Comparison Between AOT and Functional Training on Balance, Mobility and Cognition in Diplegic Cerebral Palsy

Diplegic Cerebral Palsy Clinical Trial

Official title:

Comparison Between Action Observation Therapy and Functional Training on Balance, Mobility and Cognition in Diplegic Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05655572
• Other study ID #: Aizaz Ullah Khan
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: February 2023
• Source: Riphah International University
• Contact: Ayesha Bashir, MSNMPT
• Phone: 03335256920
• Email: Ayesha.bashir[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to find out the effects of Action observation therapy as compared to the traditional physiotherapy in diplegic spastic cerebral palsy patients. We will check the effects on balance mobility and cognition of patients.

Description:

A study conducted in 2020 on diplegic CP patients. The action observation training group repeatedly practiced the action with their motor skills, while the control group practiced conventional physical therapy. Results suggest that action observation training is both feasible and beneficial for improving spasticity, gross motor function, and balance in children with spastic diplegia cerebral palsy. One of the researcher evaluated the evidence of using Action Observation Therapy in the rehabilitation of children with Cerebral Palsy. It was Systematic review with meta-analysis. No evidence of benefit had been found to draw a firm conclusion regarding the effectiveness of action observation therapy in the rehabilitation of children with cerebral palsy due to limitations in methodological quality and variations between studies. Some also, investigated the effects of VR-based intervention by means of active videogame on self-concept, balance, motor performance and adaptive success in children with CP. They concluded that VR-based intervention might interfere with the way children with CP perceive themselves, apart from improve their balance, motor performance and adaptive success. Thus VR-based intervention is a potential tool to assist rehabilitation professionals to improve these aspects of children's health condition. Similarly, A study concluded that Action observation therapy is beneficial in rehabilitation of neurological and musculoskeletal conditions. A study concluded that action observation along with gait training provides greater benefits for gait and cognitive performance in elderly with MCI. According to a scientist action observation therapy is effective and feasible for functional mobility in rehabilitation processes. A researcher in his study action observation therapy is more effective in improving upper limb movements and functions. There are various studies on movement observation training but most of them are related to restoring the upper limb function of stroke and cerebral palsy patients, and studies on the mobility, cognition, and balance in cerebral palsy for movement observation training are sparse so this study will contribute in examining improvements in rehabilitation of children with diplegic cerebral palsy by demonstrating the effects of action observation training and conventional therapy for the treatment of mobility, cognition, and balance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: August 30, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

Inclusion Criteria:

• Diagnosed Diaplegic Spastic CP between the age of 5 to 11 years.
• Able to follow the researcher's instruction.
• GMFCS (gross motor function classification system) level I-III
• Children with a modified ashworth scale (MAS) of = 3.

Exclusion Criteria:

• Unable to walk
• Children with severe co-morbidities like musculoskeletal deformities, spina bifida and other types of Cerebral Palsy.
• With visual impairment and visual field defects

Related Conditions & MeSH terms

• Cerebral Palsy
• Diplegic Cerebral Palsy
• Paralysis

Intervention

Other:
• Action Observation Theraoy
After initial baseline assessment patients allocated in AOT group will undergo treatment protocol of 6 weeks having 4 stages of duration 1.5 weeks each performed 3 days per week. . Assessment will be perform at baseline after 2, 4 and 6 weeks
• Functional Training
after baseline assessment participants including in this group will perform the tasks for 6 weeks (3 days per week) s and after that again assessment will be made for examining the improvements.Assessment will be perform at baseline after 2 ,4 and 6 weeks

Locations

Country	Name	City	State
Pakistan	Saidu Group of Teaching Hospital Swat	Swat	Khyberpakhtunkhuwa

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross motor function measure	Changes form the baseline Gross Motor Function measure (GMFM) is the valid and standard observational instrument to measure change in gross motor function in CP children. It consists of 66 items with 5 dimensions. These dimensions are the major motor functions i.e. supine/rolling, sitting, crawling/kneeling, standing and walking/running/jumping. Each task is rated according to the scoring guidelines i.e. higher score indicated better gross motor function. Each GMFM item is graded on 4-point scale i.e. 0 for unable to initiate the task, 1 for able to initiate the task, 2 for able to perform the task partially and 3 for able to perform the task completely	6 weeks
Primary	Pediatric Balance Scale (PBS)	Changes from the baseline Pediatric Balance Scale (PBS) is a modified form of Berg Balance Scale (BSS) which was developed for balance measurement in CP child. It can be performed without specialized equipment and can be easily administered. It including 14 items with 5-level grading to assess the functional activities that child must safely and independently form at home, community, activities including sitting balance, sit to stand/stand to sit, transfer, stepping, reaching forward, reaching to floor, turning and stepping on and off at elevated surface. Each activity is rated according to scale from 0 to 4 i.e. 0 for unable to perform and 4 for able to perform without difficulty.	6 weeks
Primary	Timed 10 meter walk test	Changes from baseline Timed 10 meter walk test was used to measure the gait ability and speed. The acceleration area 2.5m and deceleration area 2.5m were marked on the ground as start and end point for the test. Participants were asked to walk for 15 minutes on comfortable flat floor at a comfortable speed and then record the walking speed through stopwatch over 10 m between these point	6 weeks
Primary	Mini-mental state pediatric examination (MMSPE)	Changes from baseline Mini-mental state pediatric examination (MMSPE) is a cognitive screening task and scoring system for 3 to 14 years old child. It represented 11 questions involving five basic cognitive abilities i.e. attention-concentration, orientation, registration, recall and language and constructive ability. (22) The possible score range is from 0 to 37, from which 17 or lower score indicating as moderate to severe cognitive impairment of children.	6 weeks