Effects of Individualized Physical Therapy and Group Physical Therapy on Functional Outcomes in Patients With Femoral Neck Fracture in Gaza Strip

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-65
SponsorAl-Azhar University - Gaza

About this trial

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

1. To examine the effect of tailored exercise intervention in reducing pain among patients who have undergone lumbar discectomy. 2. To investigate the effect of a tailored exercise intervention program in reducing the level of disability among patients who have undergone lumbar discectomy. 3. 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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients Male and female aged 50 years or older.

Diagnosed with unilateral femoral neck fracture and underwent surgical treatment.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • physical therapy and exercise

    Other intervention

    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 therapy

    Behavioral

    group physical therapy vs individualized physical therapy

  • Group Physical therapy

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Individualized Physical Therapy ProgramExperimental treatment 3 interventions
Group B: group physical therapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
6 weeks
2

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

Time frame
6 weeks
3

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.

Time frame
6 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: