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IRCT20230205057336N1 IRCT 2023-03-16 Shiraz University of Medical Sciences Assessment of lumbopelvic manipulation on balance in chronic ankle instability patients Comparing the effect of ankle and lumbopelvic manipulation with ankle manipulation alone on static and dynamic balance in people with chronic ankle instability 2023-04-15 anticipated 52 Complete https://irct.ir/trial/68427 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done based on the Randomizer software. For input information in this software, the following must be entered: Number of groups: 2 Number of people in each group: 26 The total number of people studied: 52 After entering this information in the software, the software presents 26 numbers with a random order between 1 and 52 for the first group and 26 numbers with a random order between 1 and 52 for the second group. These numbers will be placed in each group. How to hide: based on the size of the research sample, a number of non-transparent envelopes are prepared (in order to make the content of the envelopes unclear) and each of the random sequences is recorded on a card and the cards are placed inside the envelope in order In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the envelope is glued and placed inside a box in order. Qualified to study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed, Blinding description: In this study, the person who performs the evaluation is different from the person who performs the treatments. Also, data analysis is done by another person who is unaware of the evaluation and treatment. N/A Chronic ankle instability. Intervention 1: Intervention group: receive lumbopelvic manipulation and ankle manipulation along with exercise. In lumbopelvic manipulation, the patient lies supine on the bed. The therapist stands on the opposite side of the injured ankle. After locking the fingers behind the head by the patient, the therapist bends the patient's trunk towards the injured ankle and rotates it in the opposite direction. Then, a thrust with low intensity and high speed is applied to the anterior superior cruciate spine in the posterior and downward direction.Manipulation of the ankle is done while the person is lying in the arched position. The therapist's hands are wrapped proximal to the leg and fingers at the level of the neck of the talus. The therapist then applies a high-speed, low-intensity thrust in the downward direction. The exercise protocol includes mobilization exercises for the foot and ankle, mild strengthening exercises, strengthening exercises for the muscles around the ankle using theraband, strengthening exercises using body weight, standing on one leg, balance exercises on the balance board. Interventions will be conducted twice a week for 4 weeks. Intervention 2: Control group: they receive ankle manipulation along with exercise. The therapist's hands are wrapped proximal to the leg and fingers at the level of the neck of the talus. Then the therapist inserts a thrust with high speed and low intensity in the downward direction. The exercise protocol includes mobilization exercises for the foot and ankle, mild strengthening exercises, strengthening exercises for the muscles around the ankle using theraband, strengthening exercises using body weight, standing on one leg, balance exercises on the balance board. Interventions will be conducted twice a week for 4 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After preparing and completing the data file, it will be available to readers or other scientific people if needed.
public Narges Meftahi
Abiverdi St 1, Chamran Blvd
Shiraz Iran (Islamic Republic of) 71947-33669 +98 71 3627 1551 meftahin@sums.ac.ir Shiraz University of Medical Sciences scientific Narges Meftahi
Abiverdi St 1, Chamran Blvd
Shiraz Iran (Islamic Republic of) 71947-33669 +98 71 3627 1551 meftahin@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Having a report of chronic ankle instability according to the form announced by the International Ankle Association, in such a way that the person declares that they have a condition in which they feel the ankle is unstable during daily activities and sports activities, and usually with the fear of developing an acute sprain People who have a history of at least one ankle sprain in the last 12 months, which was accompanied by symptoms of inflammation and prevented them from doing their daily activities for at least one day At least 3 months have passed since the last injury People who have a feeling of instability or recurrent ankle sprains (2 or more cases in one ankle) or ankle sprains (at least two cases in the 6 months before the study) People who score less than 24 from the Cumberland ankle instability tools (CAIT) questionnaire. To investigate chronic ankle instability and the presence of instability, the Persian version of the CAIT questionnaire is used. This questionnaire consists of 9 questions, after completing it, a score between 0 and 30 is obtained. A score equal to and above 24 indicates stability, and a score below 24 indicates chronic instability. This questionnaire has been translated into Farsi, which has good validity and reliability People who score less than 90% for daily activities from the questionnaire (FAAM) foot and ankle ability measures. This questionnaire includes 21 items related to daily activities and 8 items related to sports. Each item is scored from zero to four, where zero means no ability to do it and 4 means no difficulty in doing it. ADL total score is from 0 to 84 and exercise score is from 0 to 32. Then these scores are calculated as a percentage. For instability, the ADL score should be less than 90% and the exercise score should be less than 80%. This questionnaire has been translated into Farsi and is a valid and reliable tool in determining the physical performance of people who have foot and ankle disorders People aged 18-45 18 years 45 years Both Athletes (those who have special and regular sports training at least three times a week) Rheumatic diseases History of surgery or fracture on vertebrae and lower limb History of abdominal surgery Myelopathy, radiculopathy or nerve compression Taking similar treatments for ankle in the last 3 months Any neurological disease such as diabetic neuropathy or multiple sclerosis Chronic non-specific back pain Vestibular or balance disorders diagnosed by a physician History of damage to the central nervous system Taking sleeping pills 12 hours before balance tests Uncorrected visual impairment Any contraindication to manipulation such as spine and ankle hypermobility History of taking corticosteroid drugs Osteopenia and osteoporosis following metabolic diseases Sacroiliac problems Measurements should not be taken during the monthly cycle M25.373 Other instability, unspecified ankle Treatment - Other Treatment - Other Intervention group: receive lumbopelvic manipulation and ankle manipulation along with exercise. In lumbopelvic manipulation, the patient lies supine on the bed. The therapist stands on the opposite side of the injured ankle. After locking the fingers behind the head by the patient, the therapist bends the patient's trunk towards the injured ankle and rotates it in the opposite direction. Then, a thrust with low intensity and high speed is applied to the anterior superior cruciate spine in the posterior and downward direction.Manipulation of the ankle is done while the person is lying in the arched position. The therapist's hands are wrapped proximal to the leg and fingers at the level of the neck of the talus. The therapist then applies a high-speed, low-intensity thrust in the downward direction. The exercise protocol includes mobilization exercises for the foot and ankle, mild strengthening exercises, strengthening exercises for the muscles around the ankle using theraband, strengthening exercises using body weight, standing on one leg, balance exercises on the balance board. Interventions will be conducted twice a week for 4 weeks. Control group: they receive ankle manipulation along with exercise. The therapist's hands are wrapped proximal to the leg and fingers at the level of the neck of the talus. Then the therapist inserts a thrust with high speed and low intensity in the downward direction. The exercise protocol includes mobilization exercises for the foot and ankle, mild strengthening exercises, strengthening exercises for the muscles around the ankle using theraband, strengthening exercises using body weight, standing on one leg, balance exercises on the balance board. Interventions will be conducted twice a week for 4 weeks. Static balance. Timepoint: Before the start of the intervention, immediately after the end of intervention, two weeks and one month after the end of intervention. Method of measurement: balance score static scale test, Biodex Balance machine. Dynamic balance. Timepoint: Before the intervention, immediately after the end of the intervention, two weeks and one month after the intervention. Method of measurement: Y balance test, biodex balance machine. Pain. Timepoint: before the start of the intervention, immediately after the end of the intervention, two weeks and one month after the intervention. Method of measurement: Visual analogue scale. Ankle dorsiflexion rang of motion. Timepoint: BeforeBefore the intervention, immediately after the end of the intervention, two weeks and one month after the intervention. Method of measurement: Goniometer. Shiraz University of Medical Sciences Approved 2022-12-20 Ethics Committee in Shiraz Faculty of Rehabilitation Sciences Research Abiverdi St 1, Chamran Blvd Shiraz Fars Iran (Islamic Republic of)