| CTRI Number |
CTRI/2024/01/061490 [Registered on: 15/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Hand Movements in Kids with One-Sided Arm Stiffness Cerebral Palsy through Motion Minder Therapy (MoMT) |
|
Scientific Title of Study
|
Effectiveness of Motion Minder Therapy (MoMT) on Fine Motor Skills Among Children with Spastic Hemiplegia |
| Trial Acronym |
MoMT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeevarathinam Thirumalai |
| Designation |
Student |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
Saveetha College of Physiotherapy, AHS 4th floor,
Saveetha Institute of Medical and Technical Sciences,
Thandalam.
Chennai
TAMIL NADU
602105
India |
| Phone |
6384577805 |
| Fax |
|
| Email |
jeevarathinamhope@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Vinodhkumar Ramalingam |
| Designation |
Professor |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
Saveetha College of Physiotherapy, AHS 5th floor, Room No: A5, Sports Physiotherapy Department, Saveetha Institute of Medical and Technical Sciences,
Thandalam.
Chennai
TAMIL NADU
602105
India |
| Phone |
8760563032 |
| Fax |
|
| Email |
vinodhkumar.scpt@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Jagatheesan Alagesan |
| Designation |
Professor and Principal |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
Saveetha College of Physiotherapy, AHS 4th floor,Paediatric Physiotherapy Department,
Saveetha Institute of Medical and Technical Sciences,
Thandalam.
Chennai
TAMIL NADU
602105
India |
| Phone |
9500200345 |
| Fax |
|
| Email |
jagatheesanphd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
|
|
Primary Sponsor
|
| Name |
Jeevarathinam Thirumalai |
| Address |
Saveetha College of Physiotherapy,
Saveetha Institute of Medical and Technical Sciences,
Thandalam,
Chennai. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Subha R |
Aadhuraa Special School |
Department of Physiotherapy, Ground Floor, Physiotherapy Unit, Murugammal Nagar, Velingapattarai, Orikkai, Kanchipuram - 631502.
Kancheepuram
TAMIL NADU |
8220018518
aadhuraa@gmail.com |
| Prof Dr Vinodhkumar Ramalingam |
Saveetha Medical College and Hospital |
Department of Physiotherapy, 1st Floor, Paediatric Physiotherapy Unit,
Thandalam,
Chennai 602 105.
Chennai
TAMIL NADU |
8760563032
vinodhkumar.scpt@saveetha.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL SCIENTIFIC REVIEW BOARD |
Approved |
| INSTITUTIONAL SCIENTIFIC REVIEW BOARD |
Approved |
| INSTITUTIONAL SCIENTIFIC REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hand Arm Bimanual Intensive Therapy (HABIT) |
1 hour a day, 5 days a week, for 4 weeks is the total duration of the traditional intervention, Hand Arm Bimanual Intensive Therapy (HABIT). Activities in the programme that target improving fine motor skills include dough, ball and cube, bottle and marble, stringing beads, and manipulation exercises. Enhancing fine motor skills and hand-eye coordination is the main focus of this systematic technique. |
| Intervention |
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. 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 colourful 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 practise bilateral hand usage, fine motor coordination, and visual-motor integration by stringing colourful beads onto threads or wires. Pegboard Activities, an 8-minute exercise that emphasises 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. An 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. 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. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
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 (MMC): Individuals with MMC 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 MCP joints in the affected hand.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Shriners Hospital Upper Extremity Evaluation (SHUEE), Nine Hole Peg Test |
Following the baseline pre-test assessment, a post-test assessment will be conducted after 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ABILHAND-KIDS questionnaire |
Baseline pre-test assessment continued by after 4 weeks of post-test assessment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "19"
Final Enrollment numbers achieved (India)="19" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/01/2024 |
| Date of Study Completion (India) |
09/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Motion Minder Therapy (MoMT) 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 , MoMT optimizes resources by utilizing smartwatches for a focused 1-hour intervention. The study employs a Pilot (Phase I) with 5 children and an Experimental (Phase II) design with 20 participants, comparing MoMT with Hand-Arm Bimanual Intensive Therapy. Materials range from smart watch to sensory tools, offering a comprehensive approach. Primary and secondary outcomes, assessed through the Assisting Hand Assessment and ABILHAND Kids questionnaire, contribute to a thorough evaluation. Statistical analysis, incorporating inferential and descriptive statistics with a paired t-test, aims to underscore MoMT’s effectiveness in addressing the complex challenges of fine motor skill enhancement in spastic hemiplegic cerebral palsy.
|