Multiphasic Neuroplasticity Based Training Protocol With Shock Wave Therapy For Post Stroke Spasticity

NCT05405140 | Completed

• 1 other identifier: REC/RCR&AHS/22/1102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

this study will be conducted to f find the effects of multiphasic neuroplasticity based training protocol with Shock Wave Therapy on Neurophysiological, Morphological and Functional Parameters of Post Stroke Spasticity.

Conditions

Stroke; Spasticity, Muscle

Keywords

Neuroplasticity,; Exercise; Stroke; post stroke spasticity; Electromyography; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Modified ashworh scale

  Modified Ashworth Scale (MAS) is used to assess spasticity. Scoring is between 0 to 4 where 0 means no increase in muscle tone and 4 means limb is rigid in flexion or extension.

  6th weeks

Secondary Outcomes (8)

• Resting joint angle

  6th weeks

• EMG study

  6th weeks

• Ultrasonography

  6th weeks

• Time up and Go

  6th weeks

• Burg Balance scale

  6th weeks

Study Arms (2)

Shock wave therapy with multiphasic neuroplasticity based training protocol

EXPERIMENTAL

Shock wave therapy with multiphasic neuroplasticity based training protocol based on motor relearning program and task oriented approach

Other: Shock wave therapy with multiphasic neuroplasticity based training protocol

Conventional physical therapy

ACTIVE COMPARATOR

Stretching and strengthing and motor sensory motor training of effected side

Other: Conventional physical therapy

Interventions

Shock wave therapy with multiphasic neuroplasticity based training protocol OTHER

Interventions program will be based on Activity dependent neuroplasticity targeting relevant impairments included: task specific practice, motor learning, strengthening, postural awareness, Balance training, aerobic and conditioning exercises, range of movement with Shock wave therapy for most of time of the day .

Shock wave therapy with multiphasic neuroplasticity based training protocol

Conventional physical therapy OTHER

The CP program focused on the facilitation of movements on the paretic side, range of motion, stretching exercises, upper and lower limb strengthening exercises, and improving balance, standing, sitting, transferring, patients received a program for at least 30 sessions, 5 times per week for 6 or more weeks.

Conventional physical therapy

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years.
• Those had a stroke more than 3 months ago
• Unilateral stroke
• Able to participate in therapy regime or Participate in an ambulatory rehabilitation program.
• They having problematic spasticity either focal or generalized.
• Upper or lower limb spasticity (MAS ≥ 2) interfering with function or causing a clinical problem, and no contraindications to shock wave therapy.
• if the improvement in spasticity is realistically expected
• they will be considered suitable for to shock wave therapy
• Minimental scale examination (MMSE).
• Comprehensive Severity Index (CSI) for severity assessment.

You may not qualify if:

• If they had had received treatment with BoNT-A within six months
• Will receiving intrathecal baclofen or other anti-spasticity medications
• If patients will be on to anticoagulants.
• had undergone neurolysis or surgery to the affected limb;
• had concomitant neurological conditions

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah international university

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (15)

• Leng Y, Lo WLA, Hu C, Bian R, Xu Z, Shan X, Huang D, Li L. The Effects of Extracorporeal Shock Wave Therapy on Spastic Muscle of the Wrist Joint in Stroke Survivors: Evidence From Neuromechanical Analysis. Front Neurosci. 2021 Jan 21;14:580762. doi: 10.3389/fnins.2020.580762. eCollection 2020.

  PMID: 33551718 BACKGROUND

• Carey L, Walsh A, Adikari A, Goodin P, Alahakoon D, De Silva D, Ong KL, Nilsson M, Boyd L. Finding the Intersection of Neuroplasticity, Stroke Recovery, and Learning: Scope and Contributions to Stroke Rehabilitation. Neural Plast. 2019 May 2;2019:5232374. doi: 10.1155/2019/5232374. eCollection 2019.

  PMID: 31191637 BACKGROUND

• Arya KN, Verma R, Garg RK, Sharma VP, Agarwal M, Aggarwal GG. Meaningful task-specific training (MTST) for stroke rehabilitation: a randomized controlled trial. Top Stroke Rehabil. 2012 May-Jun;19(3):193-211. doi: 10.1310/tsr1903-193.

  PMID: 22668675 BACKGROUND

• Hsu PC, Chang KV, Chiu YH, Wu WT, Ozcakar L. Comparative Effectiveness of Botulinum Toxin Injections and Extracorporeal Shockwave Therapy for Post-Stroke Spasticity: A Systematic Review and Network Meta-Analysis. EClinicalMedicine. 2021 Dec 4;43:101222. doi: 10.1016/j.eclinm.2021.101222. eCollection 2022 Jan.

  PMID: 34927035 BACKGROUND

• Mihai EE, Dumitru L, Mihai IV, Berteanu M. Long-Term Efficacy of Extracorporeal Shock Wave Therapy on Lower Limb Post-Stroke Spasticity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2020 Dec 29;10(1):86. doi: 10.3390/jcm10010086.

  PMID: 33383655 BACKGROUND

• Cabanas-Valdes R, Calvo-Sanz J, Urrutia G, Serra-Llobet P, Perez-Bellmunt A, German-Romero A. The effectiveness of extracorporeal shock wave therapy to reduce lower limb spasticity in stroke patients: a systematic review and meta-analysis. Top Stroke Rehabil. 2020 Mar;27(2):137-157. doi: 10.1080/10749357.2019.1654242. Epub 2019 Nov 11.

  PMID: 31710277 BACKGROUND

• Xing Y, Bai Y. A Review of Exercise-Induced Neuroplasticity in Ischemic Stroke: Pathology and Mechanisms. Mol Neurobiol. 2020 Oct;57(10):4218-4231. doi: 10.1007/s12035-020-02021-1. Epub 2020 Jul 20.

  PMID: 32691303 BACKGROUND

• Penna LG, Pinheiro JP, Ramalho SHR, Ribeiro CF. Effects of aerobic physical exercise on neuroplasticity after stroke: systematic review. Arq Neuropsiquiatr. 2021 Sep;79(9):832-843. doi: 10.1590/0004-282X-ANP-2020-0551.

  PMID: 34669820 BACKGROUND

• Dejong G, Horn SD, Gassaway JA, Slavin MD, Dijkers MP. Toward a taxonomy of rehabilitation interventions: Using an inductive approach to examine the "black box" of rehabilitation. Arch Phys Med Rehabil. 2004 Apr;85(4):678-86. doi: 10.1016/j.apmr.2003.06.033.

  PMID: 15083447 BACKGROUND

• Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018 Jan 18;10:153-157. doi: 10.2147/CLEP.S146397. eCollection 2018.

  PMID: 29403314 BACKGROUND

• Yelnik AP, Simon O, Parratte B, Gracies JM. How to clinically assess and treat muscle overactivity in spastic paresis. J Rehabil Med. 2010 Oct;42(9):801-7. doi: 10.2340/16501977-0613.

  PMID: 20878038 BACKGROUND

• Rahayu UB, Wibowo S, Setyopranoto I, Hibatullah Romli M. Effectiveness of physiotherapy interventions in brain plasticity, balance and functional ability in stroke survivors: A randomized controlled trial. NeuroRehabilitation. 2020;47(4):463-470. doi: 10.3233/NRE-203210.

  PMID: 33164953 BACKGROUND

• Dromerick AW, Geed S, Barth J, Brady K, Giannetti ML, Mitchell A, Edwardson MA, Tan MT, Zhou Y, Newport EL, Edwards DF. Critical Period After Stroke Study (CPASS): A phase II clinical trial testing an optimal time for motor recovery after stroke in humans. Proc Natl Acad Sci U S A. 2021 Sep 28;118(39):e2026676118. doi: 10.1073/pnas.2026676118.

  PMID: 34544853 BACKGROUND

• Linder SM, Rosenfeldt AB, Davidson S, Zimmerman N, Penko A, Lee J, Clark C, Alberts JL. Forced, Not Voluntary, Aerobic Exercise Enhances Motor Recovery in Persons With Chronic Stroke. Neurorehabil Neural Repair. 2019 Aug;33(8):681-690. doi: 10.1177/1545968319862557. Epub 2019 Jul 17.

  PMID: 31313626 BACKGROUND

• Afzal B, Noor R, Alghwiri AA, Umar A. Effects of Extracorporeal Shockwave Therapy Combined with Neuroplasticity-Based Training Protocol on Lower Limb Spasticity in Stroke Patients: A Randomized Controlled Trial with Ultrasonography Evaluation. NeuroRehabilitation. 2026 Jan 7:10538135251403026. doi: 10.1177/10538135251403026. Online ahead of print.

  PMID: 41499331 DERIVED

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Motor Activity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Rabiya Noor, PHD

  Riphah international university lahore campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 6, 2022
• Study Start: May 20, 2022
• Primary Completion: August 15, 2023
• Study Completion: October 15, 2023
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)