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IRCT20210830052336N1 IRCT 2021-09-06 Riphah international university Single Blind, randomized controlled clinical trial EFFECTS OF PLANTER VIBRATION ON BALANCE AND POSTURAL INSTABLITY IN CHRONIC STROKE PATIENTS 2021-06-02 anticipated 36 Complete https://irct.ir/trial/58405 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects will be randomly divided into 2 groups (control group A and experimental group B) by coin toss method using convenient sampling technique and informed consent will be taken from each patient who willing to participate in the study, Blinding description: participant will be blinded. N/A Patients suffering from Stroke who feel difficulty in performing activities of daily living.. Intervention 1: Control group:. Intervention 2: Intervention group:. Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure only When: After the publication of the study. To whom: academic institutions and researchers Conditions: On informed request from the investigators Where to obtain: by email How to obtain: on email request, data will be provided . Comments:
public Yaser Majeed
Railway Carriage Factory Rd, Railway Scheme 7
Islamabad Pakistan 46000 +92 51 4509595 yasirmajeed216@gmail.com Riphah International University scientific Yaser Majeed
Railway Carriage Factory Rd, Railway Scheme 7
Islamabad Pakistan 46000 +92 51 4509595 yasirmajeed216@gmail.com Riphah International university Pakistan Age of the participants between 40 to 70 years Participants who have their first ever stroke ≥ 6 months ago Participants who are medically stable Able to walk without use of walking aids Rankin Modified Scale 4 score Able to understand verbal commands. 40 years 70 years Both Participation in other treatment protocols for balance Presence of other neurological or musculoskeletal conditions affecting balance History of fracture or lower-limb surgery within the 12 months Patients having vestibular, visual or auditory disorders Abnormal synergies, fixed ankle contractures Uncontrolled diabetes or hypertension Use of medication that may affect balance Unwillingness for participation in the study G46.4 Cerebellar stroke syndrome Rehabilitation Rehabilitation Control group: Intervention group: Berg Balance Scale. Timepoint: Before intervention and after six weeks of 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. The Modified of the Postural Assessment Scale for Stroke Patients (PASS). Timepoint: Before intervention and weeks after intervention. Method of measurement: It consists of a 4-point scale where the items are scored from 0 to 3, and the total scoring ranges from 0 to 36. Stroke Specific Quality of Life Scale (SS-QOL). Timepoint: Before intervention and weeks after intervention. Method of measurement: The Stroke Specific Quality of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke. Scoring: each item shall be scored with the following key Total help - Couldn't do it at all - Strongly agree (1), A lot of help - A lot of trouble - Moderately agree (2), Some help - Some trouble - Neither agree nor disagree (3), A little help - A little trouble - Moderately disagree (4) No help needed - No trouble at all - Strongly disagree (5). Riphah international university Approved 2021-05-11 Research ethical Committee, Riphah College of Rehabilitation Sciences Islamabad Riphah International University Islamabad City Campus 7th Avenue, Sector G-7/4, Islamabad Islamabad Punjab Pakistan