TheraTogs Effects on Balance and Mobility in Cerebral Palsy
The Effect of the Dynamic Orthotic Garment TheraTogs on Balance and Functional Mobility of Children and Adolescent With Cerebral Palsy: A Cross-Sectional Clinical Study
Cerebral Palsy (CP) is the most common cause of childhood disability, with an estimated prevalence of 17 million individuals worldwide. Children and adolescents with CP present impaired postural control and balance, negatively affecting their mobility and functional performance. The use of dynamic orthotic garments may contribute to the improvement of postural control, balance, and functional mobility in children and adolescents with CP.
The aim of the present study is to investigate the immediate effect of the dynamic orthotic garment TheraTogs on balance and functional mobility in children and adolescents with CP.
In this cross-sectional pilot study, children and adolescents with CP classified as levels I and II according to the Gross Motor Function Classification System (GMFCS), and with spasticity levels lower than +1 according to the Modified Ashworth Scale, will participate. Balance will be assessed using the Pediatric Balance Scale (PBS), while functional mobility will be evaluated with the Timed Up and Go (TUG) test and the 10 Meter Walk Test (10MWT). Each assessment will be performed twice by each participant, with and without the TheraTogs dynamic orthotic garment, in random order. Statistical analysis will be conducted using SPSS Statistics V29 software, with the level of significance set at p < 0.05.
調査の概要
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：Marina Karachanidi
- 電話番号：+30 6971906736
- メール：mscphys24003@uniwa.gr
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
- Diagnosis of unilateral or bilateral spastic Cerebral Palsy
- GMFCS level I or II
- MAS level lower than +1
- Ability to understand and follow instructions
- Ability to walk without assistive devices
Exclusion Criteria
- Use of medications affecting balance
- Hearing or visual impairments
- Intellectual disability
- Botulinum toxin (Botox) injection in the lower limbs within the previous 6 months
- Severe musculoskeletal deformities
- Surgery within the previous 6 months
- Uncontrolled seizures during the previous 6 months
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：クロスオーバー割り当て
- 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 |
|---|---|
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実験的：NO GARMENT FIRST, THEN GARMENT
Participants will perform three balance and functional mobility assessments, including the Pediatric Balance Scale, Timed Up and Go Test, and 10-Second Sit-to-Stand Test.
Following the initial assessment, participants will wear the orthotic garment and repeat the same assessments.
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Theratogs is a dynamic orthotic garment, made of a "breathable", lightweight, self-adhesive Velcro fabric.
It provides a gentle passive force for correcting imbalances or alignments through a combined system of the trunk and lower limbs, along with a system of customized external straps.
It is worn over the skin under clothing or over a diaper.
The patented soft foam material gently grips the user's soft tissues to create biomechanical changes that are essential for positive outcomes.
A variety of lengths, back sizes, stiffness diameters, and placement options optimize the therapeutic and orthotic effects.
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実験的：GARMENT FIRST, THEN NO GARMENT
Participants will initially perform the balance and functional mobility assessments while wearing the orthotic garment.
After removal of the garment, the Pediatric Balance Scale, Timed Up and Go Test, and 10-Second Sit-to-Stand Test will be repeated under the same conditions.
|
Theratogs is a dynamic orthotic garment, made of a "breathable", lightweight, self-adhesive Velcro fabric.
It provides a gentle passive force for correcting imbalances or alignments through a combined system of the trunk and lower limbs, along with a system of customized external straps.
It is worn over the skin under clothing or over a diaper.
The patented soft foam material gently grips the user's soft tissues to create biomechanical changes that are essential for positive outcomes.
A variety of lengths, back sizes, stiffness diameters, and placement options optimize the therapeutic and orthotic effects.
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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 |
|---|---|---|
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TIMED UP AND GO TEST
時間枠：1 HOUR
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The Timed Up and Go (TUG) test evaluates functional mobility.
The test requires a chair with armrests and back support, a measuring tape, adhesive tape, and a stopwatch.
The time required for the participant to stand up from the chair, walk a distance of three meters (with or without assistive devices), turn around, return, and sit down again is recorded.
The TUG test is considered a valid and highly reliable tool (ICC = 0.99) for evaluating functional mobility in children with CP.
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1 HOUR
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10 Meter Walk Test (10MWT)
時間枠：1 HOUR
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The 10 Meter Walk Test (10MWT) evaluates functional mobility by measuring walking speed.
Participants walk at their normal pace along a 14-meter walkway with or without assistive devices.
A stopwatch is used to record the time required to complete a 10-meter distance, excluding the first and last two meters to allow for acceleration and deceleration.
The test demonstrates high test-retest reliability and high correlation with gross motor function in children with CP.
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1 HOUR
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Pediatric Balance Scale (PBS)
時間枠：1 HOUR
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The Pediatric Balance Scale (PBS) is a modified version of the Berg Balance Scale designed to assess functional balance skills in children with mild to moderate motor impairments.
The scale consists of 14 balance-related items scored from 0 (lowest function) to 4 (highest function), with a maximum score of 56 and a minimum score of 0 .
The PBS has been translated into Greek and is considered a reliable and valid tool for assessing functional balance in children with CP.
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1 HOUR
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協力者と研究者
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
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