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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60+
SponsorMinistry of Health, Kuwait

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female gender.

Aged 60 years and older.

Diagnosed with primary osteoarthritis of the knee.

Underwent unilateral TKR.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • fall prevention programe

    Other intervention

    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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: control groupNo intervention 0 interventions
Group B: intervention (treatment) groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
baseline
2

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).

Time frame
12 weeks
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).

Time frame
1 year

Secondary outcomes

1

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.

Time frame
baseline
2

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.

Time frame
12 weeks
3

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).

Time frame
12 weeks
4

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).

Time frame
1 year

Other outcomes

1

Numerical Pain Rating Scale NPRS

The worst pain experienced in the last week will be measured using the Numerical Pain Rating Scale (NPRS). The NPRS requires the patients to rate their pain on a defined scale from 0-10 where 0 indicates no pain and 10 indicates the worst pain imaginable. Patients will be asked "Regarding your knee pain, how would you rate the worst pain that you have experienced during the last week?". A numeric change of two points on NPRS often represents a clinically important difference.

Time frame
baseline, 12 weeks, 1 year
2

10-meter walk test

This test assesses walking speed in meters per second over a short distance. The subject walks without assistance for 10 meters (32.8 feet) and the time is measured for the intermediate 6 meters (19.7 feet) to allow for acceleration and deceleration.

Time frame
baseline, 12 weeks
3

Timed Up and Go test

This test measures, in seconds, the time taken by an individual to stand up from a standard armchair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. The time taken to complete the task is strongly correlated to level of functional mobility, (i.e. the more time taken, the more dependent in activities of daily living).

Time frame
baseline, 12 weeks
4

Berg Balance Scale (BBS)

Is a 14-item scale designed to measure balance of the older adult in a clinical setting. Each item consists of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. The total score equals 56. Score of \< 45 indicates individuals may be at greater risk of falling (Berg et al., 1992).

Time frame
baseline, 12 weeks

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