FallNCT05642260
Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement
A study testing fall prevention programe in people with Fall and Osteo Arthritis Knee, run by Ministry of Health, Kuwait at 1 site in Kuwait.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Fall, Osteo Arthritis Knee, Total Knee Replacement
- What is being tested?
- fall prevention programe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteKuwait
- Study dates
- 8 Jan 2023to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female gender.
- Aged 60 years and older.
- Diagnosed with primary osteoarthritis of the knee.
- Underwent unilateral TKR.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kuwait1 site, 1 recruiting
- Recruiting
Alrazi orthopedic hospital
Kuwait City
Hadeel Alsaleh, PhD, 0096565064141
Eman Merza, PhD
About this study
Official title: 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.
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.
Read the detailed description
Falls constitute a serious and common threat to the health and well-being of older individuals, and this threat increases with aging. Falls in older individuals place a significant burden on the health care system as well as the caregivers (i.e., family). Importantly, however, many falls could be prevented.
Osteoarthritis (OA) of the knee is a common degenerative musculoskeletal condition among elderly that results in ambulatory dysfunction. This progressive degenerative disorder is usually associated with pain, muscle weakness, and poor balance, all of which are considered primary risk factors for falling among older adults. Total knee replacement (TKR) is the most replicable and effective orthopaedic procedure used to treat advanced-stage knee OA. The goal of TKR is to relieve pain, increase knee mobility, and improve functional ability and the overall quality of life. Despite the promising results of TKR surgery, it is associated with a high prevalence of falls. In this regard, falls rate have been reported to be between 6.2% and 42.6% in the first 12 months following TKR. Persistence of muscle weakness and poor balance may contribute to the high fall rate following TKR. This highlights the importance of targeting muscle strength and balance during rehabilitation, considering the short-term implications that could reflect on long-term recovery.
A substantial amount of evidence supports the use of exercise-based interventions (i.e., muscle strengthening and balance training) to prevent falls and fall-related injuries. A Cochrane systematic review by on 108 RCTs (n=23,407) provided high-certainty evidence that exercises, particularly balance and functional based-exercises, are more effective in reducing the falls rate compared to the control interventions. Moreover, exercise-based interventions have been shown to be superior to other interventions for mitigating age-related decline and reducing falls and falls-related injuries with the least harm and greatest cost-effectiveness.
Conventional physiotherapy following TKR involves, primarily, strengthening and knee range of motion exercises and gait re-education. However, there is a lack of balance training/exercises in the rehabilitation program. Given the high prevalence of falls following TKR, integrating a comprehensive fall prevention program into conventional physiotherapy may be of importance. Thus, 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.
- Conditions
- Fall, Osteo Arthritis Knee, Total Knee Replacement
- Being tested
- fall prevention programe
- Keywords
- fall, older people, fall prevention, TKR, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fall prevention programeOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: fall prevention programe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 1 year
Secondary outcomes (6)
Knee range of motion (ROM)
This will be measured using goniometer while the patient is laying in supine position with the operated knee fully extended. The patient will be requested to bend her knee 2-3 times before the actual measurements are taken. Then, the investigator will take three consecutive measurements of knee flexion range.
Measured: baseline
Knee range of motion (ROM)
This will be measured using goniometer while the patient is laying in supine position with the operated knee fully extended. The patient will be requested to bend her knee 2-3 times before the actual measurements are taken. Then, the investigator will take three consecutive measurements of knee flexion range.
Measured: 12 weeks
Patient's satisfaction
In response to the question 'how satisfied are you with the results of physiotherapy treatment?'. Patients will be asked to grade their level of satisfaction on a 5-point Likert scale (1: not at all satisfied, 2: dissatisfied, 3: neutral, 4: satisfied, or 5: very satisfied).
Measured: 12 weeks
Patient's satisfaction
In response to the question 'how satisfied are you with the results of physiotherapy treatment?'. Patients will be asked to grade their level of satisfaction on a 5-point Likert scale (1: not at all satisfied, 2: dissatisfied, 3: neutral, 4: satisfied, or 5: very satisfied).
Measured: 1 year
Adherence:
- Adherence to the prescribed home-program: Patient's adherence to the prescribed exercise/home program will be measured by a retrospective patient self-report scale, a simple method that has been implemented by other researchers to measure patient's adherence to the prescribed exercise. (Mallows et al., 2020, Bassett, 2003) In response to the question "If you have been requested by your physiotherapist to do exercises at home, please indicates the extent you have followed the instructions?", participants responded using a 5-point Likert scale ranging from 1 (not at all) to 5 (as advised).
- Adherence to physiotherapy attendance: The total number of treatment sessions received by the patient will be recorded by the treating physiotherapist.
Measured: 12 weeks
Adherence:
- Adherence to the prescribed home-program: Patient's adherence to the prescribed exercise/home program will be measured by a retrospective patient self-report scale, a simple method that has been implemented by other researchers to measure patient's adherence to the prescribed exercise. (Mallows et al., 2020, Bassett, 2003) In response to the question "If you have been requested by your physiotherapist to do exercises at home, please indicates the extent you have followed the instructions?", participants responded using a 5-point Likert scale ranging from 1 (not at all) to 5 (as advised).
- Adherence to physiotherapy attendance: The total number of treatment sessions received by the patient will be recorded by the treating physiotherapist.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start8 Jan 2023
- Primary completionApr 2026 (estimated)
- Study completion8 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel group prospective (24 weeks) randomised single-blinded pragmatic controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Kuwait
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Hadeel Alsaleh, Ministry of Health, Kuwait
- Investigators
- Hadeel H Alsaleh, PhD, Study director, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642260
- Sponsor's protocol ID
- 2146/2022
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39921156
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05642260
- Acronym / sponsor ID
- 2146/2022
- Conditions
- Fall, Osteo Arthritis Knee, Total Knee Replacement
- Keywords
- fall, older people, fall prevention, TKR, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ministry of Health, KuwaitOther government
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- 8 Sep 2026 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Falls constitute a serious and common threat to the health and well-being of older individuals, and this threat increases with aging. Falls in older individuals place a significant burden on the health care system as well as the caregivers (i.e., family). Importantly, however, many falls could be prevented.
Osteoarthritis (OA) of the knee is a common degenerative musculoskeletal condition among elderly that results in ambulatory dysfunction. This progressive degenerative disorder is usually associated with pain, muscle weakness, and poor balance, all of which are considered primary risk factors for falling among older adults. Total knee replacement (TKR) is the most replicable and effective orthopaedic procedure used to treat advanced-stage knee OA. The goal of TKR is to relieve pain, increase knee mobility, and improve functional ability and the overall quality of life. Despite the promising results of TKR surgery, it is associated with a high prevalence of falls. In this regard, falls rate have been reported to be between 6.2% and 42.6% in the first 12 months following TKR. Persistence of muscle weakness and poor balance may contribute to the high fall rate following TKR. This highlights the importance of targeting muscle strength and balance during rehabilitation, considering the short-term implications that could reflect on long-term recovery.
A substantial amount of evidence supports the use of exercise-based interventions (i.e., muscle strengthening and balance training) to prevent falls and fall-related injuries. A Cochrane systematic review by on 108 RCTs (n=23,407) provided high-certainty evidence that exercises, particularly balance and functional based-exercises, are more effective in reducing the falls rate compared to the control interventions. Moreover, exercise-based interventions have been shown to be superior to other interventions for mitigating age-related decline and reducing falls and falls-related injuries with the least harm and greatest cost-effectiveness.
Conventional physiotherapy following TKR involves, primarily, strengthening and knee range of motion exercises and gait re-education. However, there is a lack of balance training/exercises in the rehabilitation program. Given the high prevalence of falls following TKR, integrating a comprehensive fall prevention program into conventional physiotherapy may be of importance. Thus, 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel group prospective (24 weeks) randomised single-blinded pragmatic controlled trial.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: fall prevention programePatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female gender.
- Aged 60 years and older.
- Diagnosed with primary osteoarthritis of the knee.
- Underwent unilateral TKR.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fall prevention programePatients 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 | Other | intervention (treatment) group |
Primary outcome
falls rate
Time frame: baseline
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).
falls rate
Time frame: 12 weeks
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).
falls rate
Time frame: 1 year
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).
6 secondary outcomes
Knee range of motion (ROM)
Time frame: baseline
Knee range of motion (ROM)
Time frame: 12 weeks
Patient's satisfaction
Time frame: 12 weeks
Patient's satisfaction
Time frame: 1 year
Adherence:
Time frame: 12 weeks
Adherence:
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Derived from this study: PubMed 39921156Al-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hadeel H Alsaleh, PhD study director
Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fall prevention programe in people with Fall and Osteo Arthritis Knee, run by Ministry of Health, Kuwait at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hadeel H Alsaleh, PhD (0096565064141, golden_land85@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
falls rate (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05642260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.