Effects of Individualized Physical Therapy and Group Physical Therapy on Functional Outcomes in Patients With Femoral Neck Fracture in Gaza Strip
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Barthel Index
研究概览
简要总结
The research explores how individualized, one-on-one physical therapy programs versus group-based therapy sessions influence recovery in terms of functional mobility, pain reduction, muscle strength, balance, and overall quality of life. Patients were recruited from healthcare facilities in the Gaza Strip and were randomly assigned to either intervention group.
1.2 Justification of the study This study provides important evidence on the role of group Physical Therapy in rehabilitation outcomes, which is a key factor in enhancing both the physical and psychological recovery of patients with femoral neck fractures. By focusing on the impact of rehabilitation environments, particularly the comparison between individualized Physical Therapy and group Physical Therapy, this research addresses a critical gap in the existing literature. While much of the current research has concentrated on the physical aspects of recovery, the influence of social engagement and environmental factors remains underexplored, despite their potential to significantly improve outcomes. The findings of this study may help to inform clinical guidelines by providing a clearer understanding of how group-based rehabilitation, which encourages social interaction, could be integrated into recovery protocols for better results. Additionally, the insights gained from this research have the potential to guide policymakers and healthcare providers in the development of more effective rehabilitation programs tailored to the specific needs of patients. By optimizing rehabilitation strategies based on the rehabilitation environment, this study aims to enhance recovery times and overall Functional independency in ADLs for patients, ultimately leading to better health outcomes and a more efficient use of healthcare resources.
1.3 Study objectives 1.3.1 General objective To evaluate the effect of a tailored exercise intervention program on patients' QoL among patients who have undergone lumbar discectomy.
1.3.2 Specific objectives
- To examine the effect of tailored exercise intervention in reducing pain among patients who have undergone lumbar discectomy.
- To investigate the effect of a tailored exercise intervention program in reducing the level of disability among patients who have undergone lumbar discectomy.
- To assess the effect of a tailored exercise intervention program in reducing the level of depression and anxiety among patients who have undergone lumbar discectomy.
1.4 Hypothesis To compare the effects of individualized Physical Therapy and group Physical Therapy on functional outcomes in patients with femoral neck fractures in Gaza strip.
1.5 Specific Objectives
To evaluate the effects of individualized Physical Therapy Program on functional independence in the ADLs, sleep quality, depression and anxiety in patients with femoral neck fractures in Gaza strip.
To evaluate the effects of group Physical Therapy Program on functional independence in the ADLs, sleep quality, depression and anxiety in patients with femoral neck fractures in Gaza Strip.
1.6. Hypothesis 1.6.1 H0 There will be no significant difference in functional independence in ADLs between patients recovering from femoral neck fractures who undergo rehabilitation in individualized Physical Therapy and group Physical Therapy.
1.6.2 H1 There will be a significant difference in functional independence in ADLs between patients recovering from femoral neck fractures who undergo rehabilitation in individualized Physical Therapy and group Physical Therapy.
There will be a significant difference in sleep quality between patients recovering from femoral neck fractures who undergo rehabilitation in individualized Physical Therapy and group Physical Therapy.
There will be a significant difference in depression and anxiety symptoms between patients recovering from femoral neck fractures who undergo rehabilitation in individualized Physical Therapy and group Physical Therapy.
1.7 Research Questions
Is there a significant difference in functional independence in ADLs between patients recovering from femoral neck fractures who undergo rehabilitation in individualized Physical Therapy and group Physical Therapy? Is there a significant difference in sleep quality between patients recovering from femoral neck fractures who undergo rehabilitation in individualized Physical Therapy and group Physical Therapy? Is there a significant difference in depression and anxiety symptoms between patients recovering from femoral neck fractures who undergo rehabilitation in individualized Physical Therapy and group Physical Therapy? What are the baseline levels of functional independence in ADLs, depression, anxiety, functional mobility, and sleep quality among patients with femoral neck fractures screened for the study?
详细描述
Femoral neck fractures are a significant public health concern, particularly among the elderly population. According to Dyer the incidence of hip fractures is rising, leading to a marked decline in physical function and increased morbidity and mortality rates . For patients experiencing hip fractures, key outcomes such as survivability, morbidity, and functional independence in activities of daily living (ADLs) are profoundly impacted. Hip fractures abruptly alter a person's life and may increase their reliance on others to carry out everyday tasks.
Femoral neck fractures have a significant negative impact on quality of life by creating mobility issues. After being hospitalized for a hip fracture, only roughly 60% of patients are able to walk normally again. A growing percentage of people who survive neck of fracture injuries go on to suffer from varying degrees of later handicap, such as the development of excruciating osteoarthritis in their hip joints, a high risk of falls, and additional hip fracture injuries. Furthermore, Fractured individuals experience lower quality of life due to poor balance and movement, as well as reduced functional and social independence. This suggests that many people never resume their pre-fracture way of life.
While much of the existing research has focused on the physical aspects of recovery, such as restoring pre-fracture functional abilities, less attention has been given to the psychological factors that influence functional mobility. Successful recovery is not solely dependent on physical rehabilitation but also on psychological well-being. Psychological comorbidities are significantly associated with both mortality and functional outcome in patients with neck of femur fractures. More than half of all patients reported continued sleep disturbance 3 months post orthopaedic operation. Early identification and management of sleep disturbances can improve functional and emotional recovery outcomes. Fatigue from poor sleep may hinder adherence to home exercise regimens, impacting overall recovery .
Also, patients with a femoral neck fracture are at an increased risk of subsequent major depression. Interestingly, patients undergoing surgery for femoral neck fracture with comorbid psychological problems are at increased risk for non-routine discharge. These problems are independently associated with an increased risk for post-operative complications. An awareness of these risks should optimize preoperative multidisciplinary patient care planning so as to maximize patient outcome.
In patients with a hip fracture, post-operative rehabilitation can enhance clinical results and quality of life. Prolonged immobilization can lead to functional decline and complications like falls and pressure ulcers. Early mobilization helps prevent these issues. A systematic review conducted by Peeters, et al found that home-based rehabilitation programs incorporating strength exercises significantly improved health status components. Additionally, stone et al. found that a more intensive community-based multimodal therapy (six or more in-person sessions per week) did not lead to better outcomes at three months compared to a less frequent regimen (three or fewer sessions per week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients Male and female aged 50 years or older.
- •Diagnosed with unilateral femoral neck fracture and underwent surgical treatment.
排除标准
- •Patients with bilateral fractures or multiple trauma injuries.
- •Patients with pathological related fractures.
- •Presence of severe cognitive impairment (e.g., advanced dementia).
- •Severe neurological disorders (e.g., stroke, Parkinson's disease) that affect mobility.
- •Unstable cardiovascular conditions that limit exercise participation.
- •Not willing to provide informed consent.
- •Unable to participate in Physical Therapy with or without assistance
结局指标
主要结局
Barthel Index
时间窗: 6 weeks
a tool used to evaluate the functional independence in ADLs (toileting, bathing, eating, dressing, continence, transfers, and ambulation). Each task received a numerical score based on whether the patient required physical assistance to perform it. A patient scoring 0 points would be dependent in all assessed ADLs, whereas a score of 100 would reflect independence in all activities. Barthel Index is a valid and reliable tool to measure the functional independence. It has adequate reliability (intraclass correlation coefficient ≥ 0.962) and internal consistency (Cronbach's alpha = 0.942)
Hospital Anxiety and Depression Scale (HADS)
时间窗: 6 weeks
Hospital Anxiety and Depression Scale (HADS) is a self-assessment tool used to screen for anxiety and depression in patients, especially in non-psychiatric medical settings. It consists of 14 items: 7 for anxiety (HADS-A) and 7 for depression (HADS-D), each scored on a 4-point scale (0-3). Scores range from 0-21 for each subscale, with higher scores indicating more severe symptoms
Subjective sleep quality
时间窗: 6 weeks
Sleep quality will be assessed by Pittsburgh Sleep Quality Index (PSQI). PSQI consists of 19-items that assess seven dimensions: duration of sleep, subjective sleep quality, sleep latency, sleep disturbance, habitual sleep efficiency, taking sleep medications, and daytime dysfunction over the last month. Cronbach's α for the seven component scores that comprise the PSQI global score was 0.74, which suggests good internal consistency.
次要结局
未报告次要终点
研究者
Mohammed Nabil Matar
clinical instructor and researchs coordinator
Al-Azhar University - Gaza