Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
56 participants
INTERVENTIONAL
2024-10-01
2025-07-31
Brief Summary
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Additionally, this study will be conducted to address the few drawbacks in previous studies such as short follow up period by employing evidence based standardized protocols. It can potentially instigate the efficacy of tDCS on spasticity, motor recovery and Quality of life in relation to the different severity levels of stroke.
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Detailed Description
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Spasticity is often found along with weakness in stroke and is one of the reasons for impaired motor function, increased resistance to stretch and is due to increased excitability and abnormal regulation of spindle and reflex arc. With chronicity and reduced motor control spasticity also increases by 97 %. Spasticity and paresis lead to impaired motor control. Spasticity will not change recovery in function in early stages but is going to affect motor recovery in all stages. Spasticity disrupts motor function and the daily tasks which creates different levels of dependence in the patients hence effecting the QOL. Spasticity is found in almost 40% of individuals suffering from stroke. It affects joints and extremities in a way that impedes function and ADLs. Painful, restricted joints resulting from prolonged spasticity badly impacts the QOL leading to high burden on caregivers
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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tDCS
tDCS
Stimulation in each session will be applied for 20 min by two 5 × 4 cm (20 cm2) saline-soaked sponge electrodes at an intensity of 1.5 mA (0.075 mA/cm2). A gradual ramp up and down of stimulation for 10 s at the beginning and the end of stimulation
Conventional
ROM exercises for upper and lower extremities, Stretching of agonists, Strengthening of antagonists, Core stability exercises, Static and dynamic balance activities, Gait training, Functional training
Conventional
Conventional
ROM exercises for upper and lower extremities, Stretching of agonists, Strengthening of antagonists, Core stability exercises, Static and dynamic balance activities, Gait training, Functional training
Interventions
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tDCS
Stimulation in each session will be applied for 20 min by two 5 × 4 cm (20 cm2) saline-soaked sponge electrodes at an intensity of 1.5 mA (0.075 mA/cm2). A gradual ramp up and down of stimulation for 10 s at the beginning and the end of stimulation
Conventional
ROM exercises for upper and lower extremities, Stretching of agonists, Strengthening of antagonists, Core stability exercises, Static and dynamic balance activities, Gait training, Functional training
Eligibility Criteria
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Inclusion Criteria
* Both genders.
* Spasticity score ≥1 at modified ashworth scale.
* National Institutes of Health Stroke Scale (NIHSS) for severity level; Mild (1-4), Moderate (5-15), Moderate to Severe (16-20), Severe (21-42)
Exclusion Criteria
* Any symptoms effecting understanding of instructions.
* Any neurological disorder
30 Years
70 Years
ALL
No
Sponsors
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Riphah International University
OTHER
Responsible Party
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Principal Investigators
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Mirza Obaid Baig, MSPT
Role: PRINCIPAL_INVESTIGATOR
Riphah International University
Locations
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Pakistan Railway General Hospital
Rawalpindi, Punjab Province, Pakistan
Pakistan Railway Hospital
Rawalpindi, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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Zeng H, Chen J, Guo Y, Tan S. Prevalence and Risk Factors for Spasticity After Stroke: A Systematic Review and Meta-Analysis. Front Neurol. 2021 Jan 20;11:616097. doi: 10.3389/fneur.2020.616097. eCollection 2020.
Cheng H, Fang X, Liao L, Tao Y, Gao C. Prevalence and factors influencing the occurrence of spasticity in stroke patients: a retrospective study. Neurol Res. 2023 Feb;45(2):166-172. doi: 10.1080/01616412.2022.2127249. Epub 2022 Sep 25.
Lackritz H, Parmet Y, Frenkel-Toledo S, Banina MC, Soroker N, Solomon JM, Liebermann DG, Levin MF, Berman S. Effect of post-stroke spasticity on voluntary movement of the upper limb. J Neuroeng Rehabil. 2021 May 13;18(1):81. doi: 10.1186/s12984-021-00876-6.
Li S, Francisco GE, Rymer WZ. A New Definition of Poststroke Spasticity and the Interference of Spasticity With Motor Recovery From Acute to Chronic Stages. Neurorehabil Neural Repair. 2021 Jul;35(7):601-610. doi: 10.1177/15459683211011214. Epub 2021 May 12.
Wang X, Ge L, Hu H, Yan L, Li L. Effects of Non-Invasive Brain Stimulation on Post-Stroke Spasticity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Brain Sci. 2022 Jun 27;12(7):836. doi: 10.3390/brainsci12070836.
Other Identifiers
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REC02039 Aqsa Liaqat
Identifier Type: -
Identifier Source: org_study_id
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