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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-08

Study Completion Date

2026-09-08

Brief Summary

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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.

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Detailed Description

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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

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Fall Osteo Arthritis Knee Total Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

neither the participant nor the outcome assessor are aware of the groups allocation.

Study Groups

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control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention (treatment) group

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.

Group Type EXPERIMENTAL

fall prevention programe

Intervention Type 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

Interventions

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fall prevention programe

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 Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No