search
Back to results

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

Primary Purpose

Stroke, Spasticity, Muscle

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Shock wave therapy with multiphasic neuroplasticity based training protocol
Conventional physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Neuroplasticity,, Exercise, Stroke, post stroke spasticity, Electromyography, Ultrasonography

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
    • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Riphah international universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shock wave therapy with multiphasic neuroplasticity based training protocol

Conventional physical therapy

Arm Description

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

Stretching and strengthing and motor sensory motor training of effected side

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Resting joint angle
Resting joint angle will showa the spasticity, the most the angle is narrow the more the mucle is spastic
EMG study
Fwave , H reflexElectrophysiological assessment, such as measurement of the reflex activities Spastic muscle: Ankle planter flexor, Knee flexor
Ultrasonography
to examine disruptions in the normative architecture of spastic muscles. Muscle length (MFL),Muscle thickness (MT) Muscle pennation angle
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.
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.
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)
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.
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.

Full Information

First Posted
May 31, 2022
Last Updated
August 4, 2022
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05405140
Brief Title
Multiphasic Neuroplasticity Based Training Protocol With Shock Wave Therapy For Post Stroke Spasticity
Official Title
Multiphasic Neuroplasticity Based Training Protocol With Shock Wave Therapy For Post Stroke Spasticity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spasticity, Muscle
Keywords
Neuroplasticity,, Exercise, Stroke, post stroke spasticity, Electromyography, Ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shock wave therapy with multiphasic neuroplasticity based training protocol
Arm Type
Experimental
Arm Description
Shock wave therapy with multiphasic neuroplasticity based training protocol based on motor relearning program and task oriented approach
Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
Stretching and strengthing and motor sensory motor training of effected side
Intervention Type
Other
Intervention Name(s)
Shock wave therapy with multiphasic neuroplasticity based training protocol
Intervention Description
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 .
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified ashworh scale
Description
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.
Time Frame
6th weeks
Secondary Outcome Measure Information:
Title
Resting joint angle
Description
Resting joint angle will showa the spasticity, the most the angle is narrow the more the mucle is spastic
Time Frame
6th weeks
Title
EMG study
Description
Fwave , H reflexElectrophysiological assessment, such as measurement of the reflex activities Spastic muscle: Ankle planter flexor, Knee flexor
Time Frame
6th weeks
Title
Ultrasonography
Description
to examine disruptions in the normative architecture of spastic muscles. Muscle length (MFL),Muscle thickness (MT) Muscle pennation angle
Time Frame
6th weeks
Title
Time up and Go
Description
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.
Time Frame
6th weeks
Title
Burg Balance scale
Description
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.
Time Frame
6th weeks
Title
Functional independence measure
Description
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)
Time Frame
6th weeks
Title
Barthal index
Description
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.
Time Frame
6th weeks
Title
Rivermead Mobility Index
Description
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.
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, phD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabiya Noor, PHD
Organizational Affiliation
Riphah international university lahore campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah international university
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabiya Noor, phD
Phone
03344355660
Email
rabiya.noor@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Binash Afzal, phD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33551718
Citation
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.
Results Reference
background
PubMed Identifier
31191637
Citation
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.
Results Reference
background
PubMed Identifier
22668675
Citation
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.
Results Reference
background
PubMed Identifier
34927035
Citation
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.
Results Reference
background
PubMed Identifier
33383655
Citation
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.
Results Reference
background
PubMed Identifier
31710277
Citation
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.
Results Reference
background
PubMed Identifier
32691303
Citation
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.
Results Reference
background
PubMed Identifier
34669820
Citation
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.
Results Reference
background
PubMed Identifier
15083447
Citation
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.
Results Reference
background
PubMed Identifier
29403314
Citation
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.
Results Reference
background
PubMed Identifier
20878038
Citation
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.
Results Reference
background
PubMed Identifier
33164953
Citation
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.
Results Reference
background
PubMed Identifier
34544853
Citation
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.
Results Reference
background
PubMed Identifier
31313626
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs