Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-04 @ 12:24 PM
Study NCT ID:
NCT06639802
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Hand Arm Bimanual Intensive Therapy Including Lower Extremity on Balance and Coordination in Ataxic Cerebral Palsy
Sponsor:
Foundation University Islamabad
Organization:
Study Overview
Official Title:
Effects of Hand Arm Bimanual Intensive Therapy Including Lower Extremity on Balance and Coordination in Ataxic Cerebral Palsy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ataxic cerebral palsy is an abnormal movement or posture pattern accompanied by a loss of coordinated muscle action, resulting in movements that lack proper force, rhythm, or accuracy. Ataxic CP is classified into cerebellar ataxia and ataxic diplegia.
In Cerebellar Ataxia, the cerebellum is hypo-plastic or malformed which impairs the integration of brain signals required for coordinating coordinated movement and balance. This study aimed to determine the effect of HABIT-ILE on the balance and coordination of children with cerebellar ataxic cerebral palsy.
In Cerebellar Ataxia, the cerebellum is hypo-plastic or malformed which impairs the integration of brain signals required for coordinating coordinated movement and balance. This study aimed to determine the effect of HABIT-ILE on the balance and coordination of children with cerebellar ataxic cerebral palsy.
Detailed Description:
OBJECTIVES:
The objectives of this study are:
1. To determine the effect of HABIT-ILE on the coordination of children with cerebellar ataxic cerebral palsy.
2. To determine the effect of HABIT-ILE on the balance of children with cerebellar ataxic cerebral palsy.
HYPOTHESIS:
Alternate Hypothesis:
There will be statistically significant differences in balance and coordination after HABIT-ILE in ataxic cerebral palsy.(P\>0.05)
Null Hypothesis:
There will be no statistically significant differences in balance and cooordination after HABIT-ILE in ataxic cerebral palsy.(P\>0.05)
Research Design: Experimental study. Quasi-experimental
Clinical setting: Al-Farabi Special Education Institute Islamabad Study duration: one year from Feb 2024 to 2025.
Selection Criteria:
Inclusion Criteria
1. Age group: 6 - 15 years.
2. Gender: Both males and females.
3. Cerebellar Ataxic cerebral palsy \[1\]
4. Gross motor function classification system level I and II.
5. Capable of following instructions and completing all necessary tests and tasks
Exclusion Criteria
1. Uncontrolled epilepsy
2. Orthopedic surgery within the past 6 months,
3. Have visual, hearing impairments (diagnosed).
Sampling technique: convenicence sampling
Outcome Measures:
1. Pediatric Balance Scale \[2\]
2. Scale for the Assessment and Rating of Ataxia \[3\]
3. Gross Motor Function Classification System - Expanded \& Revised (GMFCS - E\&R) \[4\]
Data analysis techniques:
Data will be analyzed using SPSS version 20.0.0.
Significance of the study:
Cerebellar ataxic cerebral palsy is characterized by hypoplasia or malformations of the cerebellum, which hinders the integration of neural information necessary for coordination and balance.
HABIT-ILE aims to collectively target the whole body both upper and lower extremity along with trunk in intensive therapy comprising of fun and playful goal oriented tasks in order to improve balance and coordination.
So this research will find out effects of HABIT-ILE on balance and coordination of children with cerebellar ataxic cerebral palsy. Positive research outcome can contribute to better independence.
This study will add data in the limited literature of ataxic cerebral palsy.
The objectives of this study are:
1. To determine the effect of HABIT-ILE on the coordination of children with cerebellar ataxic cerebral palsy.
2. To determine the effect of HABIT-ILE on the balance of children with cerebellar ataxic cerebral palsy.
HYPOTHESIS:
Alternate Hypothesis:
There will be statistically significant differences in balance and coordination after HABIT-ILE in ataxic cerebral palsy.(P\>0.05)
Null Hypothesis:
There will be no statistically significant differences in balance and cooordination after HABIT-ILE in ataxic cerebral palsy.(P\>0.05)
Research Design: Experimental study. Quasi-experimental
Clinical setting: Al-Farabi Special Education Institute Islamabad Study duration: one year from Feb 2024 to 2025.
Selection Criteria:
Inclusion Criteria
1. Age group: 6 - 15 years.
2. Gender: Both males and females.
3. Cerebellar Ataxic cerebral palsy \[1\]
4. Gross motor function classification system level I and II.
5. Capable of following instructions and completing all necessary tests and tasks
Exclusion Criteria
1. Uncontrolled epilepsy
2. Orthopedic surgery within the past 6 months,
3. Have visual, hearing impairments (diagnosed).
Sampling technique: convenicence sampling
Outcome Measures:
1. Pediatric Balance Scale \[2\]
2. Scale for the Assessment and Rating of Ataxia \[3\]
3. Gross Motor Function Classification System - Expanded \& Revised (GMFCS - E\&R) \[4\]
Data analysis techniques:
Data will be analyzed using SPSS version 20.0.0.
Significance of the study:
Cerebellar ataxic cerebral palsy is characterized by hypoplasia or malformations of the cerebellum, which hinders the integration of neural information necessary for coordination and balance.
HABIT-ILE aims to collectively target the whole body both upper and lower extremity along with trunk in intensive therapy comprising of fun and playful goal oriented tasks in order to improve balance and coordination.
So this research will find out effects of HABIT-ILE on balance and coordination of children with cerebellar ataxic cerebral palsy. Positive research outcome can contribute to better independence.
This study will add data in the limited literature of ataxic cerebral palsy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: