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IRCT20220715055472N1 IRCT 2022-07-18 Tehran University of Medical Sciences To compare the effects of exergame and exercises with exercises only on functional activities in newly fitted patients with unilateral trans tibial amputation To compare the effects of exergame and exercises with exercises only on functional activities in newly fitted patients with unilateral trans tibial amputation 2021-10-01 anticipated 22 Complete https://irct.ir/trial/64769 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization in which 22 cards collected inside a plastic container. card with number one represent experimental group and card number two represent control group, Blinding description: The assessor was blinded to the type of group. N/A Exergame and exercises for patients with trans tibial amputation. Intervention 1: Experimental group: The patients did home strengthening exercise and gait training exercises to improve their strength, balance, gait pattern, and coordination under the supervision of the first author. After that, the patients played the six games using XBOX Kinect, 3 times per week for 4 weeks. Intervention 2: Control group: The patients in the control group received home strengthening exercise for the global muscles (quadriceps, hamstring, hip and core muscles) and gait training exercises only under the supervision of the first author. The protocol was 3 sessions per week for four weeks in total. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD, IPD collected for the primary outcome measure only When: starting 6 months after publication To whom: For academic and clinician physiotherapist and those who are working in the field of rehabilitation. Conditions: no specific criteria Where to obtain: first author and the journal How to obtain: email the author, or the journal Comments: no comments
public Mohammed Abdul Hussein Jabbar Al Sawaedi
NO.77 south west of new Baghdad
Baghdad Iraq 100001 +964 771 109 0342 mohamedphysiotherapy@yahoo.com Tehran University of Medical Sciences scientific Mohammed Abdul Hussein Jabbar Al Sawaedi
NO.77 south west of New Baghdad
Baghdad Iraq 100001 +964 771 109 0342 mohamedphysiotherapy@yahoo.com Tehran University of Medical Sciences Iraq Newly fitted patients with unilateral Trans-tibial amputation Age ranged from 30 to 65 years Be cognitively able to engage in the program (receive a score on the Arabic version of the Modified Mini-Mental Status Exam score of >23) Participants should not have any medical conditions (e.g., Congestive heart failure, Neurological disorder) that limit exercise participation. 30 years 65 years Male Unable to give informed consent Previous experience of using the XBOX Kinect™ Major cardiopulmonary problems. Rehabilitation Rehabilitation Experimental group: The patients did home strengthening exercise and gait training exercises to improve their strength, balance, gait pattern, and coordination under the supervision of the first author. After that, the patients played the six games using XBOX Kinect, 3 times per week for 4 weeks. Control group: The patients in the control group received home strengthening exercise for the global muscles (quadriceps, hamstring, hip and core muscles) and gait training exercises only under the supervision of the first author. The protocol was 3 sessions per week for four weeks in total. Distance of walking: 2MWT was administered to check the distance of walking in the meter before and after the intervention. The test was implemented on a walking path that is free from obstacles (including other people) and 50 feet in length as available. The measuring wheel was used to measure the exact distance be covered by the patient during the test. The physiotherapist holds the walking wheel and walk behind the patient to calculate the distance. The patient walked for 2 minutes and the distance was calculated automatically by measuring the wheel. The assistive device could be used and was documented from test to test. The time starts upon “Go” and stop timing at 2 minutes. The patient will be instructed as follows “Cover as much ground as possible over 2 minutes. Walk continuously if possible, but do not be concerned if you need to slow down or stop to rest. The goal is to feel at the end of the test that more ground could not have been covered in the 2 minutes.” There are different pathways that can be used in the 2MWT. in this study, “Out and Back” pathway was chosen. Timepoint: At baseline, after two weeks and after four weeks of the intervention. Method of measurement: 2 Minutes Walking test (2MWT). The speed of walking: The TUG test was used to assess the speed of walking before and after the intervention. Measuring tape, chair with armrest, tape to mark the ground, and stopwatch was used in this test. A 3-meter (or 9 ft, 10 in) walkway was measured by the measuring tape. On one end, a chair was placed facing down the walkway with the front legs as the start point of the 3-meter distance. On the other end, a piece of tape (or cone) was placed to serve as a marker. The patient sat on a chair with their back against the back rest preparing for the test. The patient was instructed as following; “When I say ‘go’, stand up and walk to the marker in front of you. Turn around once you get to the marker and return to your chair and sit. Make sure that you walk quickly, but safely.” the time that was required by the patient to complete the test, was measured. The stopwatch starts by saying, “Go” and stopped once the patient’s bottom contacts the chair. Usage of an assistive device was allowed and was documented consistently at each additional assessment. The patient was allowed one practice trial prior to the timed performance. The Clinical Metrics and Instructions Sheet includes updated tables with values for tested populations was printed and laminated and was used as a reference during the test. Timepoint: At baseline, after two weeks and after four weeks of the intervention. Method of measurement: Time up and Go test (TUG). Functional activities: The functional activities of the patient were measured using the Amputee Mobility Predictor with Prosthesis Test (AMPPRO) as described by Gailey . The test consists of 42 scores. The test was designed to assess the functional ambulation in patients with lower limb amputation. The AMP can be administered with a prosthesis (AMPPRO) or without a prosthesis (AMPPRE). In this study, the participants used their prosthesis for the test. The AMPPRO takes approximately 15 minutes to apply. AMP Scores have been correlated with the functional Medicare classification system of 0 - 4 . Mean AMP scores for each K level are: K1 0-1 (25), K2 2 (34.6), K3 3 (40.5), K4 4 (44.7). The AMPPRO is reliable and valid for patients with transtibial amputations with excellent interrater and interrater reliability and with intraclass coefficient (ICC) scores ranging from 0.96 to 0.99. Timepoint: At baseline, after two weeks and after four weeks of the intervention. Method of measurement: Amputee Mobility Predictor with Prosthesis test (AMPPro). Energy expenditure: The physiological Cost Index (PCI) was used to measure the energy expenditure. PCI is a reliable test to track the changes of metabolic energy expenditure. The test was administered during the 2MWT as follows: 1.The patient sits quietly for 2 minutes until the heart rate reaches a steady state.2. The walking speed was measured in meters per minute. The participants walked on a level surface at their preferred pace. 3.The working heart rate was measured using Polar H7 for measuring heart rate. 4.After finishing the 2MWT, the heart rate was subtracted and divided by walking speed to obtain the PCI in beat/meter (see the equation below). 5.The participants was instructed to avoid taking any tobacco, coffee/tea or a big meal at least 2 h before the PCI-test. Timepoint: At baseline, after two weeks and after four weeks of the intervention. Method of measurement: Physiological Cost Index test (PCI). Tehran University of Medical Sciences Approved 2021-09-26 Ethical Committee of Tehran University of Medical Sciences Central building, Ghods street, Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)