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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Agnieszka Guzik
- 電話番号：+48 17 851 8965
- メール：aguzik@ur.edu.pl
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：コントロール：標準リハビリテーション
|
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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Gait speed - 10-meter walk test
時間枠：Baseline (Day 1)
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Baseline (Day 1)
|
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Gait speed - 10-meter walk test
時間枠：Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
|
Walking Endurance - 6-Minute Walk Test
時間枠：Baseline (Day 1)
|
Baseline (Day 1)
|
|
Walking Endurance - 6-Minute Walk Test
時間枠：Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
|
Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
時間枠：Baseline (Day 1)
|
Baseline (Day 1)
|
|
Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
時間枠：Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
|
Lower Limb Loading Symmetry - Two-Scale Test
時間枠：Baseline (Day 1)
|
Baseline (Day 1)
|
|
Lower Limb Loading Symmetry - Two-Scale Test
時間枠：Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gait and Balance - Dynamic Gait Index
時間枠：Baseline (Day 1)
|
Baseline (Day 1)
|
|
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Gait and Balance - Dynamic Gait Index
時間枠：Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
|
|
Gait Asymmetry - Wisconsin Gait Scale
時間枠：Baseline (Day 1)
|
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.
|
Baseline (Day 1)
|
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Gait Asymmetry - Wisconsin Gait Scale
時間枠：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)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Agnieszka Guzik、Rzeszów, Al. Rejtana 16C, Poland 35-310
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1/11/2025
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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