The Impact of Innovative Technology Strategies on Implementing Exercise Programs Using Fully Immersive Virtual Reality for Postpartum Women

NCT05921747 | Active Not Recruiting DMC

• 1 other identifier: SSAHS 2023/01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Partum Lumbopelvic Pain

Outcome Measures

Primary Outcomes (1)

• To access intensity of Pain

  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')

  Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).

Secondary Outcomes (14)

• Level of Urinary incontinence

  Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).

• 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).

• To access fear of movement

  Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).

Other Outcomes (1)

• Presence of Vestibular basilar artery insufficiency (VBI)

  Pre Treatment one time (Day 0)

Study Arms (2)

traditional exercises as control group

OTHER

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.

Other: Traditional exercise as control group

VR Intervention Group Protocol

EXPERIMENTAL

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.

Other: Traditional exercise as control group; Device: VR Intervention Group Protocol

Interventions

Traditional exercise as control group OTHER

Standard Traditional exercise program: The traditional exercises will include Kegel pelvic floor exercise, dead weight lifts, wide back rows, lunges with rotation, good morning (hip hinge), and lateral side bends. . Pre and post measurement will be taken before and after the session.

VR Intervention Group Protocol; traditional exercises as control group

VR Intervention Group Protocol DEVICE

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. A familiarization session will be conducted prior to the intervention to acclimate participants to the VR environment. This will include modified pelvic floor training (3 sets of 8 repetitions; 3 seconds of contraction.

Also known as: VR Intervention Group Protocol as experimental group

VR Intervention Group Protocol

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Post partum Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postpartum women with acute and chronic lumbopelvic pain.
• Primary parous \& multiparous women.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shalamar Institute of Health Sciences: lead

Study Sites (1)

Shalamar School of Allied Health Sciences

Lahore, Punjab Province, 54840, Pakistan

Location

Related Publications (13)

• Vesentini G, Prior J, Ferreira PH, Hodges PW, Rudge M, Ferreira ML. Pelvic floor muscle training for women with lumbopelvic pain: A systematic review and meta-analysis. Eur J Pain. 2020 Nov;24(10):1865-1879. doi: 10.1002/ejp.1636. Epub 2020 Sep 6.

  PMID: 32735717 BACKGROUND

• Daneau C, Abboud J, Marchand AA, Houle M, Pasquier M, Ruchat SM, Descarreaux M. Mechanisms Underlying Lumbopelvic Pain During Pregnancy: A Proposed Model. Front Pain Res (Lausanne). 2021 Dec 2;2:773988. doi: 10.3389/fpain.2021.773988. eCollection 2021.

  PMID: 35295430 BACKGROUND

• Catena RD, Wolcott WC. Self-selection of gestational lumbopelvic posture and bipedal evolution. Gait Posture. 2021 Sep;89:7-13. doi: 10.1016/j.gaitpost.2021.06.022. Epub 2021 Jun 26.

  PMID: 34217002 BACKGROUND

• Starzec-Proserpio M, Wegrzynowska M, Sys D, Kajdy A, Rongies W, Baranowska B. Prevalence and factors associated with postpartum pelvic girdle pain among women in Poland: a prospective, observational study. BMC Musculoskelet Disord. 2022 Oct 20;23(1):928. doi: 10.1186/s12891-022-05864-y.

  PMID: 36266709 BACKGROUND

• Trujillo MS, Alvarez AF, Nguyen L, Petros J. Embodiment in Virtual Reality for the Treatment of Chronic Low Back Pain: A Case Series. J Pain Res. 2020 Nov 25;13:3131-3137. doi: 10.2147/JPR.S275312. eCollection 2020.

  PMID: 33269003 BACKGROUND

• Luo Y, He L, Li Y, Xie J, Gong S, Zhang Q, Yin E, Gu M, Yi C. Sacral osteotomy combined with triangular osteosynthesis in the treatment of malunion and nonunion of vertically displaced pelvic fractures. J Orthop Surg Res. 2022 Sep 5;17(1):409. doi: 10.1186/s13018-022-03296-x.

  PMID: 36064584 BACKGROUND

• Beales D, Lutz A, Thompson J, Wand BM, O'Sullivan P. Disturbed body perception, reduced sleep, and kinesiophobia in subjects with pregnancy-related persistent lumbopelvic pain and moderate levels of disability: An exploratory study. Man Ther. 2016 Feb;21:69-75. doi: 10.1016/j.math.2015.04.016. Epub 2015 May 1.

  PMID: 25997987 BACKGROUND

• Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.

  PMID: 30282349 RESULT

• Ehsani F, Sahebi N, Shanbehzadeh S, Arab AM, ShahAli S. Stabilization exercise affects function of transverse abdominis and pelvic floor muscles in women with postpartum lumbo-pelvic pain: a double-blinded randomized clinical trial study. Int Urogynecol J. 2020 Jan;31(1):197-204. doi: 10.1007/s00192-019-03877-1. Epub 2019 Apr 23.

  PMID: 31016337 RESULT

• Sonmezer E, Ozkoslu MA, Yosmaoglu HB. The effects of clinical pilates exercises on functional disability, pain, quality of life and lumbopelvic stabilization in pregnant women with low back pain: A randomized controlled study. J Back Musculoskelet Rehabil. 2021;34(1):69-76. doi: 10.3233/BMR-191810.

  PMID: 32986655 RESULT

• Matamala-Gomez M, Slater M, Sanchez-Vives MV. Impact of virtual embodiment and exercises on functional ability and range of motion in orthopedic rehabilitation. Sci Rep. 2022 Mar 23;12(1):5046. doi: 10.1038/s41598-022-08917-3.

  PMID: 35322080 RESULT

• Daneau C, Marchand AA, Bussieres A, O'Shaughnessy J, Ruchat SM, Descarreaux M. Effects of a motor control exercise program on lumbopelvic pain recurrences and intensity in pregnant women with a history of lumbopelvic pain: a study protocol for a randomized controlled feasibility trial. Pilot Feasibility Stud. 2022 Mar 21;8(1):65. doi: 10.1186/s40814-022-01024-0.

  PMID: 35313988 RESULT

• Kale, A.A. and Pathan, N.M., 2019. Effect of Core Stabilisation Exercises in Postnatal Women with Lumbo-Pelvic Instability. Indian Journal of Physiotherapy and Occupational Therapy, 13(2), p.19.

  RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Javeria Dr Aslam, Ph.D

  Shalamar Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

• Carlos R. Morales, Ph.D

  Universided Europea Madrid, Spain

  STUDY DIRECTOR

• RAQUEL DIAZ-MECO, Ph.D

  Universided Europea Madrid, Spain

  STUDY DIRECTOR

• Alba P. Alemany, Ph.D

  Department of Radiology & Physical Medicine, Complutense University of Madrid, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After selecting the desired sample size (tentative 17) the subjects will be randomly allocated to the both treatment groups

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: June 27, 2023
• Study Start: August 2, 2023
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)