CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
Kinect Based Virtual Reality Training +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04862910
NCT04862910N/ACompleted

Effects of Kinect-based Virtual Reality Training on Bone Mineral Density, Fracture Risk, Physical Performance and Quality of Life in Postmenopausal Women With Osteopenia

Riphah International University·interventional·Posted Apr 28, 2021·Updated Nov 13, 2023

In Brief

A clinical study evaluating Kinect Based Virtual Reality Training and Control Group for Postmenopausal Osteopenia. Completed, enrolled 52 participants across 2 sites.

Detailed Summary

Osteopenia is a clinical term to define the declined Bone Mineral Density (BMD) as per the normal reference values but not low enough to meet osteoporotic diagnostic criteria. A Dual-energy x-ray absorptiometry (DXA) bone scan is used to diagnose decreased BMD. Osteopenia is, as described by the World Health Organization (WHO), a score ranging from -1 to -2.5, whereas Osteoporosis is diagnosed with values less than - 2.5. The risk of a decrease in BMD doubles as a woman goes into Menopause. The objective of this study will be to determine the effects of Kinect-based virtual reality training on BMD, fracture risk, physical function and Quality of life in postmenopausal women with Osteopenia. This study will be a Randomized controlled trial. The study will be conducted at Riphah Rehabilitation Center, Lahore. Duration of the study will be 18 months. The sample size will be calculated after the completion of the pilot study. Initial screening of the participants will be done as per screening protocol and participants fulfilling inclusion criteria will be randomly allocated into two groups. Group A will receive Kinect based virtual reality training along with routine diet and routine Medication. Group B will be controlled with routine diet and routine Medication. Participants of both groups will be assessed at baseline for BMD, risk of fracture, all Objective and subjective parameters of Physical Performance and Quality of Life. Post-treatment assessment of Physical performance measures and Quality of life will be done after the 12th and 24th week, while BMD and fracture risk will be measured only after the 24th week. BMD will be measured by Dual-Energy X-ray Absorptiometry (DEXA) for Lumbar spine (BMD), proximal femur (BMD), T-score and Z-score. Fracture risk will be calculated by FRAX score, which estimates a fracture's probability within the next ten years. Physical Performance will be assessed by Time Up and Go Test (TUG), Functional Reach Test, Five Times Sit to Stand Test, Grip strength, Fall Efficacy Scale International, Borg revised category-ratio scale (0 to 10 scale) and Dyspnea index. Urdu Version of ECOS-16 will be used for the evaluation of health-related Quality of life (HRQOL). Data will be analyzed on SPSS-25.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPakistan
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 28, 2021
Enrollment StartSep 1, 2021
Primary CompletionJun 1, 2023
Study CompletionJun 15, 2023
TodayJul 1, 2026
Enrollment to primary: 1.8 yearsPosted 5.2 years ago

Interventions

Kinect Based Virtual Reality Trainingother

The participant will receive the game instructions from the examiner.Protocol will be implemented 3 steps Warm Up phase Activity phase and cool down phase. The games will be played under the supervision and guidance of the therapist.Games are selected from Kinect games Kinect Sports Kinect Adventures and Your Shape Fitness Evolved. Three treatment sessions per week will be given to each participant. Total duration of each treatment session will be 45 Minutes.Participants will be instructed to walk outdoors for 30 Minutes daily. Routine Medication and routine diet will be continued.

Control Groupother

* They will be instructed to walk outdoors daily for 30 Minutes. * They will continue their daily activities with a routine diet and routine Medication