]>
IRCT20190328043131N1 IRCT 2019-08-03 University of Lahore Effect of Whole Body Vibration in Treatment of Stroke Patients WBVT Effect of Whole Body Vibration on Functional Performance and Balance of Chronic Stroke Patients 2017-11-01 anticipated 64 Complete https://irct.ir/trial/38832 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants were divided into two groups by random computer number generator method using the sequence generated list and the allocation was kept concealed, Blinding description: The outcome assessor was a third person in our study who remained blind about the allocation of the groups. The participants who met the inclusion criteria were sent to the outcome assessor who took the initial assessment. Participants received treatment and post-interventional assessment was again carried out by the outcome assessor. The outcome assessor was aware of the patient id only while the participants, principle investigator, care providers, data collectors, and the data safety and monitoring board were aware of the allocation. N/A Patients suffering from Stroke who feel difficulty in performing activities of daily living, especially walking and obstacle clearance capacity due to spasticity in muscle groups of lower extremities.. Intervention 1: Intervention group: WBV Group received routine physiotherapy treatment plus WBV session for 2 weeks. During the intervention, subjects were positioned on the platform in a standing position with both knees extended[0 degree as the anatomic position] to keep an upright position with even weight distribution on both feet. The time course included 5 bouts of 2 minutes of vibration with a 1-minute rest interval between every two steps making the total time duration of 15 minutes with a frequency of 20-30 Hz and a vibration amplitude of 3-6 mm for 6 days per week for 2 weeks. The vertical type of vibratory stimulus was used. In front of the subject was a wall bar that could be grabbed if he/she had to fall. Intervention 2: Control group: Routine Physiotherapy Group received Strengthening Exercises, Stretching Exercises, Gait Training and Balancing Exercises. Yes - There is a plan to make this available What will be shared: Effect Of Whole Body Vibration on Functional Performance and Balance of Chronic Stroke Patients When: Data will be available when my Ph.D. study will complete. To whom: For academic institutions only. Conditions: People who will request for data. Where to obtain: Through Email which is as follows: burq802@yahoo.com How to obtain: Send a request through email to assess data which would be provided within a month. Comments:
public Syed Ijaz Ahmed Burq
Defense Road, Near Bhuptian Chowk,
Lahore Pakistan 53720 +92 42 35322501 burq802@yahoo.com University of Lahore scientific Syed Ijaz Ahmed Burq
Defense Road, Near Bhuptian Chowk,
Lahore Pakistan 53720 +92 42 35322501 burq802@yahoo.com University of Lahore Pakistan Gender of participants should be male or female. Age of the participants should lie between 40 to 75 years. Participants should have their first ever stroke more than 6 months ago. Participants should be medically stable. Participants should have the ability to stand independently with or without aids for at least 20 minutes. Participants should be able to perform the experimental treatment independently. 40 years 75 years Both Participants having acute thrombotic diseases, severe cardiovascular diseases or a pacemaker. Participants having an acute hernia or diabetes. Participants having brain tumors, Parkinson’s disease, multiple sclerosis, epilepsy, peripheral neuropathy or migraine. Participants having rheumatoid arthritis, arthrosis, osteoarthritis, diskopathy or spondylosis. G81.9 Hemiplegia, unspecified Rehabilitation Rehabilitation Intervention group: WBV Group received routine physiotherapy treatment plus WBV session for 2 weeks. During the intervention, subjects were positioned on the platform in a standing position with both knees extended[0 degree as the anatomic position] to keep an upright position with even weight distribution on both feet. The time course included 5 bouts of 2 minutes of vibration with a 1-minute rest interval between every two steps making the total time duration of 15 minutes with a frequency of 20-30 Hz and a vibration amplitude of 3-6 mm for 6 days per week for 2 weeks. The vertical type of vibratory stimulus was used. In front of the subject was a wall bar that could be grabbed if he/she had to fall. Control group: Routine Physiotherapy Group received Strengthening Exercises, Stretching Exercises, Gait Training and Balancing Exercises. Stair Negotiation time. Timepoint: Before Intervention and 2 weeks after intervention. Method of measurement: Stairs Negotiation Time will be measured using a stopwatch as it is time taken to climb up and down three standard stair steps. Obstacle Clearance measurements [Obstacle height that patient can clear without tripping]. Timepoint: Before Intervention and 2 weeks after intervention. Method of measurement: Obstacle Clearance will be measured using 8 obstacles of different height and depth. Berg Balance Scale. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Berg Balance Scale constitutes 14 different activities. Each item is scored along a 5-point scale, ranging from 0 to 4, each grade with well-established criteria. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Modified Ashworth Scale. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: The Modified Ashworth scale measures resistance during passive soft-tissue stretching by scoring according to change in muscle tone ranging from 0 to 4. 0 for no increase in muscle tone, 1 for slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension, 1+ for slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion, 2 for more marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved, 3 for considerable increase in muscle tone, passive movement difficult and 4 for affected part(s) rigid in flexion or extension. Timed Up and Go Test. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: The patient starts in a seated position. The patient stands up upon therapist’s command, walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. The subject is allowed to use an assistive device. 10-Meter Walk Test. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Individual walks 10 meters without assistance and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration. Start timing when the toes of the leading foot crosses the 2-meter mark and stop timing when the toes of the leading foot crosses the 8-meter mark. Assistive devices can be used but should be kept consistent. It is performed at preferred walking speed and the fastest speed possible. Collect three trials and calculate the average of the three trials. University of Lahore Approved 2017-06-13 Institutional Review Board, University of Lahore Raiwind Road, Sultan Town, Lahore Punjab Pakistan