Cerebral Palsy Spastic HemiplegicMoMTNCT06560281
Improving Hand Movements in Kids With One-Sided Arm Stiffness Cerebral Palsy Through Motion Minder Therapy (MoMT)
A study testing Motion Minder Therapy (MoMT) in people with Cerebral Palsy Spastic Hemiplegic, run by Saveetha University at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy Spastic Hemiplegic
- What is being tested?
- Motion Minder Therapy (MoMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesIndia
- Study dates
- 22 Jan 2024to 28 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Saveetha Medical College and Hospital
Chennai, Tamil Nadu, 602117
Aadhuraa Special School
Kanchipuram, Tamil Nadu, 631501
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy Spastic Hemiplegic
- Being tested
- Motion Minder Therapy (MoMT)
- Keywords
- Cerebral Palsy, Spastic, Hemiplegic
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Motion Minder Therapy (MoMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 4th week, 8th week, 12th week
Secondary outcomes (1)
Strengths and difficulties questionnaire
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.
Measured: Baseline, 4th week, 8th week, 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start22 Jan 2024
- Primary completion16 Sep 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy Spastic HemiplegicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saveetha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeevarathinam Thirumalai, Saveetha University
- Investigators
- Prathap Suganthirababu, Ph.D.,, Study chair, Saveetha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560281
- Sponsor's protocol ID
- 12/032/2024/ISRB/SR/SCPT
- Acronym
- MoMT
- Status last verified
- Dec 2024
- First submitted
- 13 Aug 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25377769Jamali 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.
PubMed 30279705Gordon 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.
PubMed 17979861Fong 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.
PubMed 22801471
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Motion Minder Therapy (MoMT) Among Children With Spastic Hemiplegic Cerebral Palsy: A Pilot Study
- ClinicalTrials.gov ID
- NCT06560281
- Acronym / sponsor ID
- MoMT / 12/032/2024/ISRB/SR/SCPT
- Conditions
- Cerebral Palsy Spastic Hemiplegic
- Keywords
- Cerebral Palsy, Spastic, Hemiplegic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Saveetha UniversityUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motion Minder Group | Experimental | Other: Motion Minder Therapy (MoMT)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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Motion Minder Group |
Primary outcome
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.
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.
1 secondary outcome
Strengths and difficulties questionnaire
Time frame: Baseline, 4th week, 8th week, 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Background: PubMed 25377769Finn 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.
- Background: PubMed 30279705Jamali 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.
- Background: PubMed 17979861Gordon 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.
- Background: PubMed 22801471Fong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prathap Suganthirababu, Ph.D., study chair
Saveetha University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion Minder Therapy (MoMT) in people with Cerebral Palsy Spastic Hemiplegic, run by Saveetha University at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shriners Hospital Upper Extremity Evaluation (SHUEE) (time frame: Baseline, 4th week, 8th week, 12th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06560281, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.