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Effects of Virtual Reality on Transtibial Amputation Physiotherapy Outcomes

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ClinicalTrials.gov Identifier: NCT03872193
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Fatih Erbahceci, Hacettepe University

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.

Condition or disease Intervention/treatment Phase
Virtual Reality Other: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One group only physiotherapy second group takes physiotherapy and virtual reality exercises.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Virtual Reality on Transtibial Amputation Ouality of Life,Performance, Balance,Prothesis Adaptation and Gait Outcomes
Actual Study Start Date : July 10, 2016
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : June 10, 2018

Arm Intervention/treatment
Experimental: Physio Therapy
We intervention this group some routine exercises. They had balance exercises, gait training,incline surface gait,bloked surface gait training and recreational activities. Extremity strengthenin exercises,balance exercises and increasing endurance are applied for this amputees.
Other: Exercise
Virtual Reality Exercies

Experimental: Virtual Reality
This group had physical therapy program plus virtual reality exercises. They had balance exercises, gait training,incline surface gait,bloked surface gait training and recreational activities. Extremity strengthenin exercises,balance exercises and increasing endurance are applied for this amputees. And virtual reality exercises were done for this group. Skiing,kayak, football,rafting and jumping activities were done in this exerciese.
Other: Exercise
Virtual Reality Exercies




Primary Outcome Measures :
  1. Quality of Life measured of individuals: SF-36 Scale [ Time Frame: 10 minute ]
    SF-36 Quality of Life Scale, higher values represent a better

  2. Balance Test [ Time Frame: 5 minute ]
    Single Leg Balance Test,higher values represent a better

  3. Performance Test [ Time Frame: 6 minute ]
    6 minute walk test,higher values represent a better

  4. Prothesis Satisfaction: Trinity Amputation Prothesis Experience Scale [ Time Frame: 5 minute ]
    Trinity Amputation Prothesis Experience Scale; 5 point likert scale,5-75 point, activity limitation,physicosocial adaptation,prothesis satisfaction

  5. Gait Parameters [ Time Frame: 6 minute ]
    Wearable Biometric Device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Fatih Erbahceci, Clinical Professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT03872193    
Other Study ID Numbers: Virtual Reality Physiotherapy
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatih Erbahceci, Hacettepe University:
Amputation
Virtual Reality
Rehabilitation