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IRCT20211011052727N3 IRCT 2023-04-10 Khyber Medical University Effectiveness of motor imagery on hemiplegic gait and walking energy cost in sub-acute stroke patients Effectiveness of motor imagery on hemiplegic gait and walking energy cost in sub-acute stroke patients 2023-04-15 anticipated 32 Complete https://irct.ir/trial/64500 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After meeting the inclusion criteria and giving a written informed consent, a total of 44 patients will be enrol in this study. These participants will be randomly allocated into two groups namely; the Experimental group (motor imagery along with conventional therapy) and the Control group (conventional therapy only). The random allocation will be performed by using sealed envelope (opaque). Total 44 envelopes will be made, 22 will be having a paper with group A (control group) written on it and 22 will have group B (experimental group). This will be for equal distribution of subjects in the two groups. Each participant will be asked to pick an envelope and will handed over to the researcher. Participants will not be blinded about their allocation. All the participants will be inform about the goals and intervention of the study by providing details, Blinding description: The outcome assessor who will be recording the outcome scores will be blinded he will not be aware weather the participant was in control group or experimental one. N/A Stroke rehabilitation. Intervention 1: "Intervention group:" All the recruited patients in the interventional group will start each session with a mental rehearsal of the motor imagery technique for 15 minutes followed by 30 minutes of conventional physical therapy techniques including gait training exercises and Neuro-developmental techniques each session will last for 45 minutes. The patients will attend 3 sessions per week for a total of 6 weeks. The patient's baseline assessment includes walking speed, resting heart rate, oxygen saturation, and walking energy cost will be calculated using the physiological cost index. Intervention 2: Control group: Patients in the control group will attend 45 minutes of conventional physical therapy techniques including gait training exercises and Neuro-developmental techniques each session will last for 45 minutes. The patients will attend 3 sessions per week for a total of 6 weeks. At the end of 6 weeks patient walking energy cost will be calculated by a blinded assessor. No - There is not a plan to make this available Justification or reason for not sharing IPD is as this is the first trail on this case the initial plan is not to disclose it in the beginning.
public Salman Farooqi
264 F6, phase 6 hayatabad
Hayatabad peshawar Pakistan 25001 +92 91 5823496 Salman.farooqi@email.rmi.edu.pk Khyber Medical University scientific Salman Farooqi
264 F6, Phase 6 Hayatabad
Hayatabad Peshawar Pakistan 25001 +92 91 5823496 salman.farooqi@kmu.edu.pk Khyber Medical University Pakistan Mini mental state examination score>24 Modified ashworth scale score>3 Manual muscle testing >3 Age between 40 - 75 40 years 75 years Both Other neurological disorder excluded unstable acute stroke patient Unilateral neglect Cardiovascular patient Cardiovascular patient With evidence of flaccidity G81 Hemiplegia and hemiparesis Rehabilitation Rehabilitation "Intervention group:" All the recruited patients in the interventional group will start each session with a mental rehearsal of the motor imagery technique for 15 minutes followed by 30 minutes of conventional physical therapy techniques including gait training exercises and Neuro-developmental techniques each session will last for 45 minutes. The patients will attend 3 sessions per week for a total of 6 weeks. The patient's baseline assessment includes walking speed, resting heart rate, oxygen saturation, and walking energy cost will be calculated using the physiological cost index. Control group: Patients in the control group will attend 45 minutes of conventional physical therapy techniques including gait training exercises and Neuro-developmental techniques each session will last for 45 minutes. The patients will attend 3 sessions per week for a total of 6 weeks. At the end of 6 weeks patient walking energy cost will be calculated by a blinded assessor. Physiological cost index. Timepoint: the outcome will be checked pre intervention then on 2nd and 4th week after intervention and finally on 6th week post intervention. Method of measurement: the formula to calculate the physiological cost index is exercising heart rate minus resting heart rate divided by walking velocity. ( heart rate will be recorded using a pulse oximeter and walking velocity will be measured using 6-meter walk test). Khyber Medical University Approved 2022-06-20 Institutionl ethical review committee. Institute of Physical Medicien and rehabilitation Khyber Medi Hayatabad phase 5 Peshawar Khyber pukhtoonkhwa Pakistan