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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06639802
Enrollment
23
Registered
2024-10-15
Start date
2024-04-10
Completion date
2024-12-01
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERHand 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.

Sponsors

Foundation University Islamabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Balance2 weeksA 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).
Coordination2 weeksMethod 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.

Countries

Pakistan

Contacts

Primary ContactAmina Aqil, MS-NPT
aminaaqil11@gmail.com+923330418548

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026