Comparison of Virtual Reality and Motor Imagery Applications in Patients With Ankle Instability

Ankle Sprains Clinical Trial

Official title:

Comparison of Virtual Reality and Motor Imagery Applications in Patients With Ankle Instability

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06356818
• Other study ID #: E-74555795-050.04-941155
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Doaa HAKAM, PT
• Phone: +905345456224
• Email: d.hakam[@]ogr.iuc.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the effects of different treatment methods for ankle instability patients are being compared aiming to find the optimal treatment. Via comparing virtual reality, motor imagery, and classic rehabilitation programs to clarify their effects on ankle static and dynamic balance, proprioception, range of motion, muscle strength, pain, function and patient satisfaction.

Description:

This study will be carried out at Istanbul University-Cerrahpaşa Department of Physiotherapy and Rehabilitation with 30 participants. Subjects who meet the inclusion criteria and who voluntarily agree to participate in this study will be randomly divided into 3 study groups as conventional physiotherapy rehabilitation treatment program, Conventional + virtual reality (VR) group and Conventional + VR+ motor imagery (MI) group. Group 1 (Conventional physiotherapy program): Physiotherapy and rehabilitation treatment program will be applied to the patients. In this program, a 30-40-minute exercise protocol covering proprioceptive, balance and strengthening exercises will be implemented. Group 2; VR group: in addition to the conventional physiotherapy program virtual reality (VR) program will be applied to this group using balance and strengthening games by Nintendo Wii Fit Plus; warm-up exercise (5 minutes), workout (20 minutes) and cool-down exercise (5 minutes) for a total of 30 minutes. Group 3; Motor imagery (MI): this group will be introduced to explicit Motor imagery program adding to Conventional physiotherapy and VR programs. The content of the imagery program will last 20 minutes in total, with 5 minutes of relaxation and 15 minutes of imagery training.

All patients in the groups will be treated for a total of 12 sessions, 3 days a week, over a 4-week period. Session duration will vary according to the groups. Interventions will last approximately 40-80 minutes.

Ankle mobility and instability will be assessed through different tests. Balance parameters will be measured with the Star Balance Test for dynamic balance and the Single Leg Stance Test for static balance. The pain intensity will be measured with the Pressure Pain Threshold device also with Visual Analog Scale. Muscle strength will be assessed with a manual muscle test. Ankle range of motion and joint position feeling will be measured with a mobile application such as an inclinometer. Finally, 2 questionnaires will be used to assess functional ability and patient satisfaction. These are; Cumberland ankle instability tool and Global Assessment Scale questionnaire respectively. All of the assessment parameters (outcomes measurement) will be evaluated twice, pre-treatment and post-treatment (after 4 weeks).Which approximately will take from 30 to 45 minutes.

G*Power analysis program was used to calculate the sample size of the study. While the Cumberland ankle instability tool (CAIT) change results were taken as reference, the effect size was calculated as 1.35, and the number of subjects to be included in the study was reported as a total of 15 patients (Group 1: 5/Group 2: 5/Group 3: 5) in order to be determined as significant with 95% power and type 1 error=0.05,however, the exclusion rate was added as 25% and it has been decided to include a total of 30 patients (Group 1: 10/Group 2: 10/Group 3: 10) (1). SPSS (Statistical Package for Social Sciences) (SPSS 20.0) statistical program will be used for statistical analysis of the data obtained. In all analyzes, p<0.05 will be considered statistically significant. Before the final analysis, the data will be screened to test the normality assumption using the Shapiro-Wilk test, which reflects normal distribution (p > 0.05). Furthermore, Levene's test was used to test homogeneity of variance and no significant difference was found (p > 0.05). If the data are normally distributed, parametric analysis (e.g. t-Test, ANOVA, Paired t-Test and Linear Regression) will be used, otherwise non-parametric analysis (e.g. Mann-Whitney U Test, Wilcoxon Signed-Rank Test, Kruskal-Wallis Test and Spearman's Rank Correlation) will be used.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Subjects with =27 points according to the Cumberland ankle parameter (=27 points represent unstable ankles) (12).

• Patients with both mechanical and functional instability

• Patients with instability after ankle sprain

• Patients with sub-acute (10 days after injury) and chronic ankle instability

• Diseases/patients without surgical indication

• Cases between the ages of 18-39

• Gender (Male-Female)

Exclusion Criteria:

• Patients with acute ankle instability

• Athletes with ankle instability

• Previous history of lower extremity surgery

• Those with a Cumberland Ankle Instability Instrument (CAIT) score of less than 24.

• Cannot walk without a supportive walking aid.

• Participants in another exercise program that may affect their feet.

• Subjects who have been involved in different treatments for instability in the last 3 months

• Patients with neurologic, rheumatologic or vestibular problems will be excluded (14).

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains

Intervention

Other:
• Conventional physiotherapy program
Physiotherapy and rehabilitation treatment program will be applied to the patients. In this program, a 30-40-minute exercise protocol covering proprioceptive, balance and strengthening exercises will be implemented. For a total of 12 sessions, 3 days a week, over a 4-week period
• Virtual reality (VR)
virtual reality (VR) program will be applied using balance and strengthening games by Nintendo Wii Fit Plus; warm-up exercise (5 minutes), workout (20 minutes) and cool-down exercise (5 minutes) for a total of 30 minutes. For a total of 12 sessions, 3 days a week, over a 4-week period
• Motor imagery (MI)
Patients will be introduced to explicit Motor imagery program which the content of the imagery program will last 20 minutes in total, with 5 minutes of relaxation and 15 minutes of imagery training. For a total of 12 sessions, 3 days a week, over a 4-week period.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa (IUC)	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	Visual Analog Scale (VAS) will be used for pain assessment. This test is a subjective, valid, and reliable test also it is time-saving and easy to apply and understand by the patient as the patient will be asked to scale their pain from 0 to 10 as 0 referring to: no pain and 10 referring to : maximum severe pain.	two weeks
Primary	Pressure Pain Threshold (PPT)	The Pressure Pain Threshold (PPT) is used to measure pain. This test is an objective valid, and reliable test which will provide us with more accurate results according to the sensation of pain. It is also time-saving and easy to apply. The PPT test will be applied to the most painful area on the ankle joint and the result will be compared with the other extremity, as well as with a healthy area close to an area such as the tibialis anterior. The calculation will be done with kilograms.	two weeks
Primary	Star Excursion Balance Test (SEBT)	Dynamic balance and instability will be evaluated using the Star Excursion Balance Test (SEBT) for dynamic balance assessment. This test is time-efficient and does not require the use of special equipment. It could be proceeded easily with a simple setup four strips of tape will need to be cut to a length of 183 to 244 cm each. Two pieces will be used to form a '+', with the other two being placed over top to form an 'x' so that a star shape is formed. It is important that all lines are separated from each other by a 45° angle. The goal of the SEBT is to maintain a single leg stance on one leg while reaching as far as possible with the contralateral leg. The results will be obtained in centimeters.	two weeks
Primary	Single Leg Balance Test (SLBT)	The Single Leg Balance Test (SLBT) will be used to assist static balance. This test is applicable easy test without any need for special devices or setup. Simply we will ask the participant to stand on one leg and we will calculate the average of three trials in each limb, the patient will be administered for 3 minutes with eyes open and another 3 minutes with eyes closed with a maximum time of one minute for each trial. The duration starts when the patient lifts his foot off the ground and ends when his foot touches the ground. The test ends when the foot moves, or the time reaches the maximum (60 seconds).	two weeks
Primary	Joint position sense (JPS)	Proprioception, Joint position sense (JPS) will be measured using mobile applications such as Tiltmeter for iPhone and Handy Level (inclinometer) for Android (8). Nowadays using mobile applications for assessment is becoming a widely accepted, valid and reliable method which is affordable and applicable. In order to accurately calculate JPS the active ankle repositioning technique will be used. Individuals will be asked to relocate their feet in dorsiflexion and plantarflexion directions to two targets (10° and 15°). During the JPS measurements, all patients will be blindfolded to eliminate the contribution of vision.	two weeks
Primary	Range of Motion (ROM)	Range of Motion (ROM), will be calculated with inclinometer mobile application. Using mobile application will make it easier to obtain ankle ROM (dorsiflexion, planterflexion, inversion and eversion). In this test ROM will be calculated to clarify the baseline (normal range of motion) of the ankle and find out the changes before and after the intervention. Also to perform the proprioception test from the correct starting position.	two weeks
Primary	Muscle strength	Lower extremity muscle strength will be assessed using manual muscle testing (MMT). MMT is a fundamental method which is not requiring any devices or setup. We will use the available literature as a reference to apply MMT in the most reliable and valid way. According to the evaluation method (0 - No contraction, 1 - Vibration or feeling of contraction, 2 - Active movement with removal of gravity, 3 - Active movement against gravity, 4 - Active movement against gravity and resistance, 5 - Normal strength) (10). Plantarflexors, dorsiflexors muscle groups, tibialis anterior muscle and hip abductor muscle group will be evaluated.	two weeks
Secondary	Cumberland ankle instability questionnaire (CAIT)	Functional ability will be assessed with the Cumberland ankle instability questionnaire (CAIT). Which is a valid, reliable, time-saving and easily understood tool. The CAIT is a 9-item 30-point scale using a numeric value that measures the severity of ankle instability. The participant will be asked to answer these questions for both ankles.	two weeks
Secondary	Patient satisfaction	By using the Global Rating Scale patient satisfaction will be measured by asking the patient directly how satisfied they are with the treatment provided. This tool is an easy direct one ,which is a 5-point Likert scale. Patient Satisfaction (after treatment) is scored as: much worse, worse, same, better and much better.	two weeks