About this trial
The aim of this study is to determine the effects of a combined quadriceps and calf strengthening program on gait, strength, pain, disability, functional mobility, and sleep quality in patients with knee osteoarthritis. A randomized controlled trial will be conducted at Hayatabad Medical Complex, Peshawar. A total of 52 participants aged 40-60 years with grade 2-3 knee osteoarthritis will be recruited using non-probability convenience sampling and randomly allocated into experimental and control groups. Outcome measures include Kinovea software for gait analysis, hand-held dynamometer for strength, Numeric Rating Scale for pain, WOMAC for disability, Timed Up and Go test for function, and Pittsburgh Sleep Quality Index for sleep quality. Data will be analyzed using SPSS version 27 employing repeated measures ANOVA and mixed-way ANOVA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Both Male and Female
Participants aged 40-60years.
Diagnosed with grade 2 and 3 of knee osteoarthritis according to Kellgren-Lawrence
Quads manual muscle grading <4
Disqualifiers
History of recent knee surgery or trauma in the past six months.
Inflammatory joint diseases (e.g., rheumatoid arthritis, gout).
Severe cardiovascular or neurological disorders.
Uncontrolled hypertension or diabetes.
Trial design
Parallel
Treatments tested in this trial
Group A (Combined Quadriceps and Calf Strengthening)
Other interventionDuring weeks 1-2, Group A will receive a heating pad for 10 minutes followed by Grade II joint mobilization. This will be followed by strengthening exercises including quadriceps strengthening in the form of straight leg raises, quadriceps sets, and leg extension exercises with 1 kg weight. Calf strengthening exercises will also be performed, including standing heel raises, seated calf raises, and standing single heel raises with support. All exercises will be initially performed with 10 repetitions and 1 set. During weeks 3-4, the exercise protocol will progress by increasing the repetitions to 12, sets to 2, and external resistance to 1.5 kg. During weeks 5-6, further progression will be made by increasing the repetitions to 15, sets to 3, and external resistance to 2 kg.
Group B( Conventional)
Other interventionDuring weeks 1-2, Group B will receive a heating pad for 10 minutes followed by Grade II joint mobilization. This will be followed by quadriceps strengthening in the form of straight leg raises, quadriceps sets, and leg extension exercises with 1 kg weight. All exercises will be initially performed with 10 repetitions and 1 set. During weeks 3-4, the exercise protocol will progress by increasing the repetitions to 12, sets to 2, and external resistance to 1.5 kg. During weeks 5-6, further progression will be made by increasing the repetitions to 15, sets to 3, and external resistance to 2 kg.
Treatment groups
Trial outcomes
Primary outcomes
Temporo-spatial Gait
Gait parameters will be measured by Kinovea Software.A video of the gait will be recorded and then evaluated with kinovea.
Quadriceps Strength
the Hand Held Dynamometer will be used to asses the strength of quadriceps
Calf Strength
the Hand Held Dynamometer will be used to asses the strength of Calf
Secondary outcomes
Knee Pain
Pain will be assessed using Numeric Rating Scale(NRS). it is an 11-point scale comprising a number from 0 through 10; 0 indicates "no pain", and 10 indicates the "worst imaginable pain".
knee Disability
it will be assessed using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), . It consists of 24 items in subscale measuring pain, stiffness and physical function.
knee Function
Time up and Go test will be used, TUG is an easy and quick test to assess the patient's functional mobility
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. the PSQI measures seven domains of sleep quality: subjective sleep quality, sleep latency (time to fall asleep initially), sleep duration, sleep efficiency (percent of time in bed spent asleep), sleep disturbances, use of sleep medications, and daytime dysfunction
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