Effects of Hand Arm Bimanual Intensive Therapy Including Lower Extremity on Balance and Coordination in Ataxic Cerebral Palsy

Not Applicable

Recruiting

• Conditions: Ataxic Cerebral Palsy; Coordination and Balance Disturbances

• Registration Number: NCT06639802
• Lead Sponsor: Foundation University Islamabad

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.

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.

Study Timeline

• Study Start: 2024-04-10
• Study First Submitted: 2024-09-20
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Age group: 6 - 15 years.
• Gender: Both males and females.
• Cerebellar Ataxic cerebral palsy [10]
• Gross motor function classification system level I and II.
• Capable of following instructions and completing all necessary tests and tasks

Exclusion Criteria

• Uncontrolled epilepsy
• Orthopedic surgery within the past 6 months,
• Have visual, and hearing impairments (diagnosed).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Balance	2 weeks	A modified version of the Berg Balance Scale, the Pediatric Balance Scale is used to evaluate school-age children\'s functional balance abilities. The 14 items on the scale have a maximum score of 56 points and are rated from 0 (lowest function) to 4 (highest function).
Coordination	2 weeks	Method for evaluating ataxia is SARA, which consists of eight categories, each category is scored from 0 (no ataxia) to 40 (severe ataxia) based on the performance.

Trial Locations

Locations (1)

Foundation University College of Physical Therapy; 🇵🇰 Rawalpindi, Pakistan