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Completed

NCT Number: NCT06560281

Improving Hand Movements in Kids With One-Sided Arm Stiffness Cerebral Palsy Through Motion Minder Therapy (MoMT)

Motion Minder Therapy 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, Motion Minder Therapy optimizes resources by utilizing smartwatches for a focused 1-hour intervention. The study employs a Pilot phase with 5 children. Materials range from smart watch to sensory tools, offering a comprehensive approach. Statistical analysis, incorporating repeated measure ANOVA, aims to underscore Motion Minder Therapy's effectiveness in addressing the complex challenges of fine motor skill enhancement in spastic hemiplegic cerebral palsy.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saveetha Medical College and Hospital, Chennai, Tamil Nadu, India

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About this study

Beginning with a 5-minute Sticker Sorting exercise, the intervention aims to improve fine motor skills, hand-eye coordination, and cognitive abilities via the use of colorful stickers with varying sizes and textures. Children can then go on to the next activity during a quick 1-minute Rest & Reflection phase. In the eight-minute segment Beads on Parade, participants practice bilateral hand usage, fine motor coordination, and visual-motor integration by stringing colorful beads onto threads or wires. Pegboard Activities, an 8-minute exercise that emphasizes accuracy, hand strength, and spatial awareness through the positioning of pegs onto a board with corresponding holes, is preceded by another brief reflective pause. The following five-minute Sensory Bins practice promotes tactile exploration with objects like beans or rice, developing tactile sensitivity and sensory awareness. An eight-minute session called "Sculpture Building" focuses on developing hand strength, coordination, creativity, and fine motor abilities via the creation of three-dimensional shapes using clay. A 5-minute break is followed by Finger Painting & Drawing with Different Tools, an activity that uses a variety of painting tools to improve hand control and fine motor skills. The last part, a five-minute musical instrument play, comes after the last period of relaxation. Through tactile and aural experiences, children are encouraged to use hand to make various sounds and rhythms, encouraging bilateral coordination, fine motor control, and sensory integration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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: Individuals with Mini-Mental Examination score of 15.
  • 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 metacarpophalangeal joints in the affected hand.

Exclusion criteria

  • 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.

Treatment and study plan

Motion Minder Therapy (MoMT)

Other

Motion Minder Therapy (MoMT) total duration is 1 hour a day, 5 days a week for 4 weeks. The treatment is a carefully planned sequence of exercises intended to help children with spastic hemiplegic cerebral palsy develop their fine motor abilities. Activities includes Sticker Sorting, Beads on Parade, Pegboard Activities, Sensory Bins, Sculpture Building, Finger Painting & Drawing with Different Tools, Musical Instrument Play. Smartwatches that have tactile sensations and auditory indications are used strategically during certain tasks to enhance proprioception and give real-time feedback, making the rehabilitation process vibrant and interesting.

Primary outcomes

  1. Shriners Hospital Upper Extremity Evaluation (SHUEE)

    Time frame: Baseline, 4th week, 8th week, 12th week

    The Shriners Hospital Upper Extremity Evaluation is a video-based tool for the assessment of upper extremity function. The outcome is the total score of the spontaneous functional analysis, dynamic positional analysis, and grasp/release analysis. Total scores of 45 for spontaneous functional analysis, 72 for dynamic positional analysis and 6 for grasp/release. Higher scores mean a better outcome.

  2. Nine Hole Peg Test

    Time frame: Baseline, 4th week, 8th week, 12th week

    Nine Hole Peg Test is used to measure the dexterity. Scores on nine-hole peg test are measured in seconds, indicating time taken to complete task. Higher scores indicate worse outcome, as they show slower completion times and reduced dexterity.

Secondary outcomes

  1. Strengths and difficulties questionnaire

    Time frame: Baseline, 4th week, 8th week, 12th week

    The 25 item Strengths and Difficulties Questionnaire (SDQ) measures behavioral and emotional function. These 25 items are divided into 5 subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. The Strengths and Difficulties Questionnaire is scored on a 3-point Likert-type scale, with total scores (excluding the prosocial scale) ranging from 0 to 40. Higher scores reflect greater behavioral and emotional difficulties.

Sponsors and collaborators

Lead sponsor

Saveetha University

Other

Registry information

Official study title

Effectiveness of Motion Minder Therapy (MoMT) Among Children With Spastic Hemiplegic Cerebral Palsy: A Pilot Study

Acronym: MoMT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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