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临床试验/CTRI/2024/01/061490
CTRI/2024/01/061490已完成2 期

Effectiveness of Motion Minder Therapy (MoMT) on Fine Motor Skills Among Children with Spastic Hemiplegia

Jeevarathinam Thirumalai2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月22日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Shriners Hospital Upper Extremity Evaluation (SHUEE), Nine Hole Peg Test

研究概览

简要总结

Motion Minder Therapy (MoMT) is a targeted intervention for fine motor skill challenges in spastic hemiplegic cerebral palsy children, emphasizing affordability, particularly in middle-income countries like India. Diverging from previous models requiring extensive daily supervision of 5 to 6 hours , MoMT optimizes resources by utilizing smartwatches for a focused 1-hour intervention. The study employs a Pilot (Phase I) with 5 children and an Experimental (Phase II) design with 20 participants, comparing MoMT with Hand-Arm Bimanual Intensive Therapy. Materials range from smart watch to sensory tools, offering a comprehensive approach. Primary and secondary outcomes, assessed through the Assisting Hand Assessment and ABILHAND Kids questionnaire, contribute to a thorough evaluation. Statistical analysis, incorporating inferential and descriptive statistics with a paired t-test, aims to underscore MoMT’s effectiveness in addressing the complex challenges of fine motor skill enhancement in spastic hemiplegic cerebral palsy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Age Eligibility: Children within the age bracket of 5 to 12 years.
  • Manual Ability Classification System: Individuals falling into MACS categories I to III.
  • Bimanual Fine Motor Function (BFMF): Participants falling within the BFMF spectrum of levels I to III.
  • Modified Ashworth Scale (MAS): Participants falling within the MAS grade of I to III in upper extremity.
  • Communication Functional Classification System (CFCS): Individuals with a CFCS classification ranging from I to III.
  • Mini-Mental State Examination for Children (MMC): Individuals with MMC score of
  • Grasping and Releasing Proficiency: Proficiency in grasping and releasing lightweight objects, with a minimum extension of 20° in the wrist and 10° in all Five MCP joints in the affected hand.

排除标准

  • Presence of visual or auditory disorders.
  • History of Seizure, respiratory issues and presence of hand deformities.
  • Children who have undergone Botulinum neurotoxin injections or surgical interventions in the 6-month before study.

结局指标

主要结局

Shriners Hospital Upper Extremity Evaluation (SHUEE), Nine Hole Peg Test

时间窗: Following the baseline pre-test assessment, a post-test assessment will be conducted after 4 weeks.

次要结局

  • ABILHAND-KIDS questionnaire(Baseline pre-test assessment continued by after 4 weeks of post-test assessment)

研究者

发起方
Jeevarathinam Thirumalai
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jeevarathinam Thirumalai

Saveetha College of Physiotherapy

研究点 (2)

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