Clinical trial NCT06639802: Effects of Hand Arm Bimanual Intensive Therapy Including Lower Extremity on Balance and Coordination in Ataxic Cerebral Palsy
Official title: Effects of Hand Arm Bimanual Intensive Therapy Including Lower Extremity on Balance and Coordination in Ataxic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ataxic Cerebral Palsy
Coordination and Balance Disturbances
Keywords: Physical Therapy Technique
coordination impairement
Ataxic Cerebral Palsy
HAnd Arm Bimanual Intensive Therapy including Lower Extremity
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 23
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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\&gt;0.05)

Null Hypothesis:

There will be no statistically significant differences in balance and cooordination after HABIT-ILE in ataxic cerebral palsy.(P\&gt;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 \&amp; Revised (GMFCS - E\&amp;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.

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).

Primary outcomes:
measure: Balance
timeFrame: 2 weeks
measure: Coordination
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
Study officials:
References: