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

NCT ID: NCT06639802

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-10
• Study Completion Date: 2024-12-01

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.

Conditions

Ataxic Cerebral Palsy; Coordination and Balance Disturbances

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

HABIT-ILE is continuous intervention applied for 50-90 hours over two weeks. We will design the activities based on the findings of the initial assessments (T0) T0he customized functional goals that were previously discussed with the parents (e.g., drinking on one's own without spilling, using one hand to hold a book while turning pages with the other, removing a t-shirt, etc.).

The whole environment is arranged in such a way that children perceive the therapy as fun.

Progression of difficulty depend upon success in performance of current level. Specific bi-manual activities are selected on basis of child's motor abilities, age and interest.

Group Type: EXPERIMENTAL

Hand Arm Bimanual Intensive therapy including lower extremity (HABIT-ILE)

Intervention Type: OTHER

HABIT-ILE is continuous intervention applied for 50-90 hours over two weeks. We will design the activities based on the findings of the initial assessments (T0) and the customized functional goals that were previously discussed with the parents (e.g., drinking on one\'s own without spilling, using one hand to hold a book while turning pages with the other, removing a t-shirt, etc.). HABIT-ILE activities are presented as games and the whole environment is arranged in such a way that children perceive the therapy as fun. Progression of difficulty depend upon success in performance of current level. Specific bi-manual activities are selected on basis of child's motor abilities, age and interest.

Interventions

Hand Arm Bimanual Intensive therapy including lower extremity (HABIT-ILE)

HABIT-ILE is continuous intervention applied for 50-90 hours over two weeks. We will design the activities based on the findings of the initial assessments (T0) and the customized functional goals that were previously discussed with the parents (e.g., drinking on one\'s own without spilling, using one hand to hold a book while turning pages with the other, removing a t-shirt, etc.). HABIT-ILE activities are presented as games and the whole environment is arranged in such a way that children perceive the therapy as fun. Progression of difficulty depend upon success in performance of current level. Specific bi-manual activities are selected on basis of child's motor abilities, age and interest.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Foundation University College of Physical Therapy

Rawalpindi, , Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Amina Aqil, MS-NPT

Role: CONTACT

aminaaqil11@gmail.com

+923330418548

Facility Contacts

Furqan Ahmed Siddiqi, PhD in Rehabilitation Sciences

Role: primary

principal.fucp@fui.edu.pk

+923004414981

Other Identifiers

FUI/CTR/2024/31

Identifier Type: -

Identifier Source: org_study_id