the Influence of Virtual Reality Approach on Phantom Pain in Trans Tibial Amputation

NCT06262503 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-02-20

No results posted yet for this study

Summary

1. To investigate the effect of Virtual reality (VR) on phantom limb pain in trans tibial amputation.
2. To investigate the effect of Virtual reality (VR) on lower limb Function in trans tibial amputation.

A sample size of 60 will be randomly allocated to two groups(30 in each group) , by using computer-generated random number list method. Control group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) for reducing phantom pain in trans -tibial amputation and the experimental group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) and Virtual Reality for reducing phantom pain in trans -tibial amputation .

Conditions

  • Phantom Pain Following Amputation of Lower Limb

Interventions

DEVICE

Virtual Reality

Virtual Reality device is used for creating 3d avatar to engage the patient into a virtual world so he can overcome his pain

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS)

TENS stimulation plays on pain gate theory it sends stimulation to close C-fibers to relieve the pain and make the patient comfortable. The electrodes were put around the stump leg (residual limb) and the session lasts for 15 minutes, the parameters were Conventional TENS - high frequency (50-100 Hz), low intensity, short pulse width (50-200 μs). Pain relief by means of the pain gate mechanism involves activation (excitation) of the A beta (Aβ) sensory fibers, and by doing so, reduces the transmission of the noxious stimulus from the 'c' fibers, through the spinal cord and hence on to the higher centers.

DEVICE

Mirroring Therapy

Mirroring Therapy :it tricks the brain. By placing a mirror between the healthy limb and the missing limb, patients see a reflection of the healthy limb, essentially "replacing" the phantom limb with a visual representation. This visual feedback is thought to reactivate brain areas responsible for the missing limb, potentially restoring its representation and reducing the discomfort of PLP. Essentially it aims to heal the brain's image of the body, which might in turn alleviate the pain associated with the missing limb.

OTHER

Phantom Exercises

The study investigated phantom exercises (PE) for phantom limb pain (PLP) relief. Patients performed specific foot and leg movements 15 times, stopping if PLP disappeared early. Exercises were repeated daily or upon PLP recurrence. Patients imagined their phantom limb position and mimicked it with their remaining limb, performing ankle, foot, knee, and hip movements until relaxation and PLP subsided.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
75 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-02-29
Completion
2024-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06262503 on ClinicalTrials.gov