Evaluation of Lower Extremity Interventions in Individuals With Chronic Stroke

NCT07258342 | Active Not Recruiting

• 1 other identifier: MU-SBF-FTR-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of closed kinetic chain (CKC) exercises and kinesio taping on knee joint proprioception, balance, functional performance, and quality of life in individuals with chronic stroke. Stroke often results in proprioceptive deficits and postural control impairments, which negatively impact rehabilitation outcomes. While CKC exercises are believed to enhance proprioceptive input through joint compression and sensory feedback, kinesio taping is used as a complementary intervention to support motor control and stability. The study will compare the effects of these two interventions to determine their potential roles in improving sensorimotor function and promoting functional independence in stroke rehabilitation. A total of 30 participants were enrolled in this study. Inclusion Criteria:

• Patients who had a stroke more than 6 months ago,
• Having a stable medical condition,
• Ability to understand simple instructions,
• Individuals with spasticity between grades 0-2 according to the Modified Ashworth Scale,
• Individuals who can walk independently or with assistive devices,
• Those who agree to participate and comply with the study procedures. Exclusion Criteria:
• Severe cognitive impairment (MMSE score \< 24),
• Orthopedic conditions that may cause knee pain during exercise,
• Other neurological conditions that may affect proprioception,
• Severe joint contracture,
• Refusal or unwillingness to participate in the study.

Conditions

Chronic Stroke Patients; Lower Extremity; Knee Proprioception; Closed Kinetic Chain Exercises; Kinesiotape; Physiomaster

Outcome Measures

Primary Outcomes (1)

• Measurement of knee joint position sense

  Knee joint position sense will be evaluated using active and passive joint position sense tests. Prior to testing, the limb will be passively moved 10 times to prepare for the movement. The Physiomaster mobile application will be used to measure the angular difference between the affected and unaffected knees at the end of the movement. Active joint position sense will be measured by asking participants to replicate a 45° knee flexion angle with their eyes closed. The angular error will be calculated. Passive joint position sense will be assessed by passively positioning the knee, then asking participants to estimate the angle after returning to the starting position. Repetitive flexion and extension movements will be performed, and error detection will be recorded. Placebo movements will be included in the evaluation.

  2 months

Secondary Outcomes (4)

• Berg Balance Scale (BBS)

  2 months

• Timed Up and Go Test (TUG)

  2 months

• 10-Meter Walk Test (10MWT)

  2 months

• Stroke-Specific Quality of Life Scale (SS-QOL)

  2 months

Study Arms (2)

the group engaged in closed kinetic chain exercises

EXPERIMENTAL

Closed kinetic chain exercises of the lower extremity are typically performed with the feet secured to a stable object that generates compressive forces at the hip, knee, and ankle joints. Participants will perform closed kinetic chain exercises in 40-minute sessions, twice a week for 8 weeks. Each exercise will be repeated 3 to 5 times, depending on the individual's strength .Exercises include: wall squats, forward and upward step-ups, side and upward step-ups, double-leg squats, bridges, and quadriceps isometric strengthening exercises.

Other: Measurement of Knee Joint Position Sense; Other: Berg Balance Scale (BDS); Other: Timed Up and Go Test (TUG); Other: 10-Meter Walking Test; Other: Stroke-Specific Quality of Life Scale

Kinesiotaping Group (KB)

EXPERIMENTAL

Kinesiotaping will be applied to increase proprioceptive awareness of the knee joint. Taping will be applied using the \*"Y" technique and \*"I" technique, focusing on medial and lateral support. The kinesio tape will remain in place for 3 days, followed by a 1-day break, and then reapplied. Tape changes will be performed by a physical therapist for a total of 8 weeks.

Other: Measurement of Knee Joint Position Sense; Other: Berg Balance Scale (BDS); Other: Timed Up and Go Test (TUG); Other: 10-Meter Walking Test; Other: Stroke-Specific Quality of Life Scale

Interventions

Measurement of Knee Joint Position Sense OTHER

Joint position sense will be assessed using active and passive joint position sense tests. Before starting the movement, the extremity will be moved ten times to prepare for movement. The "Physio Master" phone application will be used to measure the angle difference between the affected and unaffected knees at the end point of the movement. With the individual sitting upright with their back straight, knees flexed at 90 degrees, the participant's knee will be flexed to 45 degrees and the participant will be asked to repeat the same angle with their eyes closed. The error in angles (°) will be calculated. Passive position sense will be measured and recorded by passively moving the participant to the determined angle (15-30-45-60) and then asking them to estimate the angle upon returning to the starting position. Repeated flexion and extension will be performed to assess any errors in the movement. Placebo exercises will also be administered during the assessment. The test was repeated t

Kinesiotaping Group (KB); the group engaged in closed kinetic chain exercises

Berg Balance Scale (BDS) OTHER

The Berg Balance Scale was developed primarily to assess postural control and is widely used in many rehabilitation settings. The 14 items in the scale assess expected balance during common activities of daily living, including standing and static sitting balance, as well as turning, picking up objects from the floor, and transfers. Scoring is typically done on a 5-point scale that assesses whether the patient can perform the task safely and independently for a specific time period. A score of 0 is given when the patient cannot perform the movement at all, and a score of 4 is given when the patient completes the movement independently. The maximum score is 56, with a score of 0-20 indicating impaired balance, 21-40 indicating acceptable balance, and 41-56 indicating good balance. The completion of the scale takes approximately 10 to 20 minutes. The Turkish validity and reliability study of the scale was conducted by Şahin et al. in 2008 on stroke patients.

Kinesiotaping Group (KB); the group engaged in closed kinetic chain exercises

Timed Up and Go Test (TUG) OTHER

It measures the time it takes for a patient to stand up from a chair, walk 3 meters, turn, and sit back down. The test time was recorded in seconds. The test was repeated three times, and the average time was recorded as a score. If necessary, the patient was allowed to perform the test using a walking aid. It is an objective clinical measurement used to assess functional mobility, dynamic balance, and fall risk in older individuals. It has also been shown to be a valid and reliable test in stroke patients.

Kinesiotaping Group (KB); the group engaged in closed kinetic chain exercises

10-Meter Walking Test OTHER

This test is used to determine walking speed. Two to three trials will be conducted at both comfortable and maximum speeds of their choosing. Participants will be instructed to walk at a "normal comfortable speed" or "as fast as safely possible." No practice trials will be conducted, and participants will rest for at least 30 seconds between trials. Typical shoes, standard orthotics, and any necessary assistive devices will be worn. Participants will walk approximately 14 meters, including a 2-meter acceleration and deceleration zone. The time participants spend walking the middle 6 meters of this walkway will be measured with a stopwatch, from the moment their toes first pass the starting cone to the moment they first pass the finishing cone. Walking speed will be calculated for each trial.

Kinesiotaping Group (KB); the group engaged in closed kinetic chain exercises

Stroke-Specific Quality of Life Scale OTHER

Quality of life is also an important prognostic indicator for stroke and provides a broader definition of the disease. This scale consists of 49 items in 12 domains: mobility, energy, upper extremity functionality, work/productivity, mood, self-care, social roles, family roles, vision, language, thinking, and personality. SS-QOL items are assessed on a five-point Likert-type scale. Responses range from 1 (Strongly disagree) to 5 (Strongly agree). High scores on the scale indicate high quality of life, while low scores indicate low quality of life.

Kinesiotaping Group (KB); the group engaged in closed kinetic chain exercises

Eligibility Criteria

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

You may qualify if:

• Patients who had a stroke more than 6 months ago,
• Individuals with a medically stable condition,
• Ability to understand simple instructions,
• Individuals with spasticity graded between 0 and 2 according to the Modified Ashworth Scale,
• Individuals who can walk independently or with assistive devices,
• Individuals who agree to participate in the study and are able to comply with the study procedures.

You may not qualify if:

• Severe cognitive impairment (Mini-Mental Test score \< 24),
• Orthopedic conditions that may cause knee pain during exercise,
• Other neurological conditions that may affect proprioception,
• Severe joint contracture,
• Individuals who do not wish to voluntarily participate in the study.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Özel İncirli Akademi Özel eğitim ve rehabilitasyon merkezi

Istanbul, Bakırköy, 34147, Turkey (Türkiye)

Location

Study Officials

• Dilanur Ö Özkaraoğlu, Doctor Physiotherapist

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 2, 2025
• Study Start: May 30, 2025
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)