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IRCT20241230064219N1 IRCT 2025-05-11 Khyber Medical University Peshawar Effectiveness of Proprioceptive Neuromuscular Exercises in patients that have undergone Total Knee Replacement Surgery Effectiveness of Proprioceptive Neuromuscular Exercises in improving Knee Range of Motion, Functional Ability, and Balance in Total Knee Arthroplasty Patients; A Randomized Clinical Trial 2025-05-15 anticipated 32 Complete https://irct.ir/trial/81068 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization will be conducted to ensure unbiased allocation of participants into study groups. The method of randomization employed will be block randomization, which will help maintain equal group sizes throughout the enrollment period. The unit of randomization will be individual participants, allowing for precise control over group characteristics. To enhance balance across key baseline variables, stratified randomization will be implemented. Randomization strata will be based on factors such as age group and gender, ensuring that these characteristics are evenly distributed between the intervention and control groups. The randomization process will be carried out using computer software designed for clinical trials, i.e. random.org, which can generate a reproducible and tamper-proof sequence. The random sequence will be generated in advance using a pre-defined algorithm within the software, ensuring unpredictability and integrity in the allocation process. To protect against selection bias, allocation concealment will be maintained throughout the process. This will be achieved using sealed, opaque, and sequentially numbered envelopes, which will be prepared and opened only after the participant has been enrolled in the study, Blinding description: This study will adopt a double-blind design, in which both the participants and the outcome assessor will be blinded to group allocation. Participants will not be informed of whether they are receiving the experimental intervention or the control condition. To support this, both interventions will be matched in terms of appearance, duration, and general format, thereby minimizing the chances that participants could infer their group allocation based on the nature of the treatment received. All instructions and interactions will be standardized across groups. The assessor, responsible for collecting both pre-intervention and post-intervention data, will remain fully blinded to the group assignment of each participant. The assessor will not participate in intervention delivery, will not have access to the randomization list or allocation codes, and will interact with participants only during scheduled data collection sessions i.e. at the start of the intervention and two weeks after the intervention is given. All participants will be identified by coded IDs, and documents of data collection will be anonymized to avoid revealing group identity. To further ensure the maintenance of blinding, participants will be explicitly instructed not to disclose any information about their intervention to the assessor during the data collection process. In addition, separate personnel will handle randomization and intervention delivery to prevent information leakage. To evaluate the effectiveness of blinding, a post-study assessment of blinding integrity will be conducted. The assessor will be asked to guess participants' group assignments to determine whether blinding was preserved throughout the study. Any cases of suspected or actual unblinding will be recorded, along with their potential impact on study results. 3 The condition under study is knee osteoarthritis. Systematic analysis for a Global burden of disease study done in 2021, shows that OA was the 7th ranked cause of Years lost due to disability (YLD’s) in adults aged over 70 years and knee was the most common site of Osteoarthritis. While the post-operative recovery process differs from person to person, most of the patients report a marked improvement in the outcomes such as pain however, it has been found that muscle atrophy, neuromuscular impairments and balance deficits can persist for longer periods of time as indicated in a systematic review conducted by Ravi et.al. Post-operative mobility is strongly influenced by knee range of motion (ROM). A reduction in knee ROM not only weakens lower extremity muscle strength over time but also causes joint stiffness.. Intervention 1: Control group: Participants in the control group will receive exercises such as (1) knee flexion with assistance from a belt in supine lying, (2) quadriceps on fulcrum in supine lying, (3) heel slides in supine lying (4) straight leg raise in hooked lying (5) knee extension with assistance from a belt in hook lying, (6) seated knee extension, and (7) Seated Knee flexion while sliding the foot on the ground using isotonic contractions. These exercises will be performed under the supervision of a skilled physical therapist in a physical therapy OPD setting, for a duration of 30 minutes, with exercise sessions conducted 5 times a week for 2 weeks. Intervention 2: Interventional Group: Participants in the Experimental or interventional group will receive same exercises given to the control group but these exercises will be performed using techniques of Proprioceptive Neuromuscular facilitation called Rhythmic Initiation (RI), Combination of isotonic (CI) and Hold Relax (HR). Exercises such as (1) knee flexion with assistance from a belt in supine lying, (2) quadriceps on fulcrum in supine lying, (3) heel slides in supine lying (4) straight leg raise in hooked lying (5) knee extension with assistance from a belt in hook lying, (6) seated knee extension, and (7) Seated Knee flexion while sliding the foot on the ground will be performed in a manner that each exercise position is held for 10 seconds with a rest period of 10 seconds. Each exercise will have 2 sets and each set will have 6 repetitions and a time period of 1 minute as rest between each set. The exercise sessions will be conducted 5 times a week for 2 weeks under the supervision of a skilled physical therapist in a physical therapy OPD setting. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further infromation
public Munazza Shah
D-2, PTCL Colony opposite Bagh-e-Naran, sector k-2, phase 3 Hayatabad Peshawar
Peshawar Pakistan 25000 +92 91 5812299 shah.munazza997@gmail.com Institute of Physical Medicine and Rehabilitation, Khyber Medical University scientific Munazza Shah
D-2, PTCL Colony opposite Bagh-e-Naran, sector k-2, phase 3 Hayatabad Peshawar
Peshawar Pakistan 25000 +92 91 5812299 shah.munazza997@gmail.com Institute of Physical Medicine and Rehabilitation, Khyber Medical University Pakistan Individuals with unilateral Total Knee Arthroplasty Procedure Participants who underwent 1 weeks after Total Knee Arthroplasty surgery Patients who can walk for 10 meters on ground at a comfortable speed (with or without assistive device) Patients having Mini Mental State Examination score of 24 or more no limit no limit Female Individuals who had undergone total knee replacement previously. Individuals who had a re-operation for total knee arthroplasty (revision arthroplasty or manipulation under anesthesia). Past surgical history of any orthopedic procedure at lower limbs. History of fractures at lower limbs. Individuals with multiple medical comorbidities such as metabolic disorders, cancers. Individuals with cardiovascular conditions such as Ischemic heart disease or Peripheral Vascular Disease. Individuals with Cognitive and neurological disorders i.e. stroke, neuropathy. Individual with neuromuscular disorders i.e., Multiple Sclerosis. Individuals on Beta Blockers and uncontrolled Hypertension. Individuals with multiple musculoskeletal conditions other than knee Osteoarthritis M17 Osteoarthritis of knee Treatment - Other Treatment - Other Control group: Participants in the control group will receive exercises such as (1) knee flexion with assistance from a belt in supine lying, (2) quadriceps on fulcrum in supine lying, (3) heel slides in supine lying (4) straight leg raise in hooked lying (5) knee extension with assistance from a belt in hook lying, (6) seated knee extension, and (7) Seated Knee flexion while sliding the foot on the ground using isotonic contractions. These exercises will be performed under the supervision of a skilled physical therapist in a physical therapy OPD setting, for a duration of 30 minutes, with exercise sessions conducted 5 times a week for 2 weeks Interventional Group: Participants in the Experimental or interventional group will receive same exercises given to the control group but these exercises will be performed using techniques of Proprioceptive Neuromuscular facilitation called Rhythmic Initiation (RI), Combination of isotonic (CI) and Hold Relax (HR). Exercises such as (1) knee flexion with assistance from a belt in supine lying, (2) quadriceps on fulcrum in supine lying, (3) heel slides in supine lying (4) straight leg raise in hooked lying (5) knee extension with assistance from a belt in hook lying, (6) seated knee extension, and (7) Seated Knee flexion while sliding the foot on the ground will be performed in a manner that each exercise position is held for 10 seconds with a rest period of 10 seconds. Each exercise will have 2 sets and each set will have 6 repetitions and a time period of 1 minute as rest between each set. The exercise sessions will be conducted 5 times a week for 2 weeks under the supervision of a skilled physical therapist in a physical therapy OPD setting. Range of Motion: The knee flexion and extension Range of Motion. Timepoint: before intervention and 2 weeks after intervention. Method of measurement: Range of Motion will assessed using a goniometer with patient in supine position and in saggital plan of movement. Secondary outcome variable is Functional Activity. Being bed ridden in the initial phases after total knee replacement detrimentally effects the level of functional activity as many patients avoid to move at all. Timepoint: before intervention and 2 weeks after intervention. Method of measurement: The Timed Up and Go (TUG) test will be used to assess functional activity. It is a highly reliable tool with inter- and intra-rater reliability scores of r=0.98 to 0.99. At the starting point, participants will be seated in an chair. When the signal to begin is given, they must get up from the chair, move three meters to a point, quickly turn towards the TKR side, and then get back in the chair. The time to complete the task will be recorded. Balance. Timepoint: before intervention and 2 weeks after intervention. Method of measurement: Short form of Berg Balance scale will be used to assess the balance performance of the participants. Khyber Medical University Peshawar Approved 2024-11-08 Ethics Committee of Institute of Physical Medicine and Rehabilitation, Khyber Medical University Phase V, Hayatabad, Peshawar Peshawar Khyber Pakhtunkhwa Pakistan