Comparative Effects of SBES Versus TOT on Lower Limb Motor Function in Post-Stroke Patients
Comparative Effects of Synergy-Based Electrical Stimulation Versus Task-Oriented Training on Lower Limb Motor Function in Post-Stroke Patients
Stroke-induced lower limb impairments severely inhibit functional independence and mobility in survivors. Inventive techniques like Synergy-Based Electrical Stimulation (SBES) and Task-Oriented Training (TOT) support favorable rehabilitation results based on Neuroplasticity. This study aims to compare the effectiveness of these in restoring purposeful movements and enhancing motor functions in post-stroke patients.This study aims to compare the efficacy of (SBES) and Task-Oriented Training (TOT) in improving lower limb motor control in sub-acute post-stroke patients.
This study will be a single-blinded randomized clinical trial design. Participants, aged 40-60 will be recruited in this study by Non-Probability convenience sampling from Rehabilitation centers and Neurology departments. Informed consent and consistent attendance throughout the intervention will be required. Through the computerized table generator method of randomization, participants will be evenly divided into two groups. Both groups will receive conventional therapy, like stretching, strengthening, and isometrics, with modalities. Group A will receive 30 Hz electrical stimulation on the affected lower limb muscles (hip flexors, knee flexors, and ankle dorsiflexors) in a synergic pattern, for 60 minutes, thrice weekly for 6 weeks. Group B will engage in functional tasks for 60 minutes, thrice weekly for 6 weeks, repeated 10 times per set with 2 sets of each activity, plus an additional self-practice session. Outcome measures will be assessed at baseline and post-intervention stages by the Fugl-Meyer Assessment for motor recovery, Time UP and Go Test (TUG) and 10 Meter Walk Test for functional mobility, gait, and balance. The paired sample t-test will be used for within-group analysis in the parametric data and the Wilcoxon test for non-parametric data, whereas, for between-group analysis independent t-test will be used for parametric data and Mann Whitney U test will be used for non-parametric data. Statistical analysis will be done by using SPSS version 26.
Keywords: Lower Limb, motor control, SBES, Strength, Stroke, TOT.
調査の概要
状態
詳細な説明
The synopsis will be presented to the Research Ethical Committee of Riphah International University, Lahore, for ethical approval to conduct this study.
RECRUITMENT:
Eligible participants will be recruited from Neurology departments and Rehabilitation centers.
RANDOMIZATION:
Patients will be recruited using a non-probability convenience sampling technique, and then they will be divided into two groups by simple random sampling through sealed, opaque envelopes.
BLINDNESS:
This study will be a single-blinded study in which the outcome assessor will be blind.
INTERVENTION:
Participants who will meet the inclusion criteria will be recruited, and written informed consent will be obtained before enrollment. The initial assessment will include the Fugl-Meyer Assessment to measure motor recovery and the 10-M Walk Test and TUG to evaluate functional mobility. Participants will be allocated to either the Synergy-Based Electrical Stimulation (SBES) group or the Task-Oriented Training group.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Punjab Province
-
Lahore、Punjab Province、パキスタン、54000
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age: 40 to 60 years
- Both Male and Female participants
- In the sub-acute phase of stroke (1-6 months post-stroke) with lower limb motor impairment but with the ability to initiate at least trace muscle contraction (Grade ≥ 1).
- Participants must have the ability to understand and follow simple verbal commands with the Mini-Mental State Examination (MMSE) ≥ 26.
- Participants must have a first-ever ischemic and hemorrhagic stroke in the sub-acute stage.
- Participants who are functionally ambulatory and able to walk a minimum of 10 feet, with or without the use of assistive devices with a Functional Ambulation Category (FAC) score ≥ 2.
Exclusion Criteria:
- Participants have severe cognitive impairment and an inability to understand or follow instructions, and severe sensory impairment with profound sensory loss in the lower limb affecting balance or feedback-based training.
- Participants having orthopedic limitations like recent fractures, joint deformities, or surgeries affecting the lower limbs.
- Participants having implanted electrical devices like pacemakers are contraindicated for electrical stimulation
- Participants having a history of more than one stroke episode and or multiple infarcts.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Therapy
Hot pack and isometric exercises
|
Synergy based visible but comfortable muscle contraction in semi-supine position, surface electrodes on hip and knee flexors and dorsiflexors.• Intensity adjusted based on tolerance • Monitor muscle response and patient comfort Tot Sit-to-stand, reaching, weight shifting, gait training, ball-kicking, tandem/side walking• Increase intensity by slightly reducing assistance • Add unstable surfaces for gait |
|
アクティブコンパレータ：Conventional Therapy
Hot pack and isometric exercises
|
Synergy based visible but comfortable muscle contraction in semi-supine position, surface electrodes on hip and knee flexors and dorsiflexors.• Intensity adjusted based on tolerance • Monitor muscle response and patient comfort Tot Sit-to-stand, reaching, weight shifting, gait training, ball-kicking, tandem/side walking• Increase intensity by slightly reducing assistance • Add unstable surfaces for gait |
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 |
|---|---|---|
|
Fugl-Meyer Assessment:
時間枠：Baseline to 4 weeks
|
The Fugl-Meyer Assessment for Lower Extremity (FMA-LE) is a reliable tool to evaluate motor recovery in post-stroke patients.
It consists of 17 items divided into five sections: reflex activity, volitional movement within synergy, mixing synergies, movement with little or no synergy, and coordination/speed.
Each item is scored from 0 to 2, giving a maximum score of 34.
Higher scores indicate better motor function.
Reflex activity includes 3 items (max 6 points), synergy movements have 6 items (12 points), mixed synergy includes 2 items (4 points), isolated movements have 3 items (6 points), and coordination/speed includes 3 items (6 points).
The heel-to-shin test is used for coordination.
Scoring interpretation is: 0-10 severe, 11-20 moderate, 21-29 mild, and 30-34 minimal impairment.
It takes 20-30 minutes and is administered by a trained professional.
|
Baseline to 4 weeks
|
|
The Timed Up and Go (TUG) Test
時間枠：Baseline to 4 weeks
|
This is a quick and reliable assessment used to evaluate mobility, balance, and fall risk in older adults and patients with neurological conditions like stroke.
It involves timing how long it takes for a person to stand from a chair, walk three meters, turn, return, and sit down.
Times under 10 seconds indicate normal mobility, while over 30 seconds suggest high fall risk.
The test is simple, requires minimal equipment, and is widely used in clinical and rehabilitation settings.
It helps monitor patient progress and guides treatment planning.
|
Baseline to 4 weeks
|
|
10-Meter Walk Test
時間枠：Baseline to 4 weeks
|
The 10MWT is a quick and reliable assessment of gait speed over a short distance, commonly used in stroke rehabilitation.
It involves timing a patient when they walk a 10-m path, typically within a 14-m walkaway to account for acceleration and deceleration.
The test can be performed at a comfortable or fast pace.
Gait speed is calculated in meters per second and is considered a strong predictor of functional mobility, fall risk, and community ambulation.
It is widely used to monitor progress in stroke patients.
|
Baseline to 4 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
その他の研究ID番号
- REC/RCR & AHS/25/0211
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。