Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07402447

Effect of Combined Quadriceps and Calf Strengthening Program on Gait in Knee Osteoarthritis Patients

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hayatabad Medical Complex

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location contact

Aisha Razzaq, PHD*

CONTACT

[email protected]

03015030784

Sarah Rehman, MSPT

PRINCIPAL_INVESTIGATOR

About this study

Knee osteoarthritis (KOA) is a chronic, progressive degenerative condition commonly affecting older adults and is a major cause of disability. It is characterized by degeneration of articular cartilage, subchondral bone changes, and synovial inflammation. KOA results in pain, stiffness, impaired balance, reduced physical function, and diminished quality of life, leading to significant psychological and socioeconomic burden. Knee osteoarthritis (KOA) develops due to several factors including mechanical stress, obesity, joint injury, aging-related cartilage wear and tear, genetic predisposition, and low-grade inflammation that damages the cartilage.

Physical therapy is a key component of KOA management and focuses on pain reduction, restoration of joint mobility, and improvement in functional ability and quality of life through exercises such as quadriceps strengthening, gait and balance training, and aerobic or aquatic exercises. Quadriceps strengthening helps stabilize the knee joint, reduce abnormal loading, and improve shock absorption, thereby decreasing joint stress during daily activities.

In addition to quadriceps weakness, patients with KOA commonly exhibit reduced calf muscle strength compared to healthy individuals. The calf muscles, particularly the gastrocnemius, play an important role in knee stabilization, load absorption, and functional movements such as walking. Altered gastrocnemius activation during weight-bearing activities can negatively affect knee biomechanics and contribute to disease progression. Muscle strengthening exercises have been shown to improve muscle strength, balance, and reduce joint inflammation in KOA patients.

Literature review: In a study carried out by Paul DeVita et al in 2018 weaker quadriceps increased the risk and progression of KOA, while strengthening the quadriceps improves pain, physical function, and quality of life by providing better knee stability and reducing joint stress.

A 2020 study by Ali M. Alshami et al. reported that compared to healthy adults, calf muscle weakness and atrophy is common in patients with KOA, with muscle strength notably decreased despite flexibility and girth not being significantly affected to be.

Zhanliang Tan et al in 2025 stated that HKE targeting gastronomies muscle effectively and safely alleviated knee pain and restored function.

A systemic review by Disha D hedge et al in 2025 states that Quadriceps strengthening as a part of lower extremity strengthening is effective in reducing pain in KOA. Emine Kiyak (2018) reported that about 81% of KOA patients significant difficulties in maintaining sleep. Patients with KOA suffered from night pain, which significantly disrupted sleep and contributed to poorer overall sleep quality, ultimately diminishing quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Ability to understand and comply with exercise instructions.

Exclusion criteria

  • 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.
  • Participation in other physiotherapy or pharmacological interventions for knee OA during the study period.
  • Cognitive impairment or inability to follow commands

Treatment and study plan

Group A (Combined Quadriceps and Calf Strengthening)

Other

During 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

During 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.

Primary outcomes

  1. Temporo-spatial Gait

    Time frame: from baseline to 6 weeks

    Gait parameters will be measured by Kinovea Software.A video of the gait will be recorded and then evaluated with kinovea.

  2. Quadriceps Strength

    Time frame: from baseline to 6 weeks

    the Hand Held Dynamometer will be used to asses the strength of quadriceps

  3. Calf Strength

    Time frame: from baseline to 6 weeks

    the Hand Held Dynamometer will be used to asses the strength of Calf

Secondary outcomes

  1. Knee Pain

    Time frame: from baseline to 6 weeks

    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".

  2. knee Disability

    Time frame: from baseline to 6 weeks

    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.

  3. knee Function

    Time frame: from baseline to 6 weeks

    Time up and Go test will be used, TUG is an easy and quick test to assess the patient's functional mobility

  4. Sleep Quality

    Time frame: from baseline to 6 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Aisha Razzaq, PHD

CONTACT

[email protected]

03015030784

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effect of Combined Quadriceps and Calf Strengthening Program on Gait, Functionality, and Sleep Quality in Knee Osteoarthritis Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.