- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07568821
Effectiveness of VR Rehabilitation for People With Asymmetrical Gait Patterns
Evaluation of the Effectiveness of Rehabilitation in Patients With Gait Pattern Asymmetry Using a Virtual Reality
A randomized comparative study will be conducted to evaluate the rehabilitation process using a VR-based application versus conventional therapy in 40 patients (sample size determined using a sample size calculator). After meeting the eligibility criteria, participants will be randomly assigned to two groups: the experimental group (20 patients with gait pattern asymmetry), performing a gait training program using a VR rehabilitation application, and the control group (20 patients with gait pattern asymmetry), performing only a conventional gait training program.
Participants in both groups will take part in a 2-week rehabilitation program (Monday to Friday), with daily training sessions lasting up to 2 hours. Patient assessment will be conducted twice: an initial evaluation before the start of the intervention (Assessment I) and a follow-up evaluation after completion of the 2-week program (Assessment II), at the same time of day, under the same conditions, and using the same measurement tools.
연구 개요
상태
상세 설명
Individuals with a diagnosed and clinically confirmed asymmetry of gait pattern will be eligible for inclusion in the study.
Exclusion criteria: Active rheumatic diseases, cancer, advanced diabetes, cardiovascular diseases, and other conditions affecting the safety and effectiveness of rehabilitation, Contraindications to VR therapy (epilepsy, motion sickness, dizziness, nausea), Lower limb injuries or surgeries within the last 6 months, Severe mental disorders preventing understanding of instructions.
Training for both groups will include balance and coordination exercises, proprioceptive stimulation, and exercises aimed at improving step length symmetry and lower limb loading. Additionally, the experimental group will receive 15 to 30 minutes (adjusted to the patient's abilities) of training using a VR application in a virtual environment, providing real-time feedback on body position, step length, and balance. The effects of gait training will be evaluated using the following measures: gait speed, walking endurance, independent mobility and risk of falls, balance, gait symmetry, spinal mobility, and functional performance.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Agnieszka Guzik
- 전화번호: +48 17 851 8965
- 이메일: aguzik@ur.edu.pl
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Diagnosed and clinically confirmed gait pattern asymmetry in the course of neurological diseases
- Informed consent to participate in the study and willingness to comply with rehabilitation recommendations
Exclusion Criteria:
- Active rheumatic diseases, cancer, advanced diabetes, cardiovascular diseases, and other conditions that may affect the safety and effectiveness of rehabilitation
- Contraindications to VR therapy (epilepsy, motion sickness, dizziness, nausea)
- Lower limb injuries or surgeries within the last 6 months
- Severe mental disorders preventing understanding of instructions
- Lack of informed consent to participate in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 대조군: 표준 재활
|
The control group will participate only in a conventional gait training program.
Participants will take part in a 2-week rehabilitation program (Monday to Friday), with daily training sessions lasting up to 2 hours.
Training will include balance and coordination exercises, proprioceptive stimulation, and exercises aimed at improving step length symmetry and lower limb loading.
|
|
실험적: VR Therapy and Standard Rehabilitation
|
The experimental group will participate in a gait training program using a VR rehabilitation application.
Participants will take part in a 2-week rehabilitation program (Monday to Friday), with daily training sessions lasting up to 2 hours.
Training will include balance and coordination exercises, proprioceptive stimulation, and exercises aimed at improving step length symmetry and lower limb loading.
Additionally, the experimental group will receive 15 to 30 minutes (adjusted to the patient's abilities) of training using a VR application in a virtual environment, providing real-time feedback on body position, step length, and balance.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Gait speed - 10-meter walk test
기간: Baseline (Day 1)
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Baseline (Day 1)
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Gait speed - 10-meter walk test
기간: Immediately after therapy completion (Day 10)
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Immediately after therapy completion (Day 10)
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Walking Endurance - 6-Minute Walk Test
기간: Baseline (Day 1)
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Baseline (Day 1)
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Walking Endurance - 6-Minute Walk Test
기간: Immediately after therapy completion (Day 10)
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Immediately after therapy completion (Day 10)
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Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
기간: Baseline (Day 1)
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Baseline (Day 1)
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Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
기간: Immediately after therapy completion (Day 10)
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Immediately after therapy completion (Day 10)
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Lower Limb Loading Symmetry - Two-Scale Test
기간: Baseline (Day 1)
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Baseline (Day 1)
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Lower Limb Loading Symmetry - Two-Scale Test
기간: Immediately after therapy completion (Day 10)
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Immediately after therapy completion (Day 10)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Gait and Balance - Dynamic Gait Index
기간: Baseline (Day 1)
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Baseline (Day 1)
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Gait and Balance - Dynamic Gait Index
기간: Immediately after therapy completion (Day 10)
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Immediately after therapy completion (Day 10)
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Gait Asymmetry - Wisconsin Gait Scale
기간: Baseline (Day 1)
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The Wisconsin Gait Scale is an observational tool used to assess gait quality.
Scores range from 13.35 to 42, with higher scores indicating worse gait performance.
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Baseline (Day 1)
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Gait Asymmetry - Wisconsin Gait Scale
기간: Immediately after therapy completion (Day 10)
|
The Wisconsin Gait Scale is an observational tool used to assess gait quality.
Scores range from 13.35 to 42, with higher scores indicating worse gait performance.
|
Immediately after therapy completion (Day 10)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Agnieszka Guzik, Rzeszów, Al. Rejtana 16C, Poland 35-310
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
기타 연구 ID 번호
- 1/11/2025
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미국 FDA 규제 기기 제품 연구
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