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

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.

Study Overview

• Status: Recruiting
• Conditions: Coordination and Balance Disturbances; Ataxic Cerebral Palsy
• Intervention / Treatment: Other: Hand Arm Bimanual Intensive therapy including lower extremity (HABIT-ILE)

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 Type: Interventional
• Enrollment (Estimated): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amina Aqil, MS-NPT; Phone Number: +923330418548; Email: aminaaqil11@gmail.com

Study Locations

• Pakistan
  • Rawalpindi, Pakistan, 46000
    • Recruiting
    • Foundation University College of Physical Therapy
    • Contact: FURQAN Ahmed Siddiqi, PhD in Rehabilitation Sciences; Phone Number: +923004414981; Email: principal.fucp@fui.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance	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).	2 weeks
Coordination	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.	2 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Physical Therapy Technique; coordination impairement; Ataxic Cerebral Palsy; HAnd Arm Bimanual Intensive Therapy including Lower Extremity
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Dyskinesias; Cerebral Palsy; Paralysis; Ataxia; Genetic Diseases, Inborn
• Other Study ID Numbers: FUI/CTR/2024/31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No