Whole-body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Duchene Muscular Dystrophy
調査の概要
詳細な説明
Duchenne Muscular Dystrophy (DMD) is a progressive X-linked neuromuscular disorder characterized by muscle fiber degeneration due to mutations in the dystrophin gene (Birnkrant et al., 2018). As muscle weakness advances, children with DMD experience impaired postural control, reduced balance function, and increased risk of falls, all of which significantly contribute to limitations in daily activities and loss of independence (Ricotti et al., 2016). Early therapeutic interventions are essential to slow functional decline and promote motor stability for as long as possible.
Whole-body vibration (WBV) has emerged as a potential modality to enhance neuromuscular activation, proprioception, and balance in individuals with muscle weakness or neurological impairments. Studies suggest that low-frequency WBV can improve muscle spindle sensitivity, postural reactions, and balance performance in pediatric and neuromuscular populations (Brunetti et al., 2015; Saquetto et al., 2015). Although research involving children with DMD is limited, preliminary evidence indicates that WBV may transiently enhance motor function without excessive muscle strain.
Gravity-force stimulation (GFS)-often delivered through tilt platforms, vertical acceleration devices, or graded gravitational loading-has been proposed as another means to stimulate proprioceptive pathways and increase postural control. GFS can enhance sensory input from weight-bearing structures and may promote improved equilibrium response strategies in children with neuromotor impairments (Bates & Hanson, 2019). However, its application specifically in DMD remains under-studied, and direct comparisons with WBV have not been adequately explored.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Giza Governorate
-
Giza、Giza Governorate、エジプト、11432
- Cairo University
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Children diagnosed with Duchenne Muscular Dystrophy (DMD).
- Age between 6 and 10 years.
- Lower extremity and trunk muscle strength graded at least 3+, based on the manual muscle testing criteria.
- Ability to move the upper and lower limbs within functional limits without severe joint restriction.
- Ability to walk independently without assistive devices, corresponding to Levels I and II of the Ambulation Function Classification System for DMD (AFCSD).
Exclusion Criteria:
- Presence of cardiopulmonary dysfunction or congenital or acquired skeletal abnormalities that may interfere with participation.
- History of lower-limb surgical procedures.
- Neurological conditions affecting balance or gait, or evidence of poor motor development not attributable to DMD.
- Behavioral disorders that would prevent cooperation during assessment or intervention sessions.
- Overweight status, defined as a body mass index (BMI) greater than 25 kg/m²
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:whole body vibration group
whole body vibration intervention
|
we use vibrating platform •
|
|
実験的:force gravity stimulation group
force gravity stimulation intervention
|
Thirty children received: • Gravity-Force Stimulation (GFS), which included:
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
abdominal muscle thickness
時間枠:3 months
|
measure the abdominal muscle thickness
|
3 months
|
|
postural stability
時間枠:3 months
|
• BIODEX MEDICAL SYSTEM used for assessment of postural stability and balance
|
3 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Mostafa S. Ali、Cairo University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- P.T.REC/012/006366
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。