Clinical trial NCT06560281: Improving Hand Movements in Kids With One-Sided Arm Stiffness Cerebral Palsy Through Motion Minder Therapy (MoMT)
Official title: Effectiveness of Motion Minder Therapy (MoMT) Among Children With Spastic Hemiplegic Cerebral Palsy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy Spastic Hemiplegic
Keywords: Cerebral Palsy
Spastic
Hemiplegic
Lead sponsor: Saveetha University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Shriners Hospital Upper Extremity Evaluation (SHUEE)
timeFrame: Baseline, 4th week, 8th week, 12th week
measure: Nine Hole Peg Test
timeFrame: Baseline, 4th week, 8th week, 12th week
Secondary outcomes:
measure: Strengths and difficulties questionnaire
timeFrame: Baseline, 4th week, 8th week, 12th week
Other outcomes:
Locations:
city: Chennai
country: India
facility: Saveetha Medical College and Hospital
state: Tamil Nadu
city: Kānchipuram
country: India
facility: Aadhuraa Special School
state: Tamil Nadu
Study officials:
affiliation: Saveetha University
name: Prathap Suganthirababu, Ph.D.,
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.