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

NCT06639802 | Recruiting

• 1 other identifier: FUI/CTR/2024/31
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Experimental group

EXPERIMENTAL

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)

Interventions

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

Experimental group

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy, Ataxic, Autosomal Recessive

Central Study Contacts

Amina Aqil, MS-NPT

CONTACT

+923330418548; aminaaqil11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 15, 2024
• Study Start: April 10, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)