Virtual Reality-based Exercises on Postural Stability, Depressive Symptoms and Anxiety in Patients with Lower Extremity Burn

NCT ID: NCT06776887

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2025-05-15

Brief Summary

A burn can be a life-threatening and traumatic event associated with severe pain and long-term health problems. Psychological difficulties are often reported after a burn, and symptoms of depression are one of the most common [1,2]. Physiological and state anxiety increased as a result of increased postural threat whereas ratings of perceived stability and balance efficacy were reduced as a function of increased postural threat. Efforts to diagnose balance disorders based on balance performance may be confounded by the influence of psychological factors. In a systematic review of the prevalence of depression after a burn, 4%-10% met the criteria for major depression within a year after the burn, and the rate of clinically relevant depressive symptoms measured by self-reporting was 4%-26% [3]. In addition, depressive symptoms after a burn have been associated with deterioration in long-term physical functioning and health-related quality of life (HRQoL) [[4], [5], [6]].

For patients with burns, studies have reported symptoms of anxiety in hospital [7,8], but Williams and Griffiths [9] reported that one third of a sample of 23 survivors of burns were still having appreciable psychological difficulties one year after the burn. Anxiety was the most common, followed by post-traumatic stress syndrome and depression Many treatments are available to treat anxiety and depression disorders, including medication, exercise, meditation, and cognitive behavioral therapy. In many cases, these treatments can be tailored to a client to help reduce symptomology of anxiety and/or depression. To date, the application of emerging technology in health promotion has generated substantial public interest. Among the emerging technologies that may potentially aid in the treatment of anxiety and depression, virtual reality (VR) is arguably the most exciting and technologically-advanced. VR is a digital technology that artificially creates sensory experiences-including visual, auditory, touch, and scent stimuli-while allowing the user to manipulate objects within the virtual environment created [3].

Detailed Description

A burn can be a life-threatening and traumatic event associated with severe pain and long-term health problems. Psychological difficulties are often reported after a burn, and symptoms of depression are one of the most common [1,2]. Physiological and state anxiety increased as a result of increased postural threat whereas ratings of perceived stability and balance efficacy were reduced as a function of increased postural threat. Efforts to diagnose balance disorders based on balance performance may be confounded by the influence of psychological factors. In a systematic review of the prevalence of depression after a burn, 4%-10% met the criteria for major depression within a year after the burn, and the rate of clinically relevant depressive symptoms measured by self-reporting was 4%-26% [3]. In addition, depressive symptoms after a burn have been associated with deterioration in long-term physical functioning and health-related quality of life (HRQoL) [[4], [5], [6]].

For patients with burns, studies have reported symptoms of anxiety in hospital [7,8], but Williams and Griffiths [9] reported that one third of a sample of 23 survivors of burns were still having appreciable psychological difficulties one year after the burn. Anxiety was the most common, followed by post-traumatic stress syndrome and depression Many treatments are available to treat anxiety and depression disorders, including medication, exercise, meditation, and cognitive behavioral therapy. In many cases, these treatments can be tailored to a client to help reduce symptomology of anxiety and/or depression. To date, the application of emerging technology in health promotion has generated substantial public interest. Among the emerging technologies that may potentially aid in the treatment of anxiety and depression, virtual reality (VR) is arguably the most exciting and technologically-advanced. VR is a digital technology that artificially creates sensory experiences-including visual, auditory, touch, and scent stimuli-while allowing the user to manipulate objects within the virtual environment created [3].

to our knowledge there is lack of studies assessing the effect of virtual reality based exercises on balance, depressive symptoms and anxiety in adult patients with lower extremity burn so this study is designed to assess the effect of virtual reality based exercises on balance, depressive symptoms and anxiety in adult patients with lower extremity burn

Conditions

Patients with Lower Extremity Burn; Postural Stability, Depressive Symptoms and Anxiety in Patients with Lower Extremity Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group A(Wii fit group)

The Wii Fit group will receive the Wii Fit program for 30 minutes in addition to SPTP for 60 minutes, whereas. The intervention was 3 sessions a week for 12 weeks.

Group Type: EXPERIMENTAL

The Wii Fit group will receive the Wii Fit program for 30 minutes in addition to SPTP for 60 minutes, whereas. The intervention was 3 sessions a week for 12 weeks

Intervention Type: DEVICE

The Wii Fit group will receive the Wii Fit program for 30 minutes in addition to SPTP for 60 minutes, whereas. The intervention was 3 sessions a week for 12 weeks.

The control group will receive standard physical therapy program (SPTP) only 3 sessions a week for 12 weeks .

group B(control group)

The control group will receive standard physical therapy program (SPTP) only 3 sessions a week for 12 weeks .

Group Type: ACTIVE_COMPARATOR

The Wii Fit group will receive the Wii Fit program for 30 minutes in addition to SPTP for 60 minutes, whereas. The intervention was 3 sessions a week for 12 weeks

Intervention Type: DEVICE

The Wii Fit group will receive the Wii Fit program for 30 minutes in addition to SPTP for 60 minutes, whereas. The intervention was 3 sessions a week for 12 weeks.

The control group will receive standard physical therapy program (SPTP) only 3 sessions a week for 12 weeks .

Interventions

The Wii Fit group will receive the Wii Fit program for 30 minutes in addition to SPTP for 60 minutes, whereas. The intervention was 3 sessions a week for 12 weeks

The Wii Fit group will receive the Wii Fit program for 30 minutes in addition to SPTP for 60 minutes, whereas. The intervention was 3 sessions a week for 12 weeks.

The control group will receive standard physical therapy program (SPTP) only 3 sessions a week for 12 weeks .

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age of the patient will be ranged from 35 to 55 years; 2) weight range 60-85 kg, height 155-170 cm; 3) total burned surface area (TBSA) was more than 40% measured by the rule of nines; 4) the burn cause was thermal; 5) burn depth, partial-thickness burn injury; 6) at least 3 months after burn injuries; 7) and with low physical activity level.

Exclusion Criteria

• Patients will be excluded if they had 1) inhalation injury; 2) leg amputation; 3) any limitation in LL range of motion; 4) auditory or visual problems; 5) congenital musculoskeletal deformities, especially in the foot; 6) psychiatric disorders; 7) paralysis; or 8) cardiac abnormalities or cardiac pacemakers.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Zeinab Abd el fattah Ali

Assistant Professor of physical therapy for surgery, Faculty of physical therapy-cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Zeinab Abd El Fattah Ali Zeinab Abd El Fattah Ali, Assistant professor

Role: CONTACT

zeinaboh4@gmail.com

+201061360551

Nesma Morgan Allam Nesma Morgan Allam, assistant professor

Role: CONTACT

Dr.nesma2011@yahoo.com

+201281968332

Facility Contacts

7 Ahmed Alzayate Street, Been U´ lsarayat, Giza, Egypt. assistant professor

Role: primary

zeinaboh4@gmail.com

+2237617691

Other Identifiers

P.T.REC/012/005525

Identifier Type: -

Identifier Source: org_study_id