Clinical trial NCT05439967: The Effects of Augmented and Virtual Reality Gait Training on Patients With Parkinson's Disease
Official title: Investigation of The Effects of Augmented and Virtual Reality Gait Training on Balance and Walking in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Exercise
Virtual Reality
Balance
Gait
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Parkinson's Disease (PD) rehabilitation, the treadmill is used both in aerobic training and in gait training, as it provides more walking distance and can include body weight supported systems. It has been reported that the C-Mill VR+ device, which is a treadmill system with augmented and virtual reality (VR) technology, improves gait adaptation and reduces the risk of falling in individuals with early to mid-stage PD. Several publications augmented reality (AR) and VR applications in PD was focused on balance activities that do not include ambulation. In other studies in the literature, it was stated that further research are needed to better understand the effects of VR gait training on gait and balance in PD. It was also stated in these studies that the effects of VR gait training should be examined with more objective measurement methods. As a result, it is seen that there is a need for studies examining the effects of augmented and virtual reality trainings in PD with objective measurement methods. Therefore, our study aimed to examine the effects of AR and VR gait training on gait and balance in individuals with early to mid-stage PD.

Detailed description: Participants included in the study will randomly divide were randomly divided into 2 groups as intervention (IG, n=15) and control (CG, n=15). IG was given augmented and virtual reality gait training together with conventional training (CT). CG was given CT only. The training was applied 3 days per week for 6 weeks in both groups. All evaluations will be made by the same physiotherapist by meeting with participants face to face. Inclusion in the research will be on a voluntary basis. As outcome measures, motor symptoms, balance, balance confidence and gait analyses were performed before and after intervention.

Eligibility criteria: Inclusion Criteria:

* being diagnosed with Parkinson's Disease by a specialist physician
* being grade 1-3 on the Hoehn and Yahr Staging Scale
* being 40 years or older; and
* individuals agreed to be included in the study after adequate information was given about the study

Exclusion Criteria:

* People who standardised Mini-Mental State Examination score \< 24
* Having any cardiovascular, vestibular, musculoskeletal, or additional neurological disease.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS-III)-Baseline
timeFrame: Assessment will be conducted before intervention
measure: Unified Parkinson's Disease Rating Scale (UPDRS-III)-Post Intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Hoehn and Yahr Staging Scale -Baseline
timeFrame: Assessment will be conducted before intervention
measure: Hoehn and Yahr Staging Scale -Post Intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Huber 360° Evolution System-baseline
timeFrame: Assessment will be conducted before intervention
measure: Huber 360° Evolution System-Post Intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Berg Balance Scale (BBS)-Baseline
timeFrame: Assessment will be conducted before intervention
measure: Berg Balance Scale-Post Intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Activities-specific Balance Confidence Scale (ABC) -Baseline
timeFrame: Assessment will be conducted before intervention
measure: Activities-specific Balance Confidence Scale (ABC) -Post Intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Spatio-temporal gait analysis -Baseline
timeFrame: Assessment will be conducted before intervention
measure: Spatio-temporal gait analysis -Post Intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Timed Up and Go Test (TUG)- Baseline
timeFrame: Assessment will be conducted before intervention
measure: Timed Up and Go Test (TUG)- Post Intervention
timeFrame: Assessment will be conducted immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
References: