| CTRI Number |
CTRI/2024/05/066622 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the Impact of Task-Oriented Training Rooted in Neurodevelopmental Therapy Principles on Gait and Daily Functional Activities in Cerebral Palsy |
|
Scientific Title of Study
|
Effect of Task-oriented training based on neurodevelopment therapy principle on gait and functional activities of daily living in cerebral palsy
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Narendra Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias university |
| Address |
B Block Room ,no-B 319 Department of Physiotherapy Plot No.2,Galgotias university, Yamuna expy, opposite Buddha international circuit, Sector 17A,Greaternoida utter padresh India
B Block Room ,no-B 319 Department of Physiotherapy Plot No.2,Galgotias university, Yamuna expy, opposite Buddha international circuit, Sector 17A,Greaternoida utter padresh India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8447757691 |
| Fax |
|
| Email |
narendrakumargims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sajjad Alam |
| Designation |
Professor |
| Affiliation |
Galgotias university |
| Address |
B Block Room ,no-B 319 Department of Physiotherapy Plot No.2,Galgotias university, Yamuna expy, opposite Buddha international circuit, Sector 17A,Greaternoida utter pradesh India
B Block Room ,no-B 319 Department of Physiotherapy Plot No.2,Galgotias university, Yamuna expy, opposite Buddha international circuit, Sector 17A,Greaternoida utter pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9818879898 |
| Fax |
|
| Email |
sajjad.alam@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Narendra Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias university |
| Address |
B Block Room ,no-B 319 Department of Physiotherapy Plot No.2,Galgotias university, Yamuna expy, opposite Buddha international circuit, Sector 17A,Greaternoida utter pradesh India
B Block Room ,no-B 319 Department of Physiotherapy Plot No.2,Galgotias university, Yamuna expy, opposite Buddha international circuit, Sector 17A,Greaternoida utter pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8447757691 |
| Fax |
|
| Email |
narendrakumargims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell Galgotias University Plot No. 2, Yamuna Expy, opposite
Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
B Block Room ,no-B 319 Department of Physiotherapy Plot No.2,Galgotias university, Yamuna expy, opposite Buddha international circuit, Sector 17A,Greaternoida utter pradesh India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Narendra Kumar |
School Of Allied Health Sciences Galgotias University |
B 512 Galgotias University Plot No. 2, Yamuna Expy, opposite
Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
8447767591
narendrakumargims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Training |
Warm up exercise,
Stretching exercise
|
| Intervention |
Task orientation Training |
Standing Exercise Walking exercise Balance training exercise |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age Range: Children and adolescents aged between 5 and 12 years.
Diagnosis: Participants must have a confirmed diagnosis of cerebral palsy by a qualified medical professional.
Type of Cerebral Palsy: Children and adolescents with any type of cerebral palsy (spastic, dyskinetic, ataxic, or mixed) are eligible for inclusion.
Gait Impairment: Individuals should exhibit gait abnormalities, such as altered stride length, step width, or gait velocity, that affect their functional mobility.
Ability to Walk: Participants must be capable of walking independently or with the use of assistive devices, such as walkers or crutches. Medical Stability: Individuals should be medically stable and free from any acute medical conditions that could interfere with participation in the training program.
Ability to Follow Instructions: Participants should have the cognitive and communicative ability to understand and comply with the instructions during the training sessions.
|
|
| ExclusionCriteria |
| Details |
Severe Cognitive Impairment: Participants with severe cognitive impairments or intellectual disabilities that would hinder their ability to actively participate in the task-oriented training program will be excluded.
Severe Communication Difficulties: Individuals with significant communication difficulties, making it challenging to understand or follow instructions during the training sessions, will be excluded.
Uncontrolled Medical Conditions: Participants with uncontrolled medical conditions, such as uncontrolled seizures or active infections, that could compromise their safety or interfere with the study outcomes will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Motion analysis tool (Gaiton) |
8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Functional Mobility Scale (FMS) |
8 week |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Cerebral palsy (CP) is a group of non-progressive motor disorders caused by damage to the developing brain, primarily affecting movement and posture(1). It is one of the most common physical disabilities affecting children worldwide, with a prevalence of approximately 2.11 per 1000 live births(2). Children with cerebral palsy often experience significant impairments in gait, leading to decreased functional independence and reduced quality of life. Gait abnormalities in CP can manifest as alterations in stride length, step width, velocity, and overall gait pattern(3,4). Cerebral palsy is a complex and heterogeneous neurological condition that affects movement and posture. It is caused by abnormal brain development or damage to the brain, occurring either during pregnancy, childbirth, or the early years of life(5). This non-progressive disorder manifests in various motor impairments, including muscle stiffness, involuntary movements, muscle weakness, and coordination difficulties. Individuals with cerebral palsy may also experience associated conditions, such as intellectual disabilities, epilepsy, communication challenges, and sensory impairments(6). The severity of the condition can vary significantly from person to person, with some individuals being mildly affected, while others may have more severe and profound impairments(7). The four main types of cerebral palsy are spastic, dyskinetic, ataxic, and mixed, each characterized by specific movement patterns and affected body parts. Spastic cerebral palsy, the most common type, is marked by increased muscle tone and stiffness, leading to limited joint movement and muscle control(8). Dyskinetic cerebral palsy involves uncontrollable and involuntary movements, affecting both gross and fine motor skills. Ataxic cerebral palsy results in problems with balance and coordination, leading to shaky movements and difficulty performing precise motor tasks. Mixed cerebral palsy is a combination of two or more types of movement disorders, resulting in a wide range of symptoms and challenges. The exact cause of cerebral palsy remains unclear in many cases, although several risk factors have been identified. These include premature birth, low birth weight, multiple pregnancies, maternal infections during pregnancy, and brain injuries from oxygen deprivation during childbirth. Early diagnosis and intervention are crucial for managing cerebral palsy effectively. Therapeutic approaches like physical therapy, occupational therapy, and speech therapy aim to improve mobility, motor skills, and communication abilities. Medications may also be prescribed to manage spasticity, alleviate pain, or control associated conditions like seizures. In more severe cases, surgical interventions might be necessary to address specific orthopaedic issues |