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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorRiphah International University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Group A (Combined Quadriceps and Calf Strengthening)

    Other intervention

    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 intervention

    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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Group A (Combined Quadriceps and Calf Strengthening)Experimental treatment 1 intervention
Group B: Group B (Conventional)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Temporo-spatial Gait

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

Time frame
from baseline to 6 weeks
2

Quadriceps Strength

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

Time frame
from baseline to 6 weeks
3

Calf Strength

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

Time frame
from baseline to 6 weeks

Secondary outcomes

1

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".

Time frame
from baseline to 6 weeks
2

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.

Time frame
from baseline to 6 weeks
3

knee Function

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

Time frame
from baseline to 6 weeks
4

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

Time frame
from baseline to 6 weeks

Other outcomes

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