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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 602117
        • Saveetha Medical College and Hospital
      • Kānchipuram, Tamil Nadu, India, 631501
        • Aadhuraa Special School

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Motion Minder Therapy (MoMT)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saveetha University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Drug Interventions

Conditions

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Drug Interventions

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