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IRCT20230907059376N2 IRCT 2023-10-22 Khyber Medical University, Peshawar Effectiveness of core stability exercises on energy expenditure during gait in stroke patients; A randomized controlled trial Effectiveness of core stability exercises on energy expenditure during gait in stroke patients 2023-09-27 anticipated 50 Complete https://irct.ir/trial/73267 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In our trial, randomization will be conducted using a lottery method. The unit of randomization is the individual participant. For each participant, a unique identifier will be assigned, and these identifiers will be placed in separate, opaque, and sealed envelopes. The envelopes will be thoroughly mixed before a neutral third party, who is not involved in the trial, draws an envelope for each participant. The treatment assignment corresponding to the label inside the drawn envelope will determine whether the participant receives core stability exercises or conventional physical therapy program. This method ensures the transparency and fairness of the allocation process, eliminating any potential for selection bias. Allocation concealment will be maintained throughout the trial, as the envelopes will be securely stored and opened only at the time of participant allocation, Blinding description: The Randomized Controlled Trial (RCT) registry is designed to ensure complete blinding of the outcome assessor, guaranteeing the integrity and impartiality of the study's results. By maintaining strict confidentiality protocols and employing a comprehensive masking system, the registry safeguards against any potential biases that may arise from the assessor's knowledge of the intervention groups, thereby enhancing the reliability and credibility of the trial's findings. N/A Brain stem stroke syndrome. Intervention 1: Control group: The control group will receive the Modified Rehabilitation Program (MRP) for stroke patients three times a week, administered by trained physical therapists.The intensity of the MRP for the control group will be adjusted based on the patients' specific functional abilities, focusing on moderate-intensity exercises and activities to facilitate gradual recovery. Each session of the MRP for the control group will last for 30 minutes, ensuring an adequate duration to engage in a variety of tailored therapeutic exercises, functional tasks, and mobility training. The MRP for the control group will encompass a comprehensive range of evidence-based physical therapy techniques, including strength-building exercises, balance and coordination drills, as well as activities targeting range of motion and flexibility, tailored to the individualized needs of stroke patients. Intervention 2: Intervention group: Each participant in experimental group will have to attend a 6-weeks program of core stability exercises with 5 minutes each exercise, 5 days a week along with conventional physical therapy. Core stability exercises includes: 1. Bridging exercises 2. Unilateral pelvic bridging 3. Abdominal drawing in maneuver with leg lifts 4. Curl up. Yes - There is a plan to make this available What will be shared: Effectiveness of core stability exercises on energy expenditure during gait in stroke patients; A randomized controlled trial When: Data will be available after completion of RCT and will be available for 1 year To whom: To all the researchers, students and teachers. Conditions: All the authors registered with Iranian clinical trial registry Where to obtain: Data will be available by emailing the principal author on raheela.naz@rmi.edu.pk How to obtain: Just email the author Comments:
public Raheela Naz
5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa
Peshawar Pakistan 25000 +92 91 5838666 raheela.naz@rmi.edu.pk Rehman Medical Institute, Peshawar scientific Raheela Naz
5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa
Peshawar Pakistan 25000 +92 91 5838666 raheela.naz@rmi.edu.pk Rehman Medical Institute, Peshawar Pakistan Stroke patients between 30 to 55 years of age Both ischemic and hemorrhagic stroke Patients who experienced a single stroke. Patients who can walk for 10 minutes on ground at a comfortable speed(with or without assistive device) Patients having MMSE score of 24 or more. 30 years 55 years Both Patients who has cerebellar and pontine stroke. Patients who has orthopedic problems. Patients who have vertigo, dizziness, angina or resting heart rate is not between 40-100bpm range. Patients who cannot follow instructions given by the therapist G46.3 Brain stem stroke syndrome Rehabilitation Rehabilitation Control group: The control group will receive the Modified Rehabilitation Program (MRP) for stroke patients three times a week, administered by trained physical therapists.The intensity of the MRP for the control group will be adjusted based on the patients' specific functional abilities, focusing on moderate-intensity exercises and activities to facilitate gradual recovery. Each session of the MRP for the control group will last for 30 minutes, ensuring an adequate duration to engage in a variety of tailored therapeutic exercises, functional tasks, and mobility training. The MRP for the control group will encompass a comprehensive range of evidence-based physical therapy techniques, including strength-building exercises, balance and coordination drills, as well as activities targeting range of motion and flexibility, tailored to the individualized needs of stroke patients. Intervention group: Each participant in experimental group will have to attend a 6-weeks program of core stability exercises with 5 minutes each exercise, 5 days a week along with conventional physical therapy. Core stability exercises includes: 1. Bridging exercises 2. Unilateral pelvic bridging 3. Abdominal drawing in maneuver with leg lifts 4. Curl up. Physiological cost index. Timepoint: Pre assessment will be done on baseline assessment and Post assessment will be done after 6 weeks. Method of measurement: Physiologic cost index(PCI) is an indicator of energy expenditure that includes heart rate during gait along with speed and the formula used will be energy expenditure: walking heart rate-resting heart rate/walking velocity. Khyber Medical University, Peshawar Approved 2023-10-20 KMU AS&RB 5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa Peshawar Khyber Pakhtunkhwa Pakistan