脳卒中患者におけるtDCSと痙縮
脳卒中患者の痙縮に対する経頭蓋直流刺激の効果
Multiple research has worked on tDCS and its impact on stroke. But none have studied the effects of tDCS on stroke in relation to the different stages of stroke like mild, moderate, moderate to severe and severe stroke as per national institute of health (NIH) scale.
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.
調査の概要
詳細な説明
Multiple noninvasive brain stimulation is also introduced over the few years regarding their impact on spasticity, tDCS being the most common due to its effects on spasticity. There are multiple structural and functional changes in motor cortex post stroke, tDCS causes improvement in motor control by reorganizing the motor cortex. Anodal and cathodal tDCS are based on the current direction with cathodal decreasing excitability of the cortex area and anodal increasing it. Anodal tDCS is more effective in reducing spasticity as compared to cathodal. The change in cortical excitation alters the reflex arc i.e. altering the neurons and reducing their excitability which causes a decrease in tone and facilitates neuroplasticity.
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
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Punjab Province
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Rawalpindi、Punjab Province、パキスタン
- Pakistan Railway Hospital
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Rawalpindi、Punjab Province、パキスタン、466000
- Pakistan Railway General Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Stroke for more than 6 months.
- 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:
- Have any metallic implant including intracranial electrode, pacemaker, surgical clip.
- Any symptoms effecting understanding of instructions.
- Any neurological disorder
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：従来型
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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 |
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実験的：tDCS
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Stimulation in each session will be applied for 20 min by two 5 × 7 cm (35 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 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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Modified Ashworth Scale
時間枠：8 week
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MAS is a tool to measure hypertonia. It scores the resistance on a 5 point ordinal scale with an increase value indicating hypertonia. Intrarater reliability of MAS was found to be good to excellent for upper (k= 0.71-0.94) and lower extremities(k= 0.55-0.97) while interrater reliability was poor to moderate for upper (k= 0.25-0.66)and lower extremities (k= 0.41-0.54) |
8 week
|
|
Fugl Meyr Assessment
時間枠：8 week
|
FMA is used for the assessment of physical performance and sensorimotor function of neurological patients. It uses a 3-point ordinal scale to score individuals' ability to perform a certain task. Total score is 226. It has excellent inter and intrarater reliability. (ICC 0.95) |
8 week
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
SS-QoL
時間枠：8 week
|
It is used for estimating the quality of life of stroke patients. It contains 49 questions related to different personal and social aspects. Scoring is done on a ordinal scale of 1-5 with an increase score indicating independence. It is a valid and reliable tool to use in stroke population (Cronbach's alpha 0.903) |
8 week
|
協力者と研究者
捜査官
- 主任研究者：Mirza Obaid Baig, MSPT、Riphah International University
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- REC02039 Aqsa Liaqat
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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