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临床试验/CTRI/2026/02/102992
CTRI/2026/02/102992尚未招募不适用

Goal-oriented intervention for functional goal and motor skill in infant with or at risk of neuromotor dysfunction.

KAHER INSTITUTE OF PHYSIOTHERAPY1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2026年2月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
21
试验地点
1

研究概览

简要总结

This study investigates the effect of an individualized goal-oriented intervention on functional goals and motor skills in infants aged 12 ± 3 months who are at risk of or have neuromotor dysfunction. Neuromotor dysfunction refers to impairments in motor control, coordination, and movement resulting from disturbances in the developing nervous system. During infancy, the brain demonstrates high neural plasticity, making early identification and intervention crucial for improving motor outcomes and preventing long-term functional limitations.

The study emphasizes a goal-directed, family-centered therapy approach, where meaningful and personalized functional goals are identified collaboratively with caregivers. Functional goals are prioritized because they directly relate to daily activities and promote active participation. Infants are screened using the Hammersmith Infant Neurological Examination (HINE) to ensure accurate identification of those at risk. Motor development and progress are assessed using the Peabody Developmental Motor Scales-2 (PDMS-2), while individualized functional achievement is measured through the Goal Attainment Scale (GAS).

A pre–post quasi-experimental design will be conducted at a high-risk baby clinic in a tertiary care hospital. Twenty-one eligible infants will be recruited through consecutive sampling. After baseline GAS and PDMS-2 assessments, each infant will receive a four-week individualized goal-directed therapy program. Caregivers will perform daily home-based sessions, supported by therapist guidance through tele-rehabilitation twice weekly. The intervention follows structured steps including goal setting, task analysis, strategy planning, skill practice, feedback, and re-evaluation.

Post-intervention assessments will compare changes in motor skills and functional goal achievement. Statistical analysis will determine the effectiveness of the intervention. The study aims to demonstrate that early, structured, goal-oriented therapy combined with caregiver involvement can significantly enhance motor development and functional independence in infants at risk of neuromotor dysfunction, thereby supporting better long-term developmental outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
11.00 Month(s) 至 13.00 Month(s)(—)
性别
All

入选标准

  • • Infants of age 12 months (corrected age).
  • • Both males and females are included.
  • • Infant at risk of Neuromotor dysfunction: Infant screened with mild , moderate and severe The Hammersmith Infant Neurological Examination (HINE) scores Corrected Age High-Risk Cut-off Score • Written informed consent is obtained from the parent or legal guardian prior to participation.

排除标准

  • • Infants diagnosed with visual or auditory impairments that limit their ability to follow instructions or participate in motor assessments.
  • • Infants who were receiving any physiotherapy intervention from past few weeks.
  • • Parents of participants not willing to participate in the study.

研究者

发起方
KAHER INSTITUTE OF PHYSIOTHERAPY
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Deepa Metgud

KAHER INSTITUTE OF PHYSIOTHERAPY

研究点 (1)

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