The Effects of Lokomat Virtual Reality Applications on Balance and Gait in Stroke Patients
연구 개요
상태
정황
상세 설명
Stroke is an important health problem worldwide. Emotional, cognitive, sensory and motor problems occur with stroke. Motor problems are especially balance and walking problems and they are related to each other. So balance and gait rehabilitation are primary goals in stroke.
Although the first study to support the efficacy of Lokomat is that Lokomat is superior to conventional physiotherapy in walking, there are also studies reporting that there is no difference between the effects of Lokomat and conventional physiotherapy and that conventional physiotherapy is superior. In the light of all these studies, the effectiveness of applying robotic systems together with conventional physiotherapy is widely accepted.
Robot Assisted Walking Training has many components such as guiding force, walking speed, body weight support. Virtual reality is one of these components and there is literature in which Lokomat virtual reality applications are effective on balance and walking. Although the virtual reality effect is emphasized for Lokomat, there is a lack of literature on the specific effect of different virtual reality applications. In our study, it was aimed to examine the changes caused by different Lokomat virtual reality applications in the spatiotemporal parameters of balance and gait.
Method: This study was conducted to examine the effects of Lokomat VR applications on balance and spatiotemporal parameters of gait in patients with chronic stroke; It is a prospective, randomized controlled, single-blind study. The study will be carried out in a single-blind manner, and the evaluator will not know which group the individual is in. 56 individuals with chronic stroke included our study. All individuals have been informed about the study and read and signed the consent form stating that they voluntarily participated in the study. For balance evaluation we used Berg Balance Scale and Huber 360 device, which measures postural stability and limits of stability. And for gait evaluation we used 10 MWT, 6 MWT and spatiotemporal gait analysis for C-Mill VR+.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Ankara, 칠면조, 06000
- Ankara City Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Clinical diagnosis is stroke
- The time period have to be chronic period (+6 months)
- The patient must have the ability to walk with or without support
- The patiens should be able to understand Lokomat exercises
Exclusion Criteria:
- Any condition that may prevent walking with Lokomat
- Not volunteering to participate in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Lokomat Group I (Endurance)
|
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
|
|
실험적: Lokomat Group II (Attention and Motivation)
|
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
|
|
실험적: Lokomat Group III (Activity Timing)
|
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
|
|
다른: Control
-Only Conventional Physiotherapy
|
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in 6 MWT
기간: 6 weeks after treatment
|
6 Minutes Walk Test is a test using for walking distance.
We evaluated the change in walking distance with 6 MWT.
|
6 weeks after treatment
|
|
Change in 10 MWT
기간: 6 weeks after treatment
|
10 MWT is a test using for evaluate the gait speed.
Gait speed is a spatiotemporal parameter.
|
6 weeks after treatment
|
|
Change in BBS
기간: 6 weeks after treatment
|
Berg Balance Scale used for balance assesment.
The scale consists of 14 items and each item gets a score between 0-4.
As a result, the person evaluated gets a score between 0-56 on the berg balance scale.
A higher score means the person has better balance skills.
|
6 weeks after treatment
|
|
Change in Limits of Stability
기간: 6 weeks after treatment
|
Limits of Stability (LoS) are defined as the points at which the center of gravity (CoG) approaches the limits of the base of support (BoS) and a correction strategy is required to return the center of mass (CoM) to within the BoS.
In other words, LoS is the amount of maximum excursion an individual is able to intentionally cover in any direction without losing his/her balance or taking a step.
We used Huber 360 device to evaluate the LoS.
|
6 weeks after treatment
|
|
Change in Spatiotemporal Gait Analysis
기간: 6 weeks after treatment
|
Spatiotemporal gait analysis gives spatial (distance) parameters along with temporal (time) parameters.
|
6 weeks after treatment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Spatial Symmetry
기간: 6 weeks after treatment
|
It is the ratio of the hemiplegic side step lenght to the non-hemiplegic side step lenght.
|
6 weeks after treatment
|
|
Change in Temporal Symmetry
기간: 6 weeks after treatment
|
For temporal symmetry we used the description "Gait Symmetry".
Gait symmetry is calculated by the ratio of the hemiplegic side sway phase to the hemiplegic side stance phase ratio and the ratio of the non-hemiplegic side sway phase to the non-hemiplegic side stance phase ratio.
|
6 weeks after treatment
|
|
Change in Postural Stability
기간: 6 weeks after treatment
|
Postural stability refers to the ability to maintain your body in a position to effectively complete a task or demand, using large muscle groups at the shoulders, trunk, and hips.
We used Huber 360 device to evaluate the postural staiblity.
The assesments were combination of opened and closed eyes.
We recorded the COP vellocity and area.
|
6 weeks after treatment
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .