Orthopaedic Disordersneck of femureNCT07168070
Effects of Individualized Physical Therapy and Group Physical Therapy on Functional Outcomes in Patients With Femoral Neck Fracture in Gaza Strip
A study testing physical therapy and exercise, group physical therapy vs individualized physical therapy and Group Physical therapy in people with Orthopaedic Disorders and Neck of Femur Fracture, run by Al-Azhar University - Gaza.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Orthopaedic Disorders, Neck of Femur Fracture
- What is being tested?
- physical therapy and exercise, group physical therapy vs individualized physical therapy and Group Physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2025to 21 Oct 2025
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients Male and female aged 50 years or older.
- Diagnosed with unilateral femoral neck fracture and underwent surgical treatment.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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?
Read the detailed description
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).
Group-based rehabilitation strategies have also been shown to enhance functional outcomes. Coulter found that group Physical Therapy following joint replacement surgery yielded functional recovery results comparable to customized home-based physical therapy. Similarly, Tarakci demonstrated that supervised group exercise training significantly improved balance and functional status in patients with multiple sclerosis, further reinforcing the effectiveness of group-based interventions. On the other hand, O'Keeffe compared the efficacy of individual and group Physical Therapy exercise programs for musculoskeletal problems. Their findings revealed no clinically significant differences between the two approaches in terms of pain and impairment outcome. Previous research suggests that group engagement during rehabilitation can enhance motivation and improve recovery outcomes. In contrast, individualized rehabilitation may provide more focused care but could lack the psychological and social benefits associated with group-based therapy. So, it is not clear whether exercises performed in a group or individualized settings are better for improving outcomes post femoral neck fractures.
There is a gap in the literature regarding the impact of rehabilitation environments (group and individualized setting) on functional mobility and ADL independence in patients recovering from femoral neck fractures. To our knowledge, a few studies have examined the influence of Physical Therapy interventions on functional and psychological factors in this population. Thus, this study aims to bridge this gap by exploring the effect of different rehabilitation settings on functional mobility, ADL independence, sleep and psychological factors in patients recovering from femoral neck fractures.
Statement of The Problem
Despite the profound effects of femoral neck fractures on both physical and mental health, there is a notable lack of comprehensive rehabilitation protocols tailored to address the multifaceted needs of these patients. Current rehabilitation practices often focus primarily on physical recovery, neglecting the critical psychological and sleep-related aspects that are essential for holistic recovery. Femoral neck fractures often lead to a decline in physical function, resulting in increased dependence on caregivers and a reduced ability to perform activities of daily living (ADLs). Furthermore, the aftermath of femoral neck fractures is frequently accompanied by sleep disturbances, which can exacerbate fatigue and hinder recovery. The psychological ramifications are equally concerning, as many patients experience heightened levels of depression and anxiety following their injury, further complicating their rehabilitation process Study objectives
General objective:
To compare the effects of individualized Physical Therapy and group Physical Therapy on functional outcomes in patients with femoral neck fractures in Gaza strip.
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.
Hypothesis 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.
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? 1.5 Theoretical and Operational Definition of Terms Femoral neck fractures occur in the femoral neck, which is where the femoral head and shaft meet. Because of its placement, the femoral neck is prone to fracture, and in cases where it is displaced, disruption of the femoral head's blood supply is a major issue.
Group physical therapy is a rehabilitation technique in which a professional physical therapist supervises therapeutic exercises or activities for two or more patients at the same time with the purpose of safely and effectively addressing individual or shared goals Individualized Physical Therapy is a rehabilitation technique in which a professional physical therapist supervises therapeutic exercises or activities for only one patient
- Conditions
- Orthopaedic Disorders, Neck of Femur Fracture
- Being tested
- physical therapy and exercise, group physical therapy vs individualized physical therapy, Group Physical therapy
- Keywords
- NoF
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy and exerciseOther
Also called One person-focused physical therapy session
Participants will receive one-on-one physiotherapy sessions, 45 minutes each, three times per week for 6 weeks. Sessions will include range of motion, strengthening, balance, and gait training.
Home-based Exercise Participants will be instructed to perform a structured home exercise program to complement in-clinic sessions.
group physical therapy vs individualized physical therapyBehavioural
group physical therapy vs individualized physical therapy
Group Physical therapyOther
Also called Group physical therapy vs individualized physical therapy
Participants will attend group physiotherapy sessions, where several patients receive treatment at the same time. Each session lasts 45 minutes, three times per week for 6 weeks, and includes range of motion, strengthening, balance, and gait training.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Physical Therapy Program | Experimental | Participants will receive one-on-one physiotherapy sessions, 45 minutes each, three times per week for 8 weeks, including range of motion, strengthening, balance, and gait training. Receives: Other: physical therapy and exercise; Behavioral: group physical therapy vs individualized physical therapy; Other: Group Physical therapy |
| group physical therapy | Experimental | group of people given the same treatment at the time Receives: Other: physical therapy and exercise; Behavioral: group physical therapy vs individualized physical therapy; Other: Group Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index
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)
Measured: 6 weeks
Hospital Anxiety and Depression Scale (HADS)
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
Measured: 6 weeks
Subjective sleep quality
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start22 Sep 2025 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completion21 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University - Gaza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Nabil Matar, Al-Azhar University - Gaza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168070
- Sponsor's protocol ID
- 20220033
- Other IDs
- 232855
- Acronym
- neck of femure
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified individual participant data (IPD) underlying the results of this study will be made available to other researchers upon reasonable request. Data to be shared include demographic information, baseline characteristics, and outcome measures related to functional recovery, mobility, and quality of life following femoral neck fracture.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized Physical Therapy and Group Physical Therapy on Functional Outcomes in Patients With Femoral Neck Fracture in Gaza Strip
- ClinicalTrials.gov ID
- NCT07168070
- Acronym / sponsor ID
- neck of femure / 20220033
- Conditions
- Orthopaedic Disorders, Neck of Femur Fracture
- Keywords
- NoF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Al-Azhar University - GazaUniversity, hospital or other
- Study start
- 22 Sep 2025 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 21 Oct 2025 (estimated)
- First posted
- 11 Sep 2025 (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 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?
Detailed description
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).
Group-based rehabilitation strategies have also been shown to enhance functional outcomes. Coulter found that group Physical Therapy following joint replacement surgery yielded functional recovery results comparable to customized home-based physical therapy. Similarly, Tarakci demonstrated that supervised group exercise training significantly improved balance and functional status in patients with multiple sclerosis, further reinforcing the effectiveness of group-based interventions. On the other hand, O'Keeffe compared the efficacy of individual and group Physical Therapy exercise programs for musculoskeletal problems. Their findings revealed no clinically significant differences between the two approaches in terms of pain and impairment outcome. Previous research suggests that group engagement during rehabilitation can enhance motivation and improve recovery outcomes. In contrast, individualized rehabilitation may provide more focused care but could lack the psychological and social benefits associated with group-based therapy. So, it is not clear whether exercises performed in a group or individualized settings are better for improving outcomes post femoral neck fractures.
There is a gap in the literature regarding the impact of rehabilitation environments (group and individualized setting) on functional mobility and ADL independence in patients recovering from femoral neck fractures. To our knowledge, a few studies have examined the influence of Physical Therapy interventions on functional and psychological factors in this population. Thus, this study aims to bridge this gap by exploring the effect of different rehabilitation settings on functional mobility, ADL independence, sleep and psychological factors in patients recovering from femoral neck fractures.
Statement of The Problem
Despite the profound effects of femoral neck fractures on both physical and mental health, there is a notable lack of comprehensive rehabilitation protocols tailored to address the multifaceted needs of these patients. Current rehabilitation practices often focus primarily on physical recovery, neglecting the critical psychological and sleep-related aspects that are essential for holistic recovery. Femoral neck fractures often lead to a decline in physical function, resulting in increased dependence on caregivers and a reduced ability to perform activities of daily living (ADLs). Furthermore, the aftermath of femoral neck fractures is frequently accompanied by sleep disturbances, which can exacerbate fatigue and hinder recovery. The psychological ramifications are equally concerning, as many patients experience heightened levels of depression and anxiety following their injury, further complicating their rehabilitation process Study objectives
General objective:
To compare the effects of individualized Physical Therapy and group Physical Therapy on functional outcomes in patients with femoral neck fractures in Gaza strip.
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.
Hypothesis 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.
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? 1.5 Theoretical and Operational Definition of Terms Femoral neck fractures occur in the femoral neck, which is where the femoral head and shaft meet. Because of its placement, the femoral neck is prone to fracture, and in cases where it is displaced, disruption of the femoral head's blood supply is a major issue.
Group physical therapy is a rehabilitation technique in which a professional physical therapist supervises therapeutic exercises or activities for two or more patients at the same time with the purpose of safely and effectively addressing individual or shared goals Individualized Physical Therapy is a rehabilitation technique in which a professional physical therapist supervises therapeutic exercises or activities for only one patient
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Physical Therapy Program | Experimental | Other: physical therapy and exercise, Behavioral: group physical therapy vs individualized physical therapy, Other: Group Physical therapyParticipants will receive one-on-one physiotherapy sessions, 45 minutes each, three times per week for 8 weeks, including range of motion, strengthening, balance, and gait training. |
| group physical therapy | Experimental | Other: physical therapy and exercise, Behavioral: group physical therapy vs individualized physical therapy, Other: Group Physical therapygroup of people given the same treatment at the time |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients Male and female aged 50 years or older.
- Diagnosed with unilateral femoral neck fracture and underwent surgical treatment.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| physical therapy and exerciseAlso: One person-focused physical therapy sessionParticipants will receive one-on-one physiotherapy sessions, 45 minutes each, three times per week for 6 weeks. Sessions will include range of motion, strengthening, balance, and gait training. Home-based Exercise Participants will be instructed to perform a structured home exercise program to complement in-clinic sessions. | Other | Individualized Physical Therapy Program, group physical therapy |
| group physical therapy vs individualized physical therapygroup physical therapy vs individualized physical therapy | Behavioural | Individualized Physical Therapy Program, group physical therapy |
| Group Physical therapyAlso: Group physical therapy vs individualized physical therapyParticipants will attend group physiotherapy sessions, where several patients receive treatment at the same time. Each session lasts 45 minutes, three times per week for 6 weeks, and includes range of motion, strengthening, balance, and gait training. | Other | Individualized Physical Therapy Program, group physical therapy |
Primary outcome
Barthel Index
Time frame: 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)
Time frame: 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
Time frame: 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.
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 11 Sep 2025.
- Individual participant dataSharing planned: Yes. The de-identified individual participant data (IPD) underlying the results of this study will be made available to other researchers upon reasonable request. Data to be shared include demographic information, baseline characteristics, and outcome measures related to functional recovery, mobility, and quality of life following femoral neck fracture.
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Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Recruiting
Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
Perioperative Care, Intermittent Fasting
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.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy and exercise, group physical therapy vs individualized physical therapy and Group Physical therapy in people with Orthopaedic Disorders and Neck of Femur Fracture, run by Al-Azhar University - Gaza.
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 2 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: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Mohammed Nabil Matar, master (+970597075397, matar772015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel Index (time frame: 6 weeks). 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?
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 11 Sep 2025.