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StrokeNCT05405140

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

A study testing Shock wave therapy with multiphasic neuroplasticity based training protocol and Conventional physical therapy in people with Stroke and Spasticity, Muscle, run by Riphah International University at 1 site in Pakistan.

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

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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Stroke, Spasticity, Muscle
What is being tested?
Shock wave therapy with multiphasic neuroplasticity based training protocol and Conventional physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
20 May 2022to 15 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 40 - 70years.
  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah international university

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

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.

Read the detailed description

Spasticity is a common sensory-motor dysfunction observed following a stroke. Spasticity is a velocity-dependent increase in resistance during a passive stretch due to hyper excitability of stretch reflex. This results in many functional impairments and patients centered problems. Given the complexity of spasticity related issues, its rehabilitation must entail comprehensive approach which address and synchronize spasticity reduction with motor function restoration without compensation. Shock Wave Therapy (SWT) is a non-invasive low cost devise gaining its use for spasticity reduction. After damage brain undergoes some sort of rearrangement. Literature says that during this period if it will rehabilitated through new pattern functional recovery can be optimized. However there is paucity of evidence for effectiveness of multiphasic neuroplasticity based Training protocol (MNTP) with SWT regarding its intensity frequency and specificity for spasticity management.

It will be a mix method approach. The patients after full filling the inclusion criteria , age ranging between 45 to 65 years having a stroke more than 3 months ago and having problematic spasticity interfering with function or causing a clinical problem, and no contraindications to shock wave therapy Upper or lower limb spasticity MAS ≥ 1 will be randomly assigned into four groups A,B,C,D. All groups will receive conventional rehabilitation training for 30 min per day five times a week for 4 weeks .Moreover patients in group A,BC also receive added SWT, MNTP and a combination of MNTP and SWT respectively. Motor recovery and spasticity will be using clinical (modified Asworth scale, Tardieu scale), neurophysiological, morphological(muscle ultrasound) and functional parameter( Fugl -meyer, burg balance, time up and go, Barthal index, Rivermeads mobility index ) at 0 , 8 and 16 week of treatment. The methodological approach used in this, will encompasses quantitative methods to assess program effectiveness and mixed methods to evaluate rehabilitation program components and aspects of protocol implementation. Qualitative methodology is needed to capture the range of participant experiences in the real- life clinical setting.

Being tested
Shock wave therapy with multiphasic neuroplasticity based training protocol, Conventional physical therapy
Keywords
Neuroplasticity,, Exercise, Stroke, post stroke spasticity, Electromyography, Ultrasonography
Medical subject headings
Stroke, Muscle Spasticity, Motor Activity

What participants receive

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

  • Shock wave therapy with multiphasic neuroplasticity based training protocolOther

    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 .

  • Conventional physical therapyOther

    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.

Study groups in NCT05405140
Study groupRoleWhat they receive
Shock wave therapy with multiphasic neuroplasticity based training protocolExperimentalShock wave therapy with multiphasic neuroplasticity based training protocol based on motor relearning program and task oriented approach
Receives: Other: Shock wave therapy with multiphasic neuroplasticity based training protocol
Conventional physical therapyActive comparatorStretching and strengthing and motor sensory motor training of effected side
Receives: Other: Conventional physical therapy

What is being measured

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

  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.

    Measured: 6th weeks

Secondary outcomes (8)
  1. Resting joint angle

    Resting joint angle will showa the spasticity, the most the angle is narrow the more the mucle is spastic

    Measured: 6th weeks

  2. EMG study

    Fwave , H reflexElectrophysiological assessment, such as measurement of the reflex activities Spastic muscle: Ankle planter flexor, Knee flexor

    Measured: 6th weeks

  3. Ultrasonography

    to examine disruptions in the normative architecture of spastic muscles. Muscle length (MFL),Muscle thickness (MT) Muscle pennation angle

    Measured: 6th weeks

  4. Time up and Go

    To determine fall risk and measure the progress of balance, sit to stand and walking. ≤ 10 seconds = normal. ≤ 20 seconds = good mobility, can go out alone, mobile without gait aid. ≤ 30 seconds = problems, cannot go outside alone, requires gait aid. * A score of ≥ 14 seconds has been shown to indicate high risk of falls.

    Measured: 6th weeks

  5. Burg Balance scale

    It is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling.

    Measured: 6th weeks

  6. Functional independence measure

    The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability. The FIM's assessment of degree of disability depends on the patient's score in 18 categories, focusing on motor and cognitive function. Each category or item is rated on a 7-point scale (1 = <25% independence; total assistance required, 7 = 100% independence)

    Measured: 6th weeks

  7. Barthal index

    The Barthel Scale/Index is an ordinal scale used to measure performance in activities of daily living (ADL). It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. The amount of time and physical assistance required to perform each item are used in determining the assigned value of each item. External factors within the environment affect the score of each item. If adaptations outside the standard home environment are met during assessment, the participant's score will be lower if these conditions are not available.

    Measured: 6th weeks

  8. Rivermead Mobility Index

    The Rivermead Mobility Index assesses functional mobility in gait, balance and transfers after stroke. Items receive a score of 0 for a "No" response and 1 for a "Yes" response. Total scores are determined by summing the points for all items. A maximum of 15 points is possible; higher scores indicate better mobility performance. A score of "0" indicates an inability to perform any of the activities on the measure.

    Measured: 6 week

Timeline

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

  1. First posted6 Jun 2022
  2. Study start20 May 2022
  3. Primary completion15 Aug 2023
  4. Study completion15 Oct 2023

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05405140
Sponsor's protocol ID
REC/RCR&AHS/22/1102
Status last verified
Mar 2025
First submitted
31 May 2022
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33551718
  • 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.

    PubMed 31191637
  • 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.

    PubMed 22668675
  • 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.

    PubMed 34927035
  • 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.

    PubMed 33383655
  • 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.

    PubMed 31710277
  • 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.

    PubMed 32691303
  • 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.

    PubMed 34669820
  • 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.

    PubMed 15083447
  • 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.

    PubMed 29403314
  • 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.

    PubMed 20878038
  • 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.

    PubMed 33164953
  • 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.

    PubMed 34544853
  • 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.

    PubMed 31313626
  • 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 Feb;58(1):154-172. doi: 10.1177/10538135251403026. Epub 2026 Jan 7.

    PubMed 41499331

Questions about this trial

What is this clinical trial studying?

A study testing Shock wave therapy with multiphasic neuroplasticity based training protocol and Conventional physical therapy in people with Stroke and Spasticity, Muscle, run by Riphah International University at 1 site in Pakistan.

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 10 inclusion and 5 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 12 Mar 2025. 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 Pakistan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Modified ashworh scale (time frame: 6th weeks). 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 NCT05405140, which also lists 15 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 12 Mar 2025.

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