- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06560281
Improving Hand Movements in Kids With One-Sided Arm Stiffness Cerebral Palsy Through Motion Minder Therapy (MoMT) (MoMT)
December 18, 2024 updated by: Jeevarathinam Thirumalai, Saveetha University
Effectiveness of Motion Minder Therapy (MoMT) Among Children With Spastic Hemiplegic Cerebral Palsy: A Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tamil Nadu
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Chennai, Tamil Nadu, India, 602117
- Saveetha Medical College and hospital
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Kānchipuram, Tamil Nadu, India, 631501
- Aadhuraa Special School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motion Minder Group
Children in this arm receives a structured motion minder therapy protocol designed to improve fine motor skills in children with spastic hemiplegic cerebral palsy through targeted activities.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 4th week, 8th week, 12th week
|
|
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.
|
Baseline, 4th week, 8th week, 12th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 4th week, 8th week, 12th week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Prathap Suganthirababu, Ph.D.,, Saveetha University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. doi: 10.1111/j.1469-8749.2007.00830.x.
- Jamali AR, Amini M. The Effects of Constraint-Induced Movement Therapy on Functions of Cerebral Palsy Children. Iran J Child Neurol. 2018 Fall;12(4):16-27.
- Finn L, Ramasamy R, Dukes C, Scott J. Using WatchMinder to Increase the On-Task Behavior of Students with Autism Spectrum Disorder. J Autism Dev Disord. 2015 May;45(5):1408-18. doi: 10.1007/s10803-014-2300-x.
- Fong KN, Jim ES, Dong VA, Cheung HK. 'Remind to move': a pilot study on the effects of sensory cueing treatment on hemiplegic upper limb functions in children with unilateral cerebral palsy. Clin Rehabil. 2013 Jan;27(1):82-9. doi: 10.1177/0269215512448199. Epub 2012 Jul 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 22, 2024
Primary Completion (Actual)
September 16, 2024
Study Completion (Actual)
October 28, 2024
Study Registration Dates
First Submitted
August 13, 2024
First Submitted That Met QC Criteria
August 15, 2024
First Posted (Actual)
August 19, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 18, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12/032/2024/ISRB/SR/SCPT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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