Action Observation Training for Functional Performance in Children with Cerebral Palsy

This study is a randomized control trial and aims to determine the effects of Action Observation on balance and mobility in patients with cerebral palsy compared to training without action observation.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy (CP); Physical Functional Performance
• Intervention / Treatment: Procedure: Training with Action Observation Therapy; Procedure: Training without Action Observation Therapy

Detailed Description

Effetcs of Action observation will be assessed for functional performance which includes the parameters of balance and mobility.

Spastic CP children agd 5-12 will be recruited in the study. The participants would be assessed through Modified Ashworth scale, GMFCS, Pediatrics balance scale and GMFM-88 .

Informed Consent will ne taken after which the participants will be recruited into the two groups, where one group will recieve training with Action observation and other group will receive training without Action observation.

Baseline and Post-treatment measurements will be taken for analysis.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayesha Inam, DPT; Phone Number: +92332-5217887; Email: ayesharwp@gmail.com

Study Locations

• Pakistan
  • Islamabad, Pakistan, 44000
    • Recruiting
    • Foundation University College of Physical Thrapy
    • Contact: Furqan Ahmed Siddiqi, Phd; Phone Number: 602 051-5788171; Email: principal.fucp@fui.edu.pk

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age 5-12.
• Spastic CP.
• Modified Ashworth Scale spasticity score 0-2
• GMFCS level I, II or III.
• Able to understand and follow commands, e.g. "Stand up, please".
• Able to sit to stand with or without assistance.

Exclusion Criteria:

• Any orthopedic procedure in the past 6 months, that could prevent exercise training.
• Any co-morbid condition such as spinal atrophy, osteogenesis imperfecta etc.
• History of chronic seizure attacks.
• Children with severe visual/hearing impairments.
• Presence of knee contractures

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Group; The participants will receive AOT based mobility and balance exercises along with conventional therapy consisting of simple lower limb stretchings and strengthening . The AOT-based exercises include different exercises in sitting, standing and turning stances. The fun based activities inlcude reaching for objects, tower building and taking turns in various stances.	Procedure: Training with Action Observation Therapy; AOT based mobility and balance exercises along with conventional therapy consisting of simple lower limb stretchings and strengthening. The fun based activities inlcude reaching for objects, tower building and taking turns in various stances.
Active Comparator: Control Group; The participants will receive mobility and balance exercises without Action Obseravtion along with conventional therapy consisting of simple lower limb stretchings and strengthening . The AOT-based exercises include different exercises in sitting, standing and turning stances. The fun based activities inlcude reaching for objects, tower building and taking turns in various stances.	Procedure: Training without Action Observation Therapy; Cerebral Palsy patients will receive balance and mobility training without action observation in various stances of sitting, standing and turning. Activities are fun based and include reaching for objects, tower building and taking turns in different positions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static balance	Pediatrics berg balance scale will be used for balance assessment. It has a total score of 56, with higher scores indicating better balance.	8 weeks
Dynamic balance	Pediatrics berg balance scale will be used for balance assessment. It has a total score of 56, with higher scores indicating better balance	8 weeks
Mobility	GMFM-88 scale will be used for assessment of mobility, particularly the subscales B,D and E related to mobility in sitting, standing and walking stances.	8 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Estimated): May 15, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Balance; Mobility; Spasticity; Physical Function Performance
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: FUI/CTR/2024/40

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