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

NCT07168070 | Not Yet Recruiting

• 2 other identifiers: 20220033232855
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 1.To examine the effect of tailored exercise intervention in reducing pain among patients who have undergone lumbar discectomy.
2. 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. 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.

Conditions

Orthopaedic Disorders; Neck of Femur Fracture

Keywords

NoF

Outcome Measures

Primary Outcomes (3)

• 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)

  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

  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.

  6 weeks

Study Arms (2)

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.

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

Other: physical therapy and exercise; Behavioral: group physical therapy vs individualized physical therapy; Other: Group Physical therapy

Interventions

physical therapy and exercise OTHER

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.

Also known as: One person-focused physical therapy session

Individualized Physical Therapy Program; group physical therapy

group physical therapy vs individualized physical therapy BEHAVIORAL

group physical therapy vs individualized physical therapy

Individualized Physical Therapy Program; group physical therapy

Group Physical therapy OTHER

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.

Also known as: Group physical therapy vs individualized physical therapy

Individualized Physical Therapy Program; group physical therapy

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients Male and female aged 50 years or older.
• Diagnosed with unilateral femoral neck fracture and underwent surgical treatment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University - Gaza: lead

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Physical Therapy Modalities; Exercise

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Mohammed Nabil Matar, master

CONTACT

+970597075397; matar772015@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical instructor and researchs coordinator

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 11, 2025
• Study Start: September 22, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 21, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available within 6 months after publication of the primary results and will remain accessible for 5 years thereafter.
• Access Criteria: Researchers who provide a methodologically sound proposal and obtain approval from a relevant ethics committee will be granted access. Requests should be directed to the principal investigator via email. The data will be shared in de-identified form only, to ensure patient confidentiality, and solely for academic and research purposes.