Effect of Robotic Gait on Functions in Cerebral Palsy
2026年4月28日 更新者：Sevgi Acar、Medipol University
The Effects of Robotic Rehabilitation in Addition to Neurodevelopmental Therapy on Lower Extremity and Trunk Functions in Children With Cerebral Palsy
Cerebral palsy (CP) is a condition characterized by various motor disorders and limitations caused by brain damage.
Neurodevelopmental treatment (NDT) is one of the primary approaches in the rehabilitation of individuals with CP.
In recent years, technological rehabilitation methods, including robotic rehabilitation, have become more widespread.
This study aimed to investigate the effects of robotic rehabilitation applied in addition to neurodevelopmental treatment on the lower extremity and trunk functions in children with CP.
Fifteen children with CP participated in the study.
The motor levels of the participants were assessed using the Gross Motor Function Classification System (GMFCS), gross motor functions with the Gross Motor Function Measure (GMFM-88), spasticity with the Modified Ashworth Scale (MAS), sitting balance with the Seated Postural Control Measure (SPCM) and Trunk Control Measurement Scale (TCMS), balance with the Becure Balance System and Timed Up and Go Test, and selective motor control with the Selective Control Assessment of the Lower Extremity (SCALE).
After these assessments, the participants received NDT five times a week for a total of 20 sessions, each lasting 45 minutes, followed by reevaluation.
After a two-week break, robotic rehabilitation was applied in addition to NDT for 20 sessions, with each session lasting 25 minutes, and evaluations were repeated.
調査の概要
研究の種類
介入
入学 (実際)
15
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Beykoz
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Istanbul、Beykoz、トルコ（Türkiye）、34810
- Istanbul Medipol University, Physiotherapy and Rehabilitation Department
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Diagnosed with cerebral palsy
- Classified as Level I-III according to the Gross Motor Function Classification System (GMFCS)
- Lower extremity Modified Ashworth Scale (MAS) score of 3 or less
- No skin lesions or active skin infections in the lower extremities
- Minimum height of 110 cm
Exclusion Criteria:
- History of lower extremity orthopedic surgery
- History of botulinum toxin type A (BTX-A) injection within the past 6 months
- History of epileptic seizures
- Inability to attend the intervention sessions regularly or maintain study
- Inability to understand and follow simple verbal commands
- Inability to establish and maintain cooperation during assessments and interventionscompliance
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：なし
- 介入モデル：単一グループの割り当て
- 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：Single Group: Sequential Conventional Treatment and Experimental Intervention
Participants followed a single-group sequential intervention design.
After baseline assessment (T0), participants received neurodevelopmental treatment (NDT) for 4 weeks (20 sessions, 5/week, 45 min), including weight-shifting exercises, facilitation techniques, sensory stimulation, strengthening, and proprioceptive training.
Assessments were repeated at Week 4 (T1).
After a 2-week washout period, participants underwent a combined intervention of NDT (20 min) and robotic rehabilitation (RB, 25 min) for 4 weeks (20 sessions, 5/week).
RB was performed using the LokoHelp Gait Trainer, a body-weight-supported treadmill system enabling gait training with adjustable speed and incline based on tolerance.
Final assessments were conducted at Week 10 (T2).
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Neurodevelopmental treatment (NDT) was applied as a conventional physiotherapy program focusing on facilitating normal movement patterns and improving postural control.
Each session lasted 45 minutes and included weight-shifting exercises in crawling, sitting, kneeling, and standing positions; facilitation techniques; proprioceptive, auditory, and visual stimulation; isolated strengthening exercises for upper and lower extremities; and proprioceptive training.
The intervention was delivered 5 times per week for 4 weeks (total of 20 sessions).
Robotic rehabilitation (RB) was administered using the LokoHelp Gait Trainer, a body-weight-supported treadmill system designed for locomotor training.
The device enables gait practice with appropriate posture and movement patterns without continuous manual assistance.
Each session included 25 minutes of robotic-assisted gait training, with speed and incline adjusted according to participant tolerance.
RB was applied 5 times per week for 4 weeks (total of 20 sessions) in combination with neurodevelopmental treatment.
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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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Selective Control Assessment of the Lower Extremity (SCALE)
時間枠：Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
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Selective motor control was assessed using the Selective Control Assessment of the Lower Extremity (SCALE).
SCALE evaluates selective voluntary motor control of the hip, knee, ankle, subtalar, and toe joints bilaterally.
Participants were instructed to perform each movement within 3 seconds.
Each joint was scored based on performance as follows: normal selective motor control (2 points), impaired selective motor control (1 point), and inability to perform selective motor control (0 points).
The total score was calculated by summing the scores of all joints.
The maximum possible score is 20 points (10 points for each extremity), and the minimum score is 0. Higher scores indicate better selective motor control.
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Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
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The Seated Postural Control Measure (SPCM)
時間枠：Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
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Seated postural control was assessed using the Seated Postural Control Measure (SPCM).
The scale evaluates postural alignment and functional performance in the sitting position.
It consists of three sections: demographic information, postural alignment during sitting, and upper extremity function.
Postural deviations are rated on a 4-point scale (1 = poor, 4 = good), with higher scores indicating better postural control.
The maximum score is 88 for the postural alignment section and 48 for the upper extremity function section.
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Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Gross Motor Function Measure (GMFM-88)
時間枠：Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
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Gross motor function was assessed using the Gross Motor Function Measure-88 (GMFM-88).
The scale consists of 88 items grouped into five domains: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running, and jumping (24 items).
It is used to evaluate and classify functional motor abilities in children with motor impairments.
Each item is scored on a 4-point scale ranging from 0 to 3. The maximum possible score is 264, and the minimum score is 0. Higher scores indicate better gross motor function and greater levels of functional independence.
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Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
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Trunk Control Measurement Scale (TCMS)
時間枠：Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
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Trunk control was assessed using the Trunk Control Measurement (TCMS), which evaluates both static and dynamic sitting balance.
The scale consists of two main domains subdivided into three sections with a total of 15 items.
It includes two items assessing static sitting balance and one domain assessing dynamic sitting balance parameters.
The total score ranges from 0 to 58, with higher scores indicating better trunk control.
Assessments were performed with children seated in a standardized position (hips and knees in 90° flexion, feet in contact with the ground, and without back support).
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Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
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Time Up and Go Test (TUG)
時間枠：Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
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Functional mobility, gait speed, postural balance, and dynamic stability were assessed using the Timed Up and Go (TUG) test.
Participants were instructed to stand up from a standard chair, walk 3 meters, turn around, walk back to the chair, and sit down again.
The total time required to complete the task was recorded in seconds.
The test was performed twice, and the best performance was used for analysis.
Higher completion time indicates poorer functional mobility and balance performance.
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Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
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Becure Balance System
時間枠：Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
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Static balance was assessed using a computerized balance platform system providing objective postural stability data.
Participants stood on a balance board in a double-leg stance for 30 seconds under two conditions: eyes open and eyes closed.
The system recorded center of pressure (CoP) displacement in the X-Y plane and postural sway area during standing.
Outcome variables included postural sway parameters reflecting static balance control.
Higher sway values indicate poorer postural stability.
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Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
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出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- El-Shamy SM, Abd El Kafy EM. Effect of balance training on postural balance control and risk of fall in children with diplegic cerebral palsy. Disabil Rehabil. 2014;36(14):1176-83. doi: 10.3109/09638288.2013.833312. Epub 2013 Sep 13.
- Carvalho I, Pinto SM, Chagas DDV, Praxedes Dos Santos JL, de Sousa Oliveira T, Batista LA. Robotic Gait Training for Individuals With Cerebral Palsy: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2017 Nov;98(11):2332-2344. doi: 10.1016/j.apmr.2017.06.018. Epub 2017 Jul 24.
- Gulzar A, Waris M; Qurat Ul Ain. Effects of 8 weeks functional training programme on posture control and functional mobility in spastic hemiplegic cerebral palsy. J Pak Med Assoc. 2022 Jul;72(7):1278-1281. doi: 10.47391/JPMA.3476.
- Wu YN, Hwang M, Ren Y, Gaebler-Spira D, Zhang LQ. Combined passive stretching and active movement rehabilitation of lower-limb impairments in children with cerebral palsy using a portable robot. Neurorehabil Neural Repair. 2011 May;25(4):378-85. doi: 10.1177/1545968310388666. Epub 2011 Feb 22.
- Ammann-Reiffer C, Bastiaenen CHG, Meyer-Heim AD, van Hedel HJA. Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT). J Pediatr Rehabil Med. 2020;13(2):137-148. doi: 10.3233/PRM-190614.
- Klobucka, S., Ziakova, E., & Klobucky, R. (2015). P178-2253: The effect of age on the improvement in motor function in patients with cerebral palsy after undergoing robotic-assisted locomotor therapy. European Journal of Paediatric Neurology, 19, S143-S144.
- Tarakcı, D., Emir, A., Avcıl, E., & Tarakcı, E. (2019). Effect of robot assisted gait training on motor performance in cerebral palsy: a pilot study. Journal of Exercise Therapy and Rehabilitation, 6(3), 156-162.
- Molteni F, Gasperini G, Cannaviello G, Guanziroli E. Exoskeleton and End-Effector Robots for Upper and Lower Limbs Rehabilitation: Narrative Review. PM R. 2018 Sep;10(9 Suppl 2):S174-S188. doi: 10.1016/j.pmrj.2018.06.005.
- Llamas-Ramos R, Sanchez-Gonzalez JL, Llamas-Ramos I. Robotic Systems for the Physiotherapy Treatment of Children with Cerebral Palsy: A Systematic Review. Int J Environ Res Public Health. 2022 Apr 22;19(9):5116. doi: 10.3390/ijerph19095116.
- Labaf S, Shamsoddini A, Hollisaz MT, Sobhani V, Shakibaee A. Effects of Neurodevelopmental Therapy on Gross Motor Function in Children with Cerebral Palsy. Iran J Child Neurol. 2015 Spring;9(2):36-41.
- Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.
- Reid SM, Modak MB, Berkowitz RG, Reddihough DS. A population-based study and systematic review of hearing loss in children with cerebral palsy. Dev Med Child Neurol. 2011 Nov;53(11):1038-45. doi: 10.1111/j.1469-8749.2011.04069.x. Epub 2011 Sep 6.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年2月15日
一次修了 (実際)
2022年12月15日
研究の完了 (実際)
2023年6月15日
試験登録日
最初に提出
2026年4月12日
QC基準を満たした最初の提出物
2026年4月28日
最初の投稿 (実際)
2026年5月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月5日
QC基準を満たした最後の更新が送信されました
2026年4月28日
最終確認日
2022年1月1日
詳しくは
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。