Effects of Virtual Reality on Transtibial Amputation Physiotherapy Outcomes

NCT ID: NCT03872193

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-10
• Study Completion Date: 2018-06-10

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.

Conditions

Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Virtual Reality Exercies

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Virtual Reality Exercies

Interventions

Exercise

Virtual Reality Exercies

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Fatih Erbahceci

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Yildirim Sahan T, Erbahceci F. Effects of Virtual Reality on Transtibial Amputation Rehabilitation Outcomes: A Randomized Study. Games Health J. 2023 Dec;12(6):459-467. doi: 10.1089/g4h.2023.0052. Epub 2023 Nov 7.

Reference Type: DERIVED

PMID: 37934289 (View on PubMed)

B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.

Reference Type: DERIVED

PMID: 37276273 (View on PubMed)

Other Identifiers

Virtual Reality Physiotherapy

Identifier Type: -

Identifier Source: org_study_id