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Recruiting NCT06776887

NCT06776887 Virtual Reality-based Exercises on Postural Stability, Depressive Symptoms and Anxiety in Patients with Lower Extremity Burn

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Clinical Trial Summary
NCT ID NCT06776887
Status Recruiting
Phase
Sponsor Cairo University
Condition Patients with Lower Extremity Burn
Study Type INTERVENTIONAL
Enrollment 40 participants
Start Date 2025-01-10
Primary Completion 2025-05-10

Eligibility & Interventions

Sex All sexes
Min Age 35 Years
Max Age 55 Years
Study Type INTERVENTIONAL
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

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 40 participants in total. It began in 2025-01-10 with a primary completion date of 2025-05-10.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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 \[3\].

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.

Contact & Investigator

Central Contact

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

✉ zeinaboh4@gmail.com

📞 +201061360551

Frequently Asked Questions

Who can join the NCT06776887 clinical trial?

This trial is open to participants of all sexes, aged 35 Years or older, up to 55 Years, studying Patients with Lower Extremity Burn. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06776887 currently recruiting?

Yes, NCT06776887 is actively recruiting participants. Contact the research team at zeinaboh4@gmail.com for enrollment information.

Where is the NCT06776887 trial being conducted?

This trial is being conducted at Giza, Egypt.

Who is sponsoring the NCT06776887 clinical trial?

NCT06776887 is sponsored by Cairo University. The trial plans to enroll 40 participants.

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