reflex amplitude After Intervention (Aim 1)', 'timeFrame': 'Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1', 'description': 'Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.'}, {'measure': 'Surface EMG activity of gastrocnemius/soleus Baseline (Aim 1)', 'timeFrame': 'Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1', 'description': 'Measures muscle activation patterns in gastrocnemius/soleus to evaluate VTS effects. μV amplitude; no fixed range.'}, {'measure': 'Surface EMG activity of gastrocnemius/soleus After Intervention (Aim 1)', 'timeFrame': 'Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1', 'description': 'Measures muscle activation patterns in gastrocnemius/soleus to evaluate VTS effects. μV amplitude; no fixed range.'}, {'measure': 'Modified Ashworth Scale at Screening', 'timeFrame': 'Screening Visit (-0 to 7 days prior to Aim 1 intervention)', 'description': 'Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).'}, {'measure': 'Modified Ashworth Scale at Baseline (Aim 1)', 'timeFrame': 'Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1', 'description': 'Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).'}, {'measure': 'Modified Ashworth Scale After Intervention (Aim 1)', 'timeFrame': 'Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1', 'description': 'Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).'}, {'measure': 'Modified Ashworth Scale at Baseline (Aim 2)', 'timeFrame': 'Baseline measurement immediately before intervention for 3 consecutive days for Aim 2', 'description': 'Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).'}, {'measure': 'Modified Ashworth Scale After Intervention (Aim 2)', 'timeFrame': 'Immediately after intervention for 3 consecutive days for Aim 2', 'description': 'Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).'}, {'measure': 'Passive range of motion at the ankle at Screening', 'timeFrame': 'Screening Visit (-0 to 7 days prior to Aim 1 intervention)', 'description': 'Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility'}, {'measure': 'Passive range of motion at the ankle at Baseline (Aim 1)', 'timeFrame': 'Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1', 'description': 'Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility'}, {'measure': 'Passive range of motion at the ankle After Intervention (Aim 1)', 'timeFrame': 'Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1', 'description': 'Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility'}, {'measure': 'Passive range of motion at the ankle at Baseline (Aim 2)', 'timeFrame': 'Baseline measurement immediately before intervention for 3 consecutive days for Aim 2', 'description': 'Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility'}, {'measure': 'Passive range of motion at the ankle After Intervention (Aim 2)', 'timeFrame': 'Immediately after intervention for 3 consecutive days for Aim 2', 'description': 'Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility'}, {'measure': '10 meter walk test at Baseline (Aim 2)', 'timeFrame': 'Baseline measurement immediately before intervention for 3 consecutive days for Aim 2', 'description': 'Measures gait speed over a short distance; primary measure of functional mobility. Time is in seconds; lower is better.'}, {'measure': '10 meter walk test at Baseline After Intervention (Aim 2)', 'timeFrame': 'Immediately after intervention for 3 consecutive days for Aim 2', 'description': 'Measures gait speed over a short distance; primary measure of functional mobility. Time is in seconds; lower is better.'}], 'secondaryOutcomes': [{'measure': 'Timed up and go (TUG) at Baseline (Aim 2)', 'timeFrame': 'Baseline measurement immediately before intervention for 3 consecutive days for Aim 2', 'description': 'Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better.'}, {'measure': 'Timed up and go (TUG) After Intervention (Aim 2)', 'timeFrame': 'Immediately after intervention for 3 consecutive days for Aim 2', 'description': 'Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better.'}, {'measure': 'Two minute walk test (TMWT) at Baseline (Aim 2)', 'timeFrame': 'Baseline measurement immediately before intervention for 3 consecutive days for Aim 2', 'description': 'Assesses functional mobility, balance, and fall risk. Time (s); lower is better.'}, {'measure': 'Two minute walk test (TMWT) After Intervention (Aim 2)', 'timeFrame': 'Immediately after intervention for 3 consecutive days for Aim 2', 'description': 'Assesses functional mobility, balance, and fall risk. Time (s); lower is better.'}, {'measure': 'Berg Balance Scale (BBS) at Baseline (Aim 2)', 'timeFrame': 'Baseline measurement immediately before intervention for 3 consecutive days for Aim 2', 'description': 'Evaluates balance performance using a 14-item scale. Range: 0 to 56; higher scores indicate better balance.'}, {'measure': 'Berg Balance Scale (BBS) After Intervention (Aim 2)', 'timeFrame': 'Immediately after intervention for 3 consecutive days for Aim 2', 'description': 'Evaluates balance performance using a 14-item scale. Range: 0 to 56; higher scores indicate better balance.'}, {'measure': 'Global Impression of Change Scale (GICS) at Baseline (Aim 2)', 'timeFrame': 'Baseline measurement immediately before intervention for 3 consecutive days for Aim 2', 'description': 'Self-reported measure of overall perceived improvement. Range: 1 (very much worse) to 7 (very much improved.'}, {'measure': 'Global Impression of Change Scale (GICS) After Intervention (Aim 2)', 'timeFrame': 'Immediately after intervention for 3 consecutive days for Aim 2', 'description': 'Self-reported measure of overall perceived improvement. Range: 1 (very much worse) to 7 (very much improved.'}, {'measure': 'Short form 12 (SF12) at Baseline (Aim 2)', 'timeFrame': 'Baseline measurement immediately before intervention for 3 consecutive days for Aim 2', 'description': 'Assesses health-related quality of life across physical and mental domains. Range: 0 to 100 per domain; higher is better'}, {'measure': 'Short form 12 (SF12) After Intervention (Aim 2)', 'timeFrame': 'Immediately after intervention for 3 consecutive days for Aim 2', 'description': 'Assesses health-related quality of life across physical and mental domains. Range: 0 to 100 per domain; higher is better'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['mobility', 'lower limb', 'spasticity', 'walking endurance', 'home device', 'quality of life', 'vts', 'LLS', 'gait', 'stroke'], 'conditions': ['Lower Limb Spasticity']}, 'referencesModule': {'references': [{'pmid': '30690609', 'type': 'BACKGROUND', 'citation': 'Seo NJ, Woodbury ML, Bonilha L, Ramakrishnan V, Kautz SA, Downey RJ, Dellenbach BHS, Lauer AW, Roark CM, Landers LE, Phillips SK, Vatinno AA. TheraBracelet Stimulation During Task-Practice Therapy to Improve Upper Extremity Function After Stroke: A Pilot Randomized Controlled Study. Phys Ther. 2019 Mar 1;99(3):319-328. doi: 10.1093/ptj/pzy143.'}, {'pmid': '33485371', 'type': 'BACKGROUND', 'citation': 'Seim CE, Wolf SL, Starner TE. Wearable vibrotactile stimulation for upper extremity rehabilitation in chronic stroke: clinical feasibility trial using the VTS Glove. J Neuroeng Rehabil. 2021 Jan 23;18(1):14. doi: 10.1186/s12984-021-00813-7.'}, {'pmid': '35552152', 'type': 'BACKGROUND', 'citation': 'Seim CE, Ritter B, Starner TE, Flavin K, Lansberg MG, Okamura AM. Design of a Wearable Vibrotactile Stimulation Device for Individuals With Upper-Limb Hemiparesis and Spasticity. IEEE Trans Neural Syst Rehabil Eng. 2022;30:1277-1287. doi: 10.1109/TNSRE.2022.3174808. Epub 2022 May 17.'}, {'pmid': '30914938', 'type': 'BACKGROUND', 'citation': 'Kodama K, Yasuda K, Kuznetsov NA, Hayashi Y, Iwata H. Balance Training With a Vibrotactile Biofeedback System Affects the Dynamical Structure of the Center of Pressure Trajectories in Chronic Stroke Patients. Front Hum Neurosci. 2019 Mar 12;13:84. doi: 10.3389/fnhum.2019.00084. eCollection 2019.'}, {'pmid': '29740561', 'type': 'BACKGROUND', 'citation': 'Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.'}, {'type': 'BACKGROUND', 'citation': 'Farì, G. (2023). Is there a new road to spinal cord injury rehabilitation? a case report about the effects of driving a go-kart on muscle spasticity. Diseases, 11(3), 107. https://doi.org/10.3390/diseases11030107'}, {'pmid': '24112371', 'type': 'BACKGROUND', 'citation': "Enders LR, Hur P, Johnson MJ, Seo NJ. Remote vibrotactile noise improves light touch sensation in stroke survivors' fingertips via stochastic resonance. J Neuroeng Rehabil. 2013 Oct 11;10:105. doi: 10.1186/1743-0003-10-105."}, {'pmid': '22507444', 'type': 'BACKGROUND', 'citation': 'Caliandro P, Celletti C, Padua L, Minciotti I, Russo G, Granata G, La Torre G, Granieri E, Camerota F. Focal muscle vibration in the treatment of upper limb spasticity: a pilot randomized controlled trial in patients with chronic stroke. Arch Phys Med Rehabil. 2012 Sep;93(9):1656-61. doi: 10.1016/j.apmr.2012.04.002. Epub 2012 Apr 13.'}, {'pmid': '25486644', 'type': 'BACKGROUND', 'citation': 'Bark K, Hyman E, Tan F, Cha E, Jax SA, Buxbaum LJ, Kuchenbecker KJ. Effects of vibrotactile feedback on human learning of arm motions. IEEE Trans Neural Syst Rehabil Eng. 2015 Jan;23(1):51-63. doi: 10.1109/TNSRE.2014.2327229. Epub 2014 Jun 2.'}, {'type': 'BACKGROUND', 'citation': 'Alashram, A. and Annino, G. (2022). Focal muscle vibration reduces spasticity and improves functional level in incomplete spinal cord injury: a case report. Physikalische Medizin Rehabilitationsmedizin Kurortmedizin, 33(03), 162-165. https://doi.org/10.1055/a-1819-6874'}, {'type': 'BACKGROUND', 'citation': 'Afzal, M., Pyo, S., Oh, M., Park, S., & Yoon, J. (2018). Evaluating the effects of delivering integrated kinesthetic and tactile cues to individuals with unilateral hemiparetic stroke during overground walking. Journal of Neuroengineering and Rehabilitation, 15(1). https://doi.org/10.1186/s12984-018-0372-0'}, {'type': 'BACKGROUND', 'citation': 'Afzal, M., Lee, H., Eizad, A., Lee, C., Oh, M., & Yoon, J. (2019). Effects of vibrotactile biofeedback coding schemes on gait symmetry training of individuals with stroke. Ieee Transactions on Neural Systems and Rehabilitation Engineering, 27(8), 1617-1625. https://doi.org/10.1109/tnsre.2019.2924682'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to find out if Vibrotactile Stimulation (VTS) can help improve mobility and reduce spasticity (muscle stiffness) in people with lower limb spasticity. The study will also look at how VTS affects walking speed. The main questions it aims to answer are:\n\n* Which areas of the body are the best for applying VTS?\n* Does VTS help improve walking speed in people with lower limb spasticity?\n\nParticipants will:\n\n* Receive 15 minutes of VTS treatment on different parts of the body\n* Use the VTS device for 60 minutes during supervised lab sessions and at home (at rest and while walking)\n* Complete a daily log of how much time the device was used for and note any issues or difficulties the participant experience\n* Complete assessments after the treatment to measure change in mobility\n* Complete surveys about how comfortable the device is to use', 'detailedDescription': 'This study will investigate both the neurophysiological mechanisms and clinical effects of VTS in individuals with poststroke lower limb spasticity.\n\nAim 1 will assess how different anatomical placements of VTS impact neuromuscular activity and spasticity.\n\nAim 2 will test the feasibility and efficacy of VTS during both static and dynamic gait contexts using a randomized crossover design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥6 months following neurologic diagnosis leading to spasticity\n* Modified Ashworth Scale (MAS) score of 3 or lower on ankle plantar flexor.\n* Ability to stand (with or without assistance) and lie supine.\n* Able to understand and comply with study procedures.\n\nExclusion Criteria:\n\n* Uncontrolled systemic illness or serious medical conditions that could interfere with study procedures.\n* Previous surgery to treat spasticity in the affected lower limb.\n* Prior Botulinum Toxin (BoNT) therapy in the target limb within 4 months.\n* Unstable medication regimens for spasmolysis or muscle relaxation.\n* Participation in tone-related treatments (e.g., physiotherapy, TENS, acupuncture) within 4 weeks prior to baseline. If ongoing treatment started more than 4 weeks before baseline, it should remain consistent throughout the study'}, 'identificationModule': {'nctId': 'NCT07447934', 'briefTitle': 'Trial to Test the Effectiveness of Vibrotactile Stimulation for Lower Limb Spasticity', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Vibrotactile Stimulation for Lower Limb Spasticity', 'orgStudyIdInfo': {'id': '25-07029051'}, 'secondaryIdInfos': [{'id': 'UL1TR002384', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR002384', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VTS Static Use, then Dynamic Use (Aim 2)', 'description': 'The participant will first use the VTS device for 60 minutes daily for three consecutive days while in a static position. After a washout period of 1 week, the participant will use the VTS device for 60 minutes daily for three consecutive days during active gait training.', 'interventionNames': ['Device: Vibrotactile Stimulation (Static Use)']}, {'type': 'EXPERIMENTAL', 'label': 'VTS Dynamic Use, then Static Use (Aim 2)', 'description': 'The participant will first use the VTS device for 60 minutes daily for three consecutive days during active gait training. After a washout period of 1 week, the participant will use the VTS device for 60 minutes daily for three consecutive days while in a static position.', 'interventionNames': ['Device: Vibrotactile Stimulation (Dynamic Use)']}, {'type': 'OTHER', 'label': 'VTS Neurophysiological Mechanism (Aim 1)', 'description': 'The participant will use the VTS device for three 15-minutes sessions, once for each anatomical locations (i.e. muscle belly, origin, and insertion) around the leg and ankle.', 'interventionNames': ['Device: Vibrotactile Stimulation (Neurophysiological Mechanism)']}], 'interventions': [{'name': 'Vibrotactile Stimulation (Static Use)', 'type': 'DEVICE', 'description': 'The Vibrotactile Stimulation (VTS) device is a wearable, non-invasive therapeutic system designed to reduce spasticity and improve motor function in individuals with neurological impairments leading to lower limb spasticity. The device consists of a compact vibratory motor housed in a soft, adjustable strap that can be worn over targeted muscle groups (e.g., gastrocnemius/soleus complex).\n\nThe stimulation is delivered at a predefined frequency and amplitude, optimized based on prior research to modulate spinal reflex pathways and reduce motoneuron hyperexcitability.\n\nThe device will be worn during static conditions (e.g., standing or seated) and is intended for daily use at home or in-clinic.', 'armGroupLabels': ['VTS Static Use, then Dynamic Use (Aim 2)']}, {'name': 'Vibrotactile Stimulation (Dynamic Use)', 'type': 'DEVICE', 'description': 'The Vibrotactile Stimulation (VTS) device is a wearable, non-invasive therapeutic system designed to reduce spasticity and improve motor function in individuals with neurological impairments leading to lower limb spasticity. The device consists of a compact vibratory motor housed in a soft, adjustable strap that can be worn over targeted muscle groups (e.g., gastrocnemius/soleus complex).\n\nThe stimulation is delivered at a predefined frequency and amplitude, optimized based on prior research to modulate spinal reflex pathways and reduce motoneuron hyperexcitability.\n\nThe device will be used in dynamic conditions (e.g., walking) and is intended for daily use at home or in-clinic.', 'armGroupLabels': ['VTS Dynamic Use, then Static Use (Aim 2)']}, {'name': 'Vibrotactile Stimulation (Neurophysiological Mechanism)', 'type': 'DEVICE', 'description': 'The Vibrotactile Stimulation (VTS) device is a wearable, non-invasive therapeutic system designed to reduce spasticity and improve motor function in individuals with neurological impairments leading to lower limb spasticity. The device consists of a compact vibratory motor housed in a soft, adjustable strap that can be worn over targeted muscle groups (e.g., gastrocnemius/soleus complex). The stimulation is delivered at a predefined frequency and amplitude, optimized based on prior research to modulate spinal reflex pathways and reduce motoneuron hyperexcitability. The device will be used to investigate the neurophysiological mechanisms through which VTS modulates spasticity at different anatomical sites and its effectiveness on improving mobility. investigate the underlying neurophysiological mechanisms through which VTS modulates spasticity and muscle tone at different anatomical locations (i.e. muscle belly, origin, and insertion) around the leg and ankle.', 'armGroupLabels': ['VTS Neurophysiological Mechanism (Aim 1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Joan Stilling, MD., MS.', 'role': 'CONTACT', 'email': 'qsi9001@med.cornell.edu', 'phone': '212-746-1500'}], 'facility': 'Department of Rehabilitation Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Joan Stilling, M.D., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Following publication of the primary outcomes manuscript and completion of all planned analyses. Data will be available for up to 6 years after study completion.', 'ipdSharing': 'YES', 'description': 'De-identified participant-level data including demographic information, baseline and post-intervention assessments of spasticity, EMG/H-reflex measures, and functional outcomes (e.g., 10-Meter Walk Test, Modified Ashworth Scale). No direct identifiers or protected health information will be included.', 'accessCriteria': 'Qualified investigators affiliated with academic, clinical, or non-profit research institutions who submit a scientifically sound proposal consistent with the aims of the original study. Data will be made available through a controlled access process. Interested researchers should contact the Principal Investigator via institutional email. Approved applicants must sign a Data Use Agreement outlining terms of use, data protection requirements, and agreement to destroy data after the completion of approved analyses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}