Actively Recruiting

Phase Not Applicable
Age: 60Years +
FEMALE
ID05642260

The Short- and Long-term Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement: a Pragmatic Single-blinded Randomized Controlled Trial

Led by Ministry of Health, Kuwait · Updated on 2025-12-09

90

Participants Needed

1

Research Sites

22 weeks

Total Duration

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AI-Summary

What this Trial Is About

This research aims to study the short- and long-term effects of adding a comprehensive fall prevention program to regular physiotherapy for elderly women who have undergone total knee replacement (TKR) due to osteoarthritis. It focuses on reducing the number of falls, improving balance, and enhancing functional ability. The study is a single-blinded, randomized controlled trial lasting 24 weeks, involving older adults treated at Al-Razi Orthopedic Hospital. Participants will be divided into two groups. The control group will receive conventional physiotherapy that includes exercises to improve blood circulation, strengthen muscles, increase knee range of motion, and gait training. The experimental group will receive the same physiotherapy plus a fall prevention program featuring Otago balance exercises, personalized advice on assistive devices based on balance scores, environmental hazard checks, and guidance on vision care and footwear. Both groups will follow a home exercise program. During the study, participants will be monitored for falls at baseline, 12 weeks, and one year. Assessments will include knee range of motion and patient satisfaction at 12 weeks and one year. Adherence to the exercise programs will also be tracked. The trial aims to evaluate how well the combined treatment improves outcomes compared to physiotherapy alone, with safety and functional recovery closely observed throughout the study period.

CONDITIONS

Brief Title

Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement

Who Can Participate

Age: 60Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female gender
  • Aged 60 years and older
  • Diagnosed with primary osteoarthritis of the knee
  • Underwent unilateral total knee replacement (TKR) surgery
Not Eligible

You will not qualify if you...

  • Revision total knee replacement surgery
  • History of systemic inflammatory conditions such as rheumatoid arthritis or lupus erythematosus
  • Neurological disorders including multiple sclerosis, Parkinson's disease, or stroke
  • Lower limb surgery or trauma in the past 12 months
  • Cognitive or vision impairments
  • Post-surgical complications such as infection or intraoperative fracture
  • Any health condition that prevents undertaking physiotherapy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive conventional physiotherapy treatment following total knee replacement. Those in the experimental group also receive a comprehensive fall prevention program integrated into their physiotherapy, including balance exercises and individualized advice.

Weekly visits for up to 12 weeks

Follow-up

Duration - Up to 1 year

Participants are monitored for long-term effects on fall rates, knee range of motion, satisfaction, and adherence after the treatment period.

1 visit at 12 weeks and 1 visit at 1 year

Trial Site Locations

Total: 1 location

1

Alrazi orthopedic hospital

Kuwait City, Kuwait

Actively Recruiting

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Research Team

H

Hadeel H Alsaleh, PhD

E

Eman Y Merza, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

The short- and long-term effects of a fall prevention program on the frequency of falls following total knee replacement: A pragmatic single-blinded randomized controlled trial protocol.

Hadeel Al-Saleh, Eman Merza, Bader Al-Adwanie...

https://pubmed.ncbi.nlm.nih.gov/39921156