Effects of Kinesio Taping in Subacute Stroke Patients

Официальное название

Effects of Kinesio Taping on Gait Ability, Balance, and Neuromuscular Functions in Subacute Stroke Patients With Foot Drop

Обзор

A study was designed to investigate the effects of KT on gait ability, balance, and neuromuscular functions in subacute stroke patients with foot drop. The study aims to evaluate the immediate and short-term effects of KT on gait ability, balance, and neuromuscular function in subacute stroke patients with foot drop. A total of 60 participants will be recruited and randomly assigned to either a control group (conventional physical therapy) or an experimental group (receiving additional KT). Both groups will receive 30 minutes of daily physical therapy. The experimental group will undergo an initial assessment before KT application, which includes (1) activation of the dorsiflexor muscles, (2) reduction of plantar flexor spasticity, and (3) stabilization of the ankle in an everted position. After taping, a second assessment will be conducted immediately, and the tape will stay applied to patient's limb for two days, followed by a third assessment. The control group will be assessed only before the intervention and after two days. Primary outcome measures include gait ability (10-meter walk test, laboratory gait parameters, and joint angles and electromyographic activity during walking). Secondary outcomes include balance (Functional reach test, Timed Up and Go test, and Activities-specific Balance Confidence Scale) and neuromuscular function assessments (muscle strength, joint range of motion, spasticity, and proprioception). This project aims to establish and validate a clinically applicable and effective KT protocol as an adjunctive gait training method for subacute stroke patients with foot drop. By enhancing independent and safe walking, this intervention may facilitate the early return to normal daily activities for stroke survivors.

Вмешательства

• Поведенческое KT group
  Receiving additional KT
• Поведенческое Conventional group
  Conventional physical therapy

Первичные конечные точки

• Gait ability - 10 meter walk test [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Gait ability - Speed (m/s) [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Gait ability - Cadence (steps/minute) [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Gait ability - Stride length (m) [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Gait ability - Step length (m) [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Gait ability - Percentages of stance phase (%) [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Gait ability - Percentages of swing phase (%) [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Gait ability - Gait symmetry (%) [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Gait ability - first maximum toe clearance (cm) [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Gait ability - second maximum toe clearance (cm) [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]

Вторичные конечные точки (7)

• Functional reach test [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Timed Up and Go test [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Activities-specific Balance Confidence Scale [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Muscle strength [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Joint range of motion [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Spasticity [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]
• Proprioception [Срок оценки: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)]

Критерии участия

Критерии включения

• Age between 20 and 80 years;
• First unilateral stroke;
• Stroke onset between at least 1 week and 1 year;
• Ability to continuously walk 10 meters with or without assistive devices;
• Presence of foot drop on the affected side during the swing phase due to insufficient ankle dorsiflexion;
• Brunnstrom stage of the affected lower limb ≥ 3;
• Presence of mild spasticity in the affected ankle plantar flexors, with a Modified Ashworth Scale score ≤ 2;
• Ability to follow simple commands

Критерии исключения

• Other neurological disorders or unstable medical conditions;
• Skin allergies that interfere with the use of tape;
• Visual field defects;
• Cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score < 24;
• Pusher syndrome;
• Ankle contracture;
• Hemispatial neglect;
• Poorly controlled hypertension or cardiovascular disease;
• Any other disease, apart from stroke, that may affect balance or gait.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07192484 · KSVGH25-CT6-22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗