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IRCT20241125063846N1 IRCT 2025-02-18 The university of Lahore Effects of core strengthening exercise with and without proprioceptive neuromuscular facilitation on mobility, balance, and coordination Effects of core strengthening exercises with and without proprioceptive neuromuscular facilitation on mobility, balance, and coordination in post stroke hemiplegic patients 2024-06-07 anticipated 62 Complete https://irct.ir/trial/80699 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Lottery method will be used for randomization by an independent statistician. Randomization will be done by one of the research team members who will not involve in patient recruitment or assessment or data analysis. In this method Group names are mentioned on separate slips of paper of same size, shape and color. They will be folded and mixed up in a container. A blind fold selection will be made and each member of the population will be assigned a number. Randomization assignments will be kept in opaque, sealed envelopes and unsealed by a researcher after baseline testing. Outcome assessors will not be unaware of group assignment, Blinding description: Single blinded study in which assessor will be kept unaware of which treatment is given to two groups being studied while participants know about their treatment protocol. N/A Stroke is defined as ‘rapidly developing clinical signs of focal or global disturbance of cerebral function, with symptoms lasting 24 h or longer, or leading to death, with no apparent cause other than of vascular origin ‘Stroke definition includes both cerebral infarction and intracerebral subarachnoid hemorrhage.. Intervention 1: Intervention group A: The participants in Group A were received one-on-one PNF-based therapy lasting for 30 minutes, three times a week, for six weeks (18 treatment sessions). Sessions were divided into resisted mat exercises and resisted walking training.Exercises were repeated 10-15 times up to tolerance. Different PNF techniques were used in response to the participant's needs. Rhythmic initiation (movement of limb or body through the desired range starting with passive motion and progressing to active resisted movement) was used to teach the movements. Stabilizing reversals (alternating isotonic contractions with enough resistance to prevent motion)Dynamic reversals (active motions changing from one direction to the opposite), and combination of isotonics (combined concentric, eccentric and stabilizing contractions of one muscle group) was used to improve the strength and coordination of the movement .Core strengthening exercise: These exercises consisted of 9 basic exercises. In each class, each exercise was held for 10-60 seconds followed by 10-20 seconds of rest as shown in table 2. Repetition was 3-5 times. Intervention 2: Intervention group B: The participants in Group B was received a treatment session 10 minutes of heat therapy and exercises for 10 minutes, then core strengthening exercises were performed as in group B with duration of 30 minutes . Repetition was 3-5 times and other exercises without PNF including pelvic rolling, bridging, sitting and standing exercises and walking practice in parallel bars. Yes - There is a plan to make this available What will be shared: Demographic data and data related to final outcome will be shared by maintaining the confidentially When: Data will be available after the publication of findings till six months To whom: This is available for people working in academic institutions or also for those who are working in clinics. Conditions: Research purpose Where to obtain: To the correspomding author of the study , Amara Rubab and contact on +923032555480 and amararubab@gmail.com How to obtain: Open access and there is the traditional public data release where anyone can get access to the data Comments:
public Amara Rubab
1 km Defence Road , near Bhuptian Chowk , Lahore , Punjab
Lahore Pakistan 55150 +92 303 2555480 amararubab@gmail.com The university of Lahore scientific Amara Rubab
1 km Defence Road , near Bhuptian Chowk , Lahore , Punjab
Lahore Pakistan 55150 +92 303 2555480 amararubab@gmail.com The university of Lahore Pakistan Aged between 40-65 years Both Male and females Stroke Onset ≥3 months Ambulatory with and without aid Patients with Berge balance scale score less than 45 45 years 65 years Both Patients with Cardiopulmonary disease Patients with any type of orthopedic injury Patients with visual and vestibular dysfunction Patients who struggle to follow exercise instructions I63.30 Cerebral infarction due to thrombosis of unspecified cerebral artery Treatment - Other Treatment - Other Intervention group A: The participants in Group A were received one-on-one PNF-based therapy lasting for 30 minutes, three times a week, for six weeks (18 treatment sessions). Sessions were divided into resisted mat exercises and resisted walking training.Exercises were repeated 10-15 times up to tolerance. Different PNF techniques were used in response to the participant's needs. Rhythmic initiation (movement of limb or body through the desired range starting with passive motion and progressing to active resisted movement) was used to teach the movements. Stabilizing reversals (alternating isotonic contractions with enough resistance to prevent motion)Dynamic reversals (active motions changing from one direction to the opposite), and combination of isotonics (combined concentric, eccentric and stabilizing contractions of one muscle group) was used to improve the strength and coordination of the movement .Core strengthening exercise: These exercises consisted of 9 basic exercises. In each class, each exercise was held for 10-60 seconds followed by 10-20 seconds of rest as shown in table 2. Repetition was 3-5 times Intervention group B: The participants in Group B was received a treatment session 10 minutes of heat therapy and exercises for 10 minutes, then core strengthening exercises were performed as in group B with duration of 30 minutes . Repetition was 3-5 times and other exercises without PNF including pelvic rolling, bridging, sitting and standing exercises and walking practice in parallel bars. The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. Timepoint: 6 weeks. Method of measurement: It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait. Cut-off scores for the elderly were reported <45 indicates individuals may be at greater risk of falling. Trunk impairment scale aims to evaluate the trunk in patients who have suffered a stroke. TIS assesses static and dynamic sitting balance and trunk coordination in a sitting position. Timepoint: 6 weeks. Method of measurement: For each item, a 2-, 3- or 4-point ordinal scale is used. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance. The Barthel Index for Activities of Daily Living is an ordinal scale which measures a person's ability to complete activities of daily living (ADL). Each item is scored based on whether or not the individual can perform a task or activity independently, with assistance or if they are fully dependent. Timepoint: 6 weeks. Method of measurement: . The scoring is as follows: 0 = unable, 1 = needs assistance/help, 2 = independent. The for the ten items are summed and x 5 to get a total score out of 100. Proposed guidelines for interpreting Barthel scores are as :1) 0-20 indicate “total” dependency, 2) 21-60 indicate “severe” dependency, 3) 61-90 indicate “moderate” dependency, 4) 91-99 indicate “slight” dependency and most studies use a score of 60/61 (moderate dependency) as a cutting point. The university of Lahore Approved 2024-05-24 Research Ethics Committee of University of Lahore University of Lahore Teaching Hospital Lahore , Punjab , Pakistan Lahore Punjab Pakistan