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临床试验/NCT07192484
NCT07192484尚未招募不适用

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

Fooyin University0 个研究点目标入组 60 人开始时间: 2025年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Gait ability - 10 meter walk test

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

KT group

Experimental

Receiving additional Kinesio taping

干预措施: KT group (Behavioral)

Control group

Other

Conventional physical therapy

干预措施: Conventional group (Behavioral)

结局指标

主要结局

Gait ability - 10 meter walk test

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. The examiner uses a stopwatch to record the time taken to walk the middle 10 meters, and then divides the distance (10 meters) by the time to calculate the walking speed.

EMG activity (µV) of tibialis anterior during walking

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. EMG activity (µV) of tibialis anterior during walking will be recorded using the commercially wireless system (Delsys Inc., United States).

Gait ability - Gait symmetry (%)

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

Gait symmetry (%) will be recorded using the commercially available portable gait analysis system (Gait Up).

Gait ability - first maximum toe clearance (cm)

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. The first maximum toe clearance (cm) will be recorded using the commercially available portable gait analysis system (Gait Up).

Gait ability - second maximum toe clearance (cm)

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. The second maximum toe clearance (cm) will be recorded using the commercially available portable gait analysis system (Gait Up).

Gait ability - minimum toe clearance (cm)

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. The minimum toe clearance (cm) will be recorded using the commercially available portable gait analysis system (Gait Up).

Ankle joint range (degrees) during walking

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. Ankle joint range (degrees) during walking will be recorded using the commercially wireless system (Delsys Inc., United States).

EMG activity (µV) of gastrocnemius during walking

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. EMG activity (µV) of gastrocnemius during walking will be recorded using the commercially wireless system (Delsys Inc., United States).

Gait ability - Speed (m/s)

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. Speed (m/s) will be recorded using the commercially available portable gait analysis system (Gait Up).

Gait ability - Cadence (steps/minute)

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. Cadence (steps/minute) will be recorded using the commercially available portable gait analysis system (Gait Up).

Gait ability - Stride length (m)

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. Stride length (m) will be recorded using the commercially available portable gait analysis system (Gait Up).

Gait ability - Step length (m)

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. Step length (m) will be recorded using the commercially available portable gait analysis system (Gait Up).

Gait ability - Percentages of stance phase (%)

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. Percentages of stance phase (%) will be recorded using the commercially available portable gait analysis system (Gait Up)

Gait ability - Percentages of swing phase (%)

时间窗: 1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3)

The participant will be asked to walk at a comfortable speed along a 14-meter walkway. Percentages of swing phase (%) will be recorded using the commercially available portable gait analysis system (Gait Up).

次要结局

  • Functional reach test(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(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(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(1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3))
  • Spasticity(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(1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3))
  • Proprioception(1. Baseline (prior to KT application, Day 1) 2. Immediately after KT application (Day 1) 3. 48 hours after KT application (Day 3))

研究者

申办方类型
Other
责任方
Sponsor

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