Effectiveness of Proprioceptive Neuromuscular Exercises in improving Knee Range of Motion, Functional Ability, and Balance in Total Knee Arthroplasty Patients; A Randomized Clinical Trial

To determine the effect of Proprioceptive Neuromuscular Facilitation exercises in improving knee ROM, functional activity and balance in total knee arthroplasty patients.

two arm parallel group randomized trial with patients and data analyzer blinded

The study will be conducted at Physiotherapy department of Rehman Medical Institute, Peshawar. The participants will be blinded by not informing them what group they are in, similarly the statistician will be blinded by keeping the allocation of participants concealed.

Participants who had unilateral total knee replacement surgery 1 week ago and were able to walk for 10 meters on ground at a comfortable speed, and having MMSE score of 24 or more were included in the study while the participants who had total knee replacement previously, re-operation for total knee replacment (revision arthroplasty or manipulation under anesthesia), past surgical history of any orthopedic procedure at lower limbs, history of fractures at lower limbs, multiple medical comorbidities such as metabolic disorders, cancers, cardiovascular conditions, Cognitive and neurological disorders i.e. stroke, neuropathy, neuromuscular disorders and individuals on Beta Blockers and uncontrolled Hypertension were excluded.

Participants in the control group will receive traditional stretching and exercises using isotonic contractions while those in experimental group will be engaged in stretching using PNF techniques such as Rhythmic Initiation, Combination of isotonic and Hold Relax, along with the exercises given to the control group, each for 30 minutes, conducted 5 times a week for 2 weeks.

Knee Range of Motion, Functional activity and Balance are the outcome variables, which are to be assesed via goniometer, time up & go test, and mini berg balance scale.

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.

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.