Combined effect of galvanic vestibular stimulation (GVS) with vestibular exercises on sitting balance and functional independence in individuals with spinal cord injury

Background / Introduction / Review of Literature

·        ***Background :***Spinal cord injury (SCI) is a lesion to the spinal cord resulting from a traumatic injury, causing neurological changes and compromising spinal cord activity to varying degrees. The global incidence of SCI is estimated to range between eight and 246 cases per million persons.

·        Introduction : Most of the functional activities, such as eating, dressing, and transfers, are performed in a sitting position by people who have paraplegia. Hence sitting balance training is the main focus in this area.

·        Review of Literature : Earlier research conducted by Anna et al.(2022)reported that Galvanic vestibular stimulation was an effective technique to improve balance in neurological conditions like stroke, while the study carried out by Zhe cui (2024) concluded that gaze stabilization exercises improve sitting balance in stroke. These studies focused on one training type in isolation only.

·       Lacunae in Literature : A critical analysis of both these researches revealed a significant lacunae in the existing literature, wherein individual benefits of both the training protocols are well-documented, but there is a scarcity of research that conducts combined effectiveness of both techniques. The present study is designed to fill this gap, as it aims to combine the effects of galvanic vestibular stimulation(gvs) with vestibular exercises on sitting balance and functional independence in individuals with spinal cord injury

Objectives and Hypothesis

Primary objective : To find effect of active Galvanic vestibular stimulation  combined with Vestibular rehabilitation training to improve sitting balance compared to sham stimulation combined with vestibular rehabilitation training.

Secondary objective ***:***To find effect of active Galvanic vestibular stimulation combined with Vestibular rehabilitation training to improve functional independence compared to sham stimulation combined with vestibular rehabilitation training.

Null Hypothesis : Neither the galvanic vestibular stimulation combined with vestibular exercises nor vestibular exercises alone has any significant impact on improving sitting balance and functional independence in individulas with spinal cord injury.

Alternate Hypothesis : Both the galvanic vestibular stimulation combined with vestibular exercises and vestibular exercises alone has significant impact on improving sitting balance and functional independence in individulas with spinal cord injury.

Material and Methods

·        Study Design : The study follows a randomized control study design with assessment at two time intervals. The baseline or pre -test is at week 0, a post -test after 4 weeks .

·        Sample Size and method : The total Sample Sizeis 28 divided into two groups of 14 each i.e. one active gvs group and one sham stimulation group. The Sample Size Calculation was performed using G*Power software with a statistical power of 80%, and an alpha error of 5% and a 95% confidence interval.

·        Enrolment Period :  The Durationof the study is4weeks.

·        Total Study Duration : The entire study is expected to be completed within 5 to 6 months.

·        Inclusion and Exclusion Criteria : This study shall includemale and female, traumatic spinal cord injury individuals aged 18 to 60 years having ASIA-AIS A &B . Indiviuals with any musculoskeletal injury, head injury ,metals implants  or having complications like pressure sores and contractures will be excluded.

·        Study Procedure : The participants for the research shall be recruited from ISIC IRS vasant kunj, New Delhi via a purposive sampling method. Participants will be randomly assigned into 2 parallel groups using a computer-generated randomisation software. The active group will undergo a galvanic vestibular stimulation with vestibular exercises  while the sham stimulation group will undergo a placebo stimulation with vestibular exercises program. Groups shall follow the training five times a week for 4  weeks along with their conventional rehabilitation..

·        Assessment Tools : To evaluate outcomes, sitting balance will be tested using the FIST-SCI Modified functional reach test (MFRT),prokin-252 technobody,and functional independence will be tested by SCIM-III.

 Statistical Analysis Plan :

The data will be analysed in SPSS software version 25 with descriptive statistics for both categorical (age, gender) and continuous data (Fist-SCI,MFRT,SCIM-III) via frequency, percentage and mean, median, standard deviation respectively. Normality will be checked using the Shapiro - Wilk test. Depending upon the distribution either parametric tests T-tests or non-parametric test Wilcoxon signed rank test will be used with a statistical significance level of 5%.