NCT06560281

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2024

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

August 13, 2024

Last Update Submit

December 18, 2024

Conditions

Keywords

Cerebral PalsySpasticHemiplegic

Outcome Measures

Primary Outcomes (2)

  • Shriners Hospital Upper Extremity Evaluation (SHUEE)

    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

    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 Outcomes (1)

  • Strengths and difficulties questionnaire

    Baseline, 4th week, 8th week, 12th week

Study Arms (1)

Motion Minder Group

EXPERIMENTAL

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.

Other: Motion Minder Therapy (MoMT)

Interventions

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.

Motion Minder Group

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saveetha Medical College and Hospital

Chennai, Tamil Nadu, 602117, India

Location

Aadhuraa Special School

Kanchipuram, Tamil Nadu, 631501, India

Location

Related Publications (4)

  • 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.

    PMID: 25377769BACKGROUND
  • 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.

    PMID: 30279705BACKGROUND
  • 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.

    PMID: 17979861BACKGROUND
  • 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.

    PMID: 22801471BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Prathap Suganthirababu, Ph.D.,

    Saveetha University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 19, 2024

Study Start

January 22, 2024

Primary Completion

September 16, 2024

Study Completion

October 28, 2024

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations