]>
IRCT20240703062314N1 IRCT 2025-10-11 The University of Shahid Beheshti Comparison of two types of exercise on walking, balance, and quality of life in people with below-knee amputation Comparison of the Effect of Single-Task and Dual-Task Training on Gait and Quality of Life in People with Unilateral Transtibial Amputation: A Randomized Control Trial; RCT 2025-10-23 anticipated 45 Complete https://irct.ir/trial/78576 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization will be performed using SPSS software. The steps are planned as follows: 1- First, a random variable will be created using the Transform > Compute Variable tool. This variable will be defined with the formula TRUNC(RV.UNIFORM(0,1) * 3) + 1, which randomly assigns individuals to one of three groups (1, 2, or 3). 2- The data will be sorted based on this variable using the Data > Sort Cases tool. 3- Finally, participants will be randomly divided into three groups: the control group (number 1) and two experimental groups (numbers 2 and 3). This method represents a simple and transparent randomization process that will be applied in the future for the execution of the study. N/A Unilateral Transtibial Amputation. Intervention 1: Intervention Group 1: Single-task Exercises, Participants in the first intervention group followed a single-task exercise program. These exercises included balance movements, lower-limb resistance exercises (such as half squats, modified lunges, and leg raises), and stretching exercises, all performed without any accompanying cognitive task. The program was carried out over 8 weeks, three sessions per week, with each session lasting 60 minutes (10 minutes warm-up, 40 minutes main exercises, and 10 minutes cool-down). The exercises were conducted in the rehabilitation hall using simple equipment such as exercise mats, resistance bands, and chairs, under the supervision of the researcher. Intervention 2: Intervention Group 2: Dual-task Exercises, Participants in this group, in addition to performing the same motor exercises as Group 1 (balance, resistance, and stretching exercises), simultaneously carried out a simple cognitive task such as backward counting or reciting predetermined words. The aim was to examine the combined effect of physical and cognitive exercises on balance and gait. The program lasted 8 weeks, with three sessions per week, and each session was 60 minutes long (10 minutes warm-up, 40 minutes main exercises integrating motor and cognitive tasks, and 10 minutes cool-down). The exercises were performed in the rehabilitation hall using simple equipment such as exercise mats, resistance bands, and chairs, under the supervision of the researcher. Intervention 3: Control group: The control group did not receive any intervention (in this study, it means cognitive and motor exercises). 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 There is no further information
public Faezeh Saeidi Rashk Olia
Unit 1, No. 4, Nowruzi Alley, Salehi Alley, Bani Hashem Street, North Majidiyeh
Tehran Iran (Islamic Republic of) 1663745111 +98 21 2631 7602 faezehsaeedi.ro@gmail.com The University of Shahid Beheshti scientific Faezeh Saedi Rashk Olia
Unit 1, No. 4, Nowruzi Alley, Salehi Alley, Bani Hashem Street, North Majidiyeh
Tehran Iran (Islamic Republic of) 1663745111 +98 21 2631 7602 faezehsaeedi.ro@gmail.com The University of Shahid Beheshti Iran (Islamic Republic of) Unilateral transtibial amputation Age between 18 and 50 years Body mass index between 22 and 29 kilograms per square meter Continuous use of prosthesis for at least one year Ability to walk at least ten meters without assistance Montreal Cognitive Assessment score greater than twenty-one K-level 2 functional level 18 years 50 years Both Presence of any medical or orthopedic condition affecting gait Presence of neurological or cognitive disorders Recurrent pain or ulcer at the stump area S88 Traumatic amputation of lower leg Rehabilitation Rehabilitation Rehabilitation Intervention Group 1: Single-task Exercises, Participants in the first intervention group followed a single-task exercise program. These exercises included balance movements, lower-limb resistance exercises (such as half squats, modified lunges, and leg raises), and stretching exercises, all performed without any accompanying cognitive task. The program was carried out over 8 weeks, three sessions per week, with each session lasting 60 minutes (10 minutes warm-up, 40 minutes main exercises, and 10 minutes cool-down). The exercises were conducted in the rehabilitation hall using simple equipment such as exercise mats, resistance bands, and chairs, under the supervision of the researcher. Intervention Group 2: Dual-task Exercises, Participants in this group, in addition to performing the same motor exercises as Group 1 (balance, resistance, and stretching exercises), simultaneously carried out a simple cognitive task such as backward counting or reciting predetermined words. The aim was to examine the combined effect of physical and cognitive exercises on balance and gait. The program lasted 8 weeks, with three sessions per week, and each session was 60 minutes long (10 minutes warm-up, 40 minutes main exercises integrating motor and cognitive tasks, and 10 minutes cool-down). The exercises were performed in the rehabilitation hall using simple equipment such as exercise mats, resistance bands, and chairs, under the supervision of the researcher. Control group: The control group did not receive any intervention (in this study, it means cognitive and motor exercises). Gait speed. Timepoint: Outcome measurement was performed at two time points: once one week before the intervention and once one week after completion of the eight-week intervention period. Method of measurement: Motion Analysis (Vicon), VERO v2.2 model, made in England. Stride length. Timepoint: Outcome measurement was performed at two time points: once one week before the intervention and once one week after completion of the eight-week intervention period. Method of measurement: Motion Analysis (Vicon), VERO v2.2 model, made in England. Hip range of motion. Timepoint: Outcome measurement was performed at two time points: once one week before the intervention and once one week after completion of the eight-week intervention period. Method of measurement: Motion Analysis (Vicon), VERO v2.2 model, made in England. Knee joint range of motion. Timepoint: Outcome measurement was performed at two time points: once one week before the intervention and once one week after completion of the eight-week intervention period. Method of measurement: Motion Analysis (Vicon), VERO v2.2 model, made in England. Postural control. Timepoint: Outcome measurement was performed at two time points: once one week before the intervention and once one week after completion of the eight-week intervention period. Method of measurement: Force plate (Kistler) model 9260AA made in Switzerland. Quality of life. Timepoint: Outcome measurement was performed at two time points: once one week before the intervention and once one week after completion of the eight-week intervention period. Method of measurement: World Health Organization Quality of Life Questionnaire. The University of Shahid Beheshti Approved 2023-12-23 Ethics committee of Shahid Beheshti University Shahid Shahriari Sq., Evin District, Tehran Tehran Tehran Iran (Islamic Republic of)