Clinical trial NCT03872193: Effects of Virtual Reality on Transtibial Amputation Physiotherapy Outcomes
Official title: Effects of Virtual Reality on Transtibial Amputation Ouality of Life,Performance, Balance,Prothesis Adaptation and Gait Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Keywords: Amputation
Virtual Reality
Rehabilitation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group only physiotherapy second group takes physiotherapy and virtual reality exercises.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare the effects of virtual reality applications on quality of life, performance, balance, prosthesis adaptation and gait parameters in individuals with transtibial amputation. 20 Transtibial amputee were included in study. All participants were using transtibial prothesis with active vacuum system at least 1 year. Participants were divided into two groups. While a group of virtual reality applications were being performed additionally standart physiotherapy, only standard physiotherapy methods were applied in the second group. Balance and gait practices were performed for each group. Individuals were treated for 3 days a week for 4 weeks, and individuals were evaluated before and after treatment. Individuals were evaluated for quality of life, performance, balance, prosthesis adaptation and time-distance parameters of walking.

Detailed description: The aim of this study is to compare the effects of virtual reality applications on quality of life, performance, balance, prosthesis adaptation and gait parameters in individuals with transtibial amputation.20 transtibial amputee with 36 mean age were included in study. All participants were using transtibial prothesis with active vacuum system at least 1 year. Participants were divided into two groups. While a group of virtual reality applications were being performed, standard physiotherapy methods were applied in the second group. Balance and gait practices were performed for each group. Individuals were treated for 3 days a week for 4 weeks, and individuals were evaluated before and after treatment. Individuals were evaluated for quality of life, performance, balance, prosthesis adaptation and time-distance parameters of walking.

For this purpose, SF-36 Questionnaire, 6-minute walking test, one leg rest time, Trinity Amputation and Prosthetic Experience Scale, wearable biometric device and footprint method were utilized. There was a statistically significant difference between the two groups in pre-treatment and post-treatment performance, balance and gait parameters in the groups of individuals (p \<0.05). The quality of life pain parameter was statistically decline in the group receiving virtual reality (p\<0.05). On the other hand, significant differences in the quality of life and prosthesis adaptation of the individuals were not found between the groups (p\> 0.05). The results of this study showed that virtual reality practices and standard physiotherapy methods are effective on performance, balance and walking in transtibial amputee rehabilitation. It is thought that it will be important to perform virtual reality applications in amputee rehabilitation separately in both methods, in addition to standard physiotherapy methods, to include in rehabilitation process, to bring an ability of alternative application to professionals working in this area and to work about amputees with using different suspension systems and with different amputation levels.

Eligibility criteria: Inclusion Criteria:

* transtibial and unilateral amputation
* At least 1 year prothesis usage, 18- 65 year age,
* At least 15 min independent walking ability,
* Stabile stump volume,
* Standart stump lentgh,
* Enough kognition for evaluation and tests.

Exclusion Criteria:

* walking and other activities to prevent; shortness of muscle, limitation of joint motion and phantom pain in stump, presence of any discomfort or systemic health problem that may affect the gait outside the amputation
* presence of visual problems to prevent participation in virtual reality applications,
* use of walking aids

Primary outcomes:
measure: Quality of Life measured of individuals: SF-36 Scale
timeFrame: 10 minute
measure: Balance Test
timeFrame: 5 minute
measure: Performance Test
timeFrame: 6 minute
measure: Prothesis Satisfaction: Trinity Amputation Prothesis Experience Scale
timeFrame: 5 minute
measure: Gait Parameters
timeFrame: 6 minute
Secondary outcomes:
Other outcomes:
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