The Impact of Innovative Technology Strategies on Implementing Exercise Programs Using Fully Immersive Virtual Reality for Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Effect on lumbopelvic pain
研究概览
简要总结
The study aims to determine the effect of traditional exercise through using fully immersive virtual reality in postpartum female with lumbopelvic pain.
This study will be single-blind randomized clinical -trial and will be conducted at Shalamar Institute of health sciences in 1 year after the approval by institutional review board. Sixty female participants with a history of lumbopelvic pain will be recruited on the basis of inclusion and exclusion criteria. Data will be collected after taking written Informed Consent from each patient. The included participants will be randomized by gold fish randomization method and allocated to two groups (A & B) each with 30 participants.
详细描述
Lumbopelvic pain refers to self-reported pain in the lower back, sacroiliac joints, or a combination of these locations, among pregnant and postnatal women. Approximately 50% of pregnant women report lumbopelvic pain to some degree. Recent studies indicate the importance of hip extensors, pelvic floor muscle (PFM) and transverse abdominal muscle (TrAM) in the development of lumbopelvic pain.Moreover, pelvic instability, asymmetry and insufficient compression of the sacroiliac joints contribute to continuous lumbopelvic pain after delivery. In Europe every tenth women shortly postpartum and every sixth has reported similar symptoms 6 weeks later. Age, PGP during pregnancy and abdominal midline doming were associated with experiencing PGP shortly postpartum.
Studies have demonstrated the importance of choosing an optimal treatment strategy in clinical practice, and 5 subgroups of self-rated pain locations have been identified in the pelvic area. The study focused on pelvic girdle pain (PGP), or PGP in combination with lumbar pain, since these groups have been shown to have the highest impact on activity levels and health-related quality of life.
Traditional exercises that include dynamically controlling the lumbar segments and pelvic joints have been shown to result in functional improvement in patients with lumbopelvic pain. The term "core stability" is commonly used to refer to the ability of these "core" muscles to stabilize the lumbar spine and pelvic girdle during static postures and dynamic movements. A host of theories and "stabilization exercise" programs have been developed to train these muscles as a means of treating and/or preventing lower back pain (LBP). However, there is still much inconsistency and debate both in the clinical and research communities with regards to what constitutes "core stability" and a "stabilization exercise". Chronic pain is a global healthcare burden with as much as of 11% of the US population suffering from pain lasting six months or longer, and upwards of 20% in Europe. Chronic pain can lead to depression, anxiety, sleep disturbances, and impairment in cognitive tasks.
Established research supports VR(virtual relaity) as a treatment strategy for burn pain, acute pain, and experimentally induced pain. Two primary approaches afford analgesic benefits of VR: distraction therapy and immersive-ness. Distraction therapy temporarily takes attention away from pain while patients are engaged in the VR experience. In immersive VR, the user can interact with an artificial environment to treat chronic pain. In immersive VR, the user can interact with an artificial environment to treat chronic pain. One form of immersive VR is virtual embodiment. Virtual embodiment refers to the sense of owning a virtual body, from a first-person perspective, feeling the agent of the sensory feedback related to the actions of the virtual body. Through activation of somatosensory and premotor circuitry associated with the body parts that are embodied, the use of virtual embodiment as an immersive VR technique has been shown to influence pain-free range of motion in patients with unilateral chronic shoulder pain.
A case series was conducted in 2020, in which they describe two case studies that use embodiment in virtual reality as a treatment for chronic low back pain. The purpose of this case series was to determine the feasibility of a novel virtual reality-based digital therapeutic for the treatment of chronic pain. Two patients with chronic low back pain received seven sessions, two sessions per week, of a novel digital therapeutic that combines virtual embodiment with graded motor imagery to deliver functional rehabilitation exercises using an off-the-shelf virtual reality system. Pain catastrophizing scale was assessed before the first session and after the seventh session to determine the extent to which virtual embodiment training can improve psychological symptoms of chronic low back pain. In both patients, pain intensity was improved after individual sessions of virtual embodiment training. They concluded that embodiment in virtual reality improves symptoms of persistent chronic low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants consented to participate will be assigned a unique number. The detailed list will be kept confidentially under the custody of the Principal Investigator. Unique numbered envelop will be provided to the participant. The participant will tell his number to the receptionist. The receptionist will send the participant to treatment room according to randomly allocation list. An outcome assessor will fill the form after treatment.
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postpartum women with acute and chronic lumbopelvic pain.
- •Primary parous & multiparous women.
排除标准
- •Postpartum women with nausea, dizziness and blurred vision, high risk pregnancies.
- •Structural disorder of spinal alignment (Scoliosis, kyphosis, lordosis)
- •Traumatic/ Inflammatory / Infectious Conditions
- •Diagnosed stress / depression
- •History of spinal, pelvic, or femur surgery or previous fracture, neoplasm
- •Any Previous history of backache
研究组 & 干预措施
traditional exercises as control group
Traditional exercise as control group
Postpartum women in this group will receive an 18-minute training session that will start with pelvic floor muscle training with 3 sets of 12 repetitions of 3 seconds of contraction and 3 seconds of relaxation in a lying position. The second part will be performed with 2 sets of 5-minute training modules with 1-minute rest between modules. A five-exercise circuit will be performed with one minute per exercise where the aim is to achieve the maximum number of repetitions possible, and then move on to the next exercise. For the exercises 2 dumbbells of 1 kilogram will be required. The exercises will include Kegel pelvic floor exercise, dead weight lifts, wide back rows, lunges with rotation, good morning (hip hinge), and lateral side bends. These traditional exercises were designed to build strength and improve pelvic floor function, lumbo-pelvic pain mirroring under the supervision of physiotherapist.
干预措施: Traditional exercise as control group (Other)
VR Intervention Group Protocol
Experimental: Participants in the intervention group will undergo a virtual reality (VR)-based exercise program using Meta Quest 2 head-mounted displays (Meta Platforms Inc., USA) and the Lumbar Pain Rehab software provided by DynamicsVR (Dynamics VR S.L., Cadiz, Spain). The virtual reality (VR) intervention will consist of eight structured sessions designed to address postpartum lumbo-pelvic pain through the immersive, interactive training.
Each session incorporating pelvic floor muscle training using VR, consisting of three sets of 12 repetitions, with each contraction and relaxation phase lasting three seconds. In addition, patients engaged in two five-minute blocks of immersive VR activities with a two-minute rest interval, resulting in total session duration of 18 minutes.
干预措施: Traditional exercise as control group (Other)
VR Intervention Group Protocol
Experimental: Participants in the intervention group will undergo a virtual reality (VR)-based exercise program using Meta Quest 2 head-mounted displays (Meta Platforms Inc., USA) and the Lumbar Pain Rehab software provided by DynamicsVR (Dynamics VR S.L., Cadiz, Spain). The virtual reality (VR) intervention will consist of eight structured sessions designed to address postpartum lumbo-pelvic pain through the immersive, interactive training.
Each session incorporating pelvic floor muscle training using VR, consisting of three sets of 12 repetitions, with each contraction and relaxation phase lasting three seconds. In addition, patients engaged in two five-minute blocks of immersive VR activities with a two-minute rest interval, resulting in total session duration of 18 minutes.
干预措施: VR Intervention Group Protocol (Device)
结局指标
主要结局
Effect on lumbopelvic pain
时间窗: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
During pregnancy, women go through several hormonal and biomechanical changes as well as neuromuscular adaptations which could explain the development of lumbopelvic pain. Pregnancy-related hormonal changes, characterized by an increase in relaxin, estrogen and progesterone levels, are potentially linked to hyperlaxity of ligament and joint instability, thus contributing to lumbopelvic pain. In addition, biomechanical changes induced by the growing fetus, can modify posture, load sharing and mechanical stress in the lumbar and pelvic structures. Finally, neuromuscular adaptations during pregnancy include an increase in the activation of lumbopelvic muscles and a decrease in endurance of the pelvic floor muscles. Short Form McGill Pain Questionnaire(SF-MPQ) will be used to determine the intensity of pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Effect on disability due to lumbopelvic pain
时间窗: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Due to physiological changes the pregnant female experience lumber pain. to determine lumber pain Oswestry Disability Index (ODI) will be used. ODI scale will include following levels for assessment 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled
Effect on disability due to pelvic pain
时间窗: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Pelvic Floor Disability Index ( PFDI) will be used to assesses the distress of pelvic organ prolapse (POP), anorectal and urinary symptoms in three subscales, respectively, Pelvic Organ Prolapse Distress Inventory (POPDI-6), Colorectal-Anal Distress Inventory (CRADI-8) and Urinary Distress Inventory (UDI-6) .The PFDI-20 has 20 items and 3 scales of your symptoms. All items use the following format with a response scale from 0 to 4. Scale Scores
Effect on functioning
时间窗: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Patient Specific Functional Scale(PSFS) will be used. This scale will nominate 3 to 5 activities that they are unable to do or having difficulty doing because of their injury or problem. These activities are rated on an 11-point scale, where 0 is unable to perform the activity and 10 is able to perform the activity at preinjury level.
Level of Depression, anxiety & stress
时间窗: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
DASS (Depression anxiety stress scale)questionnaire will be used for assessment. The total score represents overall distress (0 to 30), with higher scores indicating more severe distress or a greater number of symptoms. Two subscales are presented: Anxiety-Stress: Items 1, 4, 6, 7, 8, 9 (raw score range = 0 to 18) Depression: Items 2, 3, 5, 10 (raw score range = 0 to 12)
To access intensity of Pain
时间窗: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Visual analog scale (VAS) will be used to determine the intensity of pain. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
condition-specific measure for women with pelvic girdle pain
时间窗: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Pelvic Girdle Questionnaire (PGQ) will be used .To calculate the total PGQ score, all scores are summarized and divided by the total possible score of 75 (maximum possible scores of 60 for activity and 15 for symptoms), subsequently recalculated to a percentage, resulting in percentage scores ranging from 0 (no disability) to 100 (severe disability).
次要结局
- Effect on lumbopelvic pain(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- Presence of Simulator Sickness(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- condition-specific measure for women with pelvic girdle pain(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- Effect on disability due to pelvic pain(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- Effect on disability due to lumbopelvic pain(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- Level of Depression, anxiety & stress(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- Effect on functioning(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- coping strategy of pain(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- To access fatigue(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- To acess breathlessness(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- To acess sleep quality and disturbance(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- Level of Urinary incontinence(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- Psychological assessment (Rumination, Magnification &Helplessness)(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
- To access fear of movement(Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).)
