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

NCT05642260 | Recruiting DMC

• 1 other identifier: 2146/2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of the proposed research is to investigate the short and long-term effects of integrating a comprehensive fall prevention programme into conventional physiotherapy on the number of falls, balance, and functional ability among elderly following TKR. the investigator hypothesize that conventional physiotherapy integrated with a fall prevention program is more effective than conventional physiotherapy alone in improving balance and functional ability and preventing the occurrence of falls among elderly following TKR. Study type: The proposed study is a parallel group prospective (24 weeks) randomised single-blinded pragmatic controlled trial. Participants: Older adults operated for TKR at Al-Razi orthopedic hospital, who met the inclusion criteria.

Conditions

Fall; Osteo Arthritis Knee; Total Knee Replacement

Keywords

fall; older people; fall prevention; TKR; rehabilitation

Outcome Measures

Primary Outcomes (3)

• falls rate

  The primary outcome measure in this trial will be the number of reported falls during the study period.The patients will be given a falls' diary to record the number of falls (if any), time of falling (e.g., early morning or late night), and the cause of falling (e.g., slippery floor, dizziness, tripping over).

  baseline

• falls rate

  The primary outcome measure in this trial will be the number of reported falls during the study period.The patients will be given a falls' diary to record the number of falls (if any), time of falling (e.g., early morning or late night), and the cause of falling (e.g., slippery floor, dizziness, tripping over).

  12 weeks

• falls rate

  The primary outcome measure in this trial will be the number of reported falls during the study period.The patients will be given a falls' diary to record the number of falls (if any), time of falling (e.g., early morning or late night), and the cause of falling (e.g., slippery floor, dizziness, tripping over).

  1 year

Secondary Outcomes (6)

• Knee range of motion (ROM)

  baseline

• Knee range of motion (ROM)

  12 weeks

• Patient's satisfaction

  12 weeks

• Patient's satisfaction

  1 year

• Adherence:

  12 weeks

Other Outcomes (5)

• Numerical Pain Rating Scale NPRS

  baseline, 12 weeks, 1 year

• 10-meter walk test

  baseline, 12 weeks

• Timed Up and Go test

  baseline, 12 weeks

Study Arms (2)

control group

NO INTERVENTION

Patients in the control group will receive a conventional physiotherapy treatment (guided by the post-TKR protocol followed at Al-Razi Orthopedic Hospital). The treatment will be delivered by four allocated physiotherapists,The treatment will be delivered by four allocated physiotherapists, and will consist of: 1. Blood circulation exercise (i.e., ankle pumps) 2. Quadriceps isometric exercises (i.e., quad sets). 3. Knee ROM exercises (i.e., knee flexion and extension). 4. Lower limb strengthening exercises (e.g., straight leg raising, short/ long arch exercises) 5. Stretching exercises for the hamstring and calf muscles. 6. Gait training (with and without the assistive device). 7. Parallel bars exercises (e.g., standing hip abduction/adduction, knee flexion, squatting). 8. Ascending/descending stairs. 9. Home program.

intervention (treatment) group

EXPERIMENTAL

Patients in the experimental group will receive a comprehensive fall prevention program (described below) integrated into the conventional physiotherapy treatment. The fall prevention program will consist of: 1. Otago balance exercise for 12 weeks integrated with conventional physiotherapy treatment (described in the control group). 2. Individualized advice on assistive device usage based on the participant's Berg Balance Score (BBS) revised at the 3 data collection timepoints. 3. Environmental hazard checklist. 4. Advice on getting their eyes checked and the use of appropriate footwear to ensure the elimination of other risk factors. 5. Home program (consists of balance and strength training exercises). The treatment will be delivered by four allocated physiotherapists. The physiotherapists will receive an introductory/training session on the fall prevention program prior to the commencement of the trial.

Other: fall prevention programe

Interventions

fall prevention programe OTHER

Patients in the experimental group will receive a comprehensive fall prevention program (guided by the post-TKR protocol followed at Al-Razi Orthopedic Hospital) into the conventional physiotherapy treatment

intervention (treatment) group

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: female gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female gender.
• Aged 60 years and older.
• Diagnosed with primary osteoarthritis of the knee.
• Underwent unilateral TKR.

You may not qualify if:

• revision TKR surgery
• history of systemic inflammatory conditions (i.e., rheumatoid arthritis, Lupus erythematosus),
• neurological disorders (i.e., multiple sclerosis, Parkinson's disease, stroke)
• lower limb surgery/trauma in the past 12 months
• have cognitive and/or vision impairments
• post-surgical complications (e.g., infection, intraoperative fracture)
• any health condition that may preclude them from undertaking physiotherapy.

Sponsors & Collaborators

• Ministry of Health, Kuwait: lead

Study Sites (1)

Alrazi orthopedic hospital

Kuwait City, Kuwait

RECRUITING

Related Publications (1)

• Al-Saleh H, Merza E, Al-Adwanie B, Pearson S, Malliaras P. 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. Contemp Clin Trials. 2025 Mar;150:107837. doi: 10.1016/j.cct.2025.107837. Epub 2025 Feb 6.

  PMID: 39921156 DERIVED

Study Officials

• Hadeel H Alsaleh, PhD

  Ministry of Health

  STUDY DIRECTOR

Central Study Contacts

Hadeel H Alsaleh, PhD

CONTACT

0096565064141; golden_land85@hotmail.com

Eman Y Merza, PhD

CONTACT

00965518881; dr.eman.merza8@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: neither the participant nor the outcome assessor are aware of the groups allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapy specialist

Model Details: parallel group prospective (24 weeks) randomised single-blinded pragmatic controlled trial.

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 8, 2022
• Study Start: January 8, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 8, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)