- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07248566
Cognitive Sensory Motor Training Therapy for Children With Cerebral Palsy
Effects of Cognitive Sensory Motor Training Therapy on Dexterity and Upper Limb Function in Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy defined as a neuro-impairment with motor disability caused by a non- progressive defect or lesion of the immature brain. Cerebral palsy (CP) impact approximately
1 in 500 children worldwide, affecting motor function, muscle tone, and coordination.
Children with CP will experience limitations in daily activities, social participation, and quality of life due to impaired upper limb function. To address this, rehabilitation strategies will focus on enhancing dexterity, and upper limb function. The aims of the study is to examine the effects of cognitive sensory motor training therapy on dexterity and upper limb function in children with CP. The current study will be randomized controlled trial, data will be collected from Central Park Teaching Hospital. The study will include 32 participants equally divided into two groups and randomly allocated. Inclusion criteria for this study will be consist of diagnosis with cerebral palsy, age 6-12, ability to participate in cognitive sensory motor training therapy, stable medical condition, and informed consent from parents/guardians. Participants with severe cognitive impairments, unstable medical condition, history of spinal cord injury or deformity, diagnosis with other neurological conditions, and visual or hearing impairments will be excluded from the study.. The Experimental group will receive Cognitive Sensory Motor Training Therapy and Routine Physical Therapy, while the Control group will receive Routine Physical Therapy.Cognitive Sensory Motor Training Therapy (CSMT) for 35 minutes, five times a week, over 12 weeks. Data collection will be done before and after the interventions.Outcome measures will include the dexterity, and upper limb function.Tools used for data collection will be Action Research Arm Test and Box and Block Test. Data analysis will utilize SPSS version 25.00.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- Muhammad Asif Jvaed
-
Contact:
- Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 6-12 years with cerebral palsy
- Diagnosis confirmed by pediatric neurologist or rehabilitation specialist
- Ability to follow simple instructions and participate in therapy sessions.
- Participants had to be able to focus attention on demonstrate level II and III on the Gross
- Motor Function Classification Scale (GMFCS)
- Level II or III on the Manual Ability Classification System (MACS)
Exclusion Criteria:
- Visual impairment or hearing defect
- Severe cognitive decline and aphasia
- Contractures that could limit the patient from maintaining the extended arm in a comfortable position,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A
participated in Cognitive Sensory Motor Training Therapy (CSMT) for 35 minutes, five times a week, over 12 weeks. Cognitive exercise therapy combines spatial and tactile tasks to improve cognitive function, focusing on perception and sensory awareness. Participants completed 5 tasks, customized to their recovery progress |
Cognitive Sensory Motor Training Therapy (CSMT) for 35 minutes, five times a week, over 12 weeks. Cognitive exercise therapy combines spatial and tactile tasks to improve cognitive function, focusing on perception and sensory awareness. Participants completed 5 tasks, customized to their recovery progress. |
|
Active Comparator: Group B
participants received conventional occupational therapy, consisting of many purposeful kinetic activities such as skateboard-supported arm-sliding exercises on a tabletop, picking up a ball and putting it into a basket, bi-manual placing cone, shoulder curved arch, double curved arch, arm bicycling, donut on base, putty kneading, block stacking, peg board exercise, graded pinch exercise and plastic cone stacking.
Therapists could offer passive, active-assistive or active training, as deemed appropriate to the patient's ability
|
Participants received conventional occupational therapy, consisting of many purposeful kinetic activities such as skateboard-supported arm-sliding exercises on a tabletop, picking up a ball and putting it into a basket, bi-manual placing cone, shoulder curved arch, double curved arch, arm bicycling, donut on base, putty kneading, block stacking, peg board exercise, graded pinch exercise and plastic cone stacking.
Therapists could offer passive, active-assistive or active training, as deemed appropriate to the patient's ability
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Action Research Arm Test:
Time Frame: The test can be completed in an average of 10 minutes but requires specific materials
|
The ARAT is a standardized measure of the upper extremity (arm and hand) function based on four movements : grasping, grip-ping, pinching and gross movements of shoulder,elbow and fingers. ARAT has an ordinal 4-point scale (0-3) for 19 items. Scoring is determined as follows: 0, patient cannot perform any part of task;1, patient is able to lift the object completely from the platform; 2, function is performed fully but clumsily or with great difficulty; and 3, the movement is performed normally. The maximum score for each arm is 57 points. |
The test can be completed in an average of 10 minutes but requires specific materials
|
|
Box and Block Test:
Time Frame: The number moved in 60 seconds is the recorded score.
|
The box and block test 13 will be used to evaluate gross manual dexterity.
The setup consists of two adjacent boxes of the same size (53.7 × 25.4 × 8.5cm), one of them filled with 150 blocks (2.5 cm 3).Between the two boxes, there is a partition 15.2 cm in height.
The patient must move blocks one by one from one box to the other, over the partition.
|
The number moved in 60 seconds is the recorded score.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sadia Javed, MS-PT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/SADIAJAVED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cerebral Palsy
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesRecruiting
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecruitingCerebral Palsy (CP) | Hemiplegic Cerebral PalsyCanada
-
Cairo UniversityCompletedCerebral Palsy (CP) | Unilateral Cerebral PalsyEgypt
-
University of California, San FranciscoNot yet recruitingCerebral Palsy | Cerebral Palsy (CP) | Infant | Cerebral Palsy InfantileUnited States
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
IRCCS Fondazione Stella MarisNot yet recruitingCerebral Palsy (CP) | EEG | Unilateral Cerebral Palsy | Action ObservationItaly
-
IRCCS Fondazione Stella MarisUniversity of Siena, ItalyRecruitingCerebral Palsy (CP) | Motor Imagery | CP (Cerebral Palsy) | Action ObservationItaly
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
Clinical Trials on Cognitive Sensory Motor Training Therapy
-
Prasat Neurological InstituteMahidol UniversityCompleted
-
Riphah International UniversityCompleted
-
University Hospital TuebingenParkinson StiftungNot yet recruitingMild Cognitive Impairment (MCI) | PARKINSON DISEASE (Disorder)Germany
-
University Ramon LlullAinhoa Nieto Guisado; Mònica Solana-TramuntUnknownCognitive Change | Proprioception Change | Balance ChangeSpain
-
Foundation University IslamabadCompletedBalance | Cognitive FunctionsPakistan
-
University of California, San DiegoCompletedAutism Spectrum Disorder | Autistic DisorderUnited States
-
Shaimaa Mohamed Ahmed ElsayehActive, not recruitingBurn | Postural StabilityEgypt
-
Riphah International UniversityCompletedParkinson Disease | Postural; Defect | Balance; DistortedPakistan
-
University of PlymouthRecruiting
-
Riphah International UniversityCompletedKnee OsteoarthritisPakistan