Effects of Kinesio Taping in Subacute Stroke Patients

NCT07192484 | Not Yet Recruiting

• 1 other identifier: KSVGH25-CT6-22
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke Gait Rehabilitation

Outcome Measures

Primary Outcomes (14)

• Gait ability - 10 meter walk test

  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.

  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)

  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).

  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)

  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).

  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)

  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).

  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)

  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).

  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 (%)

  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)

  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 (%)

  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).

  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 (%)

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

  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)

  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).

  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)

  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).

  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 - minimum toe clearance (cm)

  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).

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

• Ankle joint range (degrees) during walking

  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).

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

• EMG activity (µV) of tibialis anterior during walking

  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).

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

• EMG activity (µV) of gastrocnemius during walking

  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).

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

Secondary Outcomes (7)

• 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)

• 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)

• 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)

Study Arms (2)

KT group

EXPERIMENTAL

Receiving additional Kinesio taping

Behavioral: KT group

Control group

OTHER

Conventional physical therapy

Behavioral: Conventional group

Interventions

KT group BEHAVIORAL

Receiving additional KT

KT group

Conventional group BEHAVIORAL

Conventional physical therapy

Control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fooyin University: lead

Central Study Contacts

I-Hsuan Chen

CONTACT

886-7-7811151 #7043; Y0894@fy.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 25, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share