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IRCT20180109038285N2 IRCT 2022-05-01 National Institute for Medical Research Development The comparative effects of comprehensive protocol and routine physical therapy on pain, balance, disability and quality of life in patient with ankle sprain The comparative effects of comprehensive protocol and routine physical therapy on pain, balance, disability and quality of life in patient with chronic ankle instability 2018-07-01 anticipated 50 Complete https://irct.ir/trial/60382 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: in order to have equal number of participants, the random allocation of participants into two groups utilized the balanced block randomization method. In the present study, block randomization was run within blocks of four, there are six possible ways to equally assign participants to a block (A: intervention group; B: control group). All possible modes of the four blocks were written and numbered as follows: 1. AABB; 2. ABAB; 3. BBAA; 4. BABA; 5. ABBA; 6. BAAB. Consequently, in each block, two participants were assigned to the intervention group and two were assigned to the comparison group. The allocation sequence was prepared using the randomizer.org website before starting the study, with letter A for the intervention group and the letter B for the control group. The allocation sequence was prepared using the randomizer.org website before starting the study, with letter A for the intervention group and the letter B for the control group. In order to conceal the allocation sequence, 60 opaque envelopes were prepared, Blinding description: This study was performed in a double-blind manner so that the physiotherapist who performed the pre- and post-test was not involved in the treatment process, and in addition the person who analyzed the data was blind from the grouping allocation. 3 Chronic ankle instability. Intervention 1: Intervention group: It involved up to twelve face-to-face sessions over four weeks and each session last for approximately 45 minutes. Patients in the comprehensive group, during the four-week program, received a combination of specific exercises modified from updated evidence-based randomized controlled trials and conventional physiotherapy protocol. Intervention 2: Intervention group: It involved up to twelve face-to-face sessions over four weeks and each session last for approximately 45 minutes. Patients in the conventional group received exercises from standard physiotherapy which has been done in most randomized controlled trials elaborated in recent systematic reviews. Ankle strengthening (isometric, concentric, eccentric, weight bearing, and non-weight bearing), stretching, and retraining exercise and talocrural and subtalar mobilization were done each session. Yes - There is a plan to make this available What will be shared: Information on the assessed outcome after publishing the article, is available When: Start of access period 6 months after printing To whom: Researchers working in academic and scientific institutions Conditions: In order to find a better way to treat ankle sprains, the data will be used after the article is published. Where to obtain: Dr. Hossein Neghaban honegahban@yahoo.com How to obtain: If the applicant needs the data, he / she will receive the data after giving an electronic message to Dr. Hossein Neghaban, and at his / her discretion. Comments:
public Hossein Negahban
Khorasan Razavi, Mashhad, Azadi Square, east door of the university campus
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 honegahban@yahoo.com Mashhad University of Medical Sciences scientific Hossein Negahban
Khorasan Razavi, Mashhad, Azadi Square, east door of the university campus
ئشسااشی Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 honegahban@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) History of unilateral chronic ankle instability Answer “yes” to at least five Yes/No questions of 9 questions of Persian-version of ankle instability instrument Age between 18-68 year 18 years 68 years Both severe or constant pain and swelling radicular pain from the lumbar or buttock region history of lower extremity surgery lower extremity fracture ankle fracture or surgery Rehabilitation Rehabilitation Intervention group: It involved up to twelve face-to-face sessions over four weeks and each session last for approximately 45 minutes. Patients in the comprehensive group, during the four-week program, received a combination of specific exercises modified from updated evidence-based randomized controlled trials and conventional physiotherapy protocol Intervention group: It involved up to twelve face-to-face sessions over four weeks and each session last for approximately 45 minutes. Patients in the conventional group received exercises from standard physiotherapy which has been done in most randomized controlled trials elaborated in recent systematic reviews. Ankle strengthening (isometric, concentric, eccentric, weight bearing, and non-weight bearing), stretching, and retraining exercise and talocrural and subtalar mobilization were done each session. Disability. Timepoint: Before starting physiotherapy and after completing physiotherapy sessions. Method of measurement: FAAM and FAOS questionnaires. Pain. Timepoint: Pre-intervention and immediately after finishing the physiotherapy sessions. Method of measurement: Visual Analog Scale. Range of motion. Timepoint: Pre-intervention and immediately after physiotherapy sessions. Method of measurement: Calibrated goniometer. Balance. Timepoint: Pre-intervention and immediately after physiotherapy sessions. Method of measurement: Star excursion balance test. Treatment effectiveness. Timepoint: Immediately after the physiotherapy sessions. Method of measurement: Global rating of change. IR.NIMAD.REC.1397.008 National Institute for medical research Development (NIMAD) National Institute for Medical Research Development Approved 2018-07-01 Ethics committee of National Institute for Medical Research Development West Fatemi Street Tehran Tehran Iran (Islamic Republic of)