Study protocol to report the effectiveness of virtual reality therapy in combination with physical therapy protocol for improving balance in traumatic lower limb amputees: A parallel, open-label, randomized controlled trial

Abstract

INTRODUCTION: Virtual reality (VR) intervention was found to be feasible in lower limb amputees (LLA). To best of our knowledge, only there is no randomized controlled trial available regarding the rehabilitation of LLA using VR. Evidence suggest that more researches for amputee rehabilitation using VR is warranted. OBJECTIVE: To compare the effectiveness of VR therapy as an additional therapeutic adjunct with physical therapy protocol on limits of stability and postural stability, pain and quality of life among LLA. METHODS: A total of 100 LLA will be recruited by the simple random sampling (random number generator) from JPN Apex Trauma Centre, AIIMS to participate in randomized controlled trial. Recruited LLA will be randomly divided into two groups, virtual reality therapy along with physical therapy protocol (VRT-PTP) group and physical therapy protocol (PTP) group. Duration of the treatment will be 30 minutes in one session/day for 4 days/week for 3 weeks. Thus, each LLA will receive 12 sessions in total. The Biodex Balance System for measuring dynamic balance, NPRS for pain and quality of life by WHO Quality of Life-BREF (WHOQOL-BREF) are the outcome measures will be recorded at baseline, end of 3-week post-intervention period. The follow-up will be taken at 6^th and 9^th week after enrollment. RESULTS: Normality of the collected data will be confirmed by Kolmogorov-Smirnov test. Statistical significance within and between the groups will be determined. Effect size and power analysis will be performed. CONCLUSION: This study will present data for the efficacy of the VRT in improving balance and gait in addition to PTP.