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

Primary Purpose

Diplegic Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Action Observation Theraoy
Functional Training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diplegic Cerebral Palsy focused on measuring Action observation therapy (AOT), Cerebral Palsy (CP)

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saidu Group of Teaching Hospital SwatRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Action Observation therapy

Functional Training Group

Arm Description

This group will perform exercises in stages. First stage consists of movements to improve balance in sitting position with exercises upright the pelvis, move weight forward, move weight to the left and right and rotate right and left. Second stage consist of sit to stand movements with exercises upright the pelvis in sitting position, move weight forward from a sitting position and stand up from a sitting position. Third stage consist of standing movements to improve balance with exercises move weight right and left, forward weight shift with right foot and left foot (lateral view) and forward weight shift with right foot and left foot (front view). Fourth stage consist of walking side ways to left and then towards right. Therapist will perform these tasks and video will be made which will play in front of patients.

participants including in this group will perform the tasks including lying to sitting position, moving in the sitting posture, sitting and standing up, posture training for learning a normal gait pattern, weight bearing and weight movement training in the straight posture, walking training on the flat floor, and stair walking

Outcomes

Primary Outcome Measures

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
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2022
Last Updated
February 23, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05655572
Brief Title
Comparison Between AOT and Functional Training on Balance, Mobility and Cognition in Diplegic Cerebral Palsy
Official Title
Comparison Between Action Observation Therapy and Functional Training on Balance, Mobility and Cognition in Diplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diplegic Cerebral Palsy
Keywords
Action observation therapy (AOT), Cerebral Palsy (CP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Action Observation therapy
Arm Type
Experimental
Arm Description
This group will perform exercises in stages. First stage consists of movements to improve balance in sitting position with exercises upright the pelvis, move weight forward, move weight to the left and right and rotate right and left. Second stage consist of sit to stand movements with exercises upright the pelvis in sitting position, move weight forward from a sitting position and stand up from a sitting position. Third stage consist of standing movements to improve balance with exercises move weight right and left, forward weight shift with right foot and left foot (lateral view) and forward weight shift with right foot and left foot (front view). Fourth stage consist of walking side ways to left and then towards right. Therapist will perform these tasks and video will be made which will play in front of patients.
Arm Title
Functional Training Group
Arm Type
Active Comparator
Arm Description
participants including in this group will perform the tasks including lying to sitting position, moving in the sitting posture, sitting and standing up, posture training for learning a normal gait pattern, weight bearing and weight movement training in the straight posture, walking training on the flat floor, and stair walking
Intervention Type
Other
Intervention Name(s)
Action Observation Theraoy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Functional Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Gross motor function measure
Description
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
Time Frame
6 weeks
Title
Pediatric Balance Scale (PBS)
Description
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.
Time Frame
6 weeks
Title
Timed 10 meter walk test
Description
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
Time Frame
6 weeks
Title
Mini-mental state pediatric examination (MMSPE)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Bashir, MSNMPT
Phone
03335256920
Email
Ayesha.bashir@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Bashir, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saidu Group of Teaching Hospital Swat
City
Swāt
State/Province
Khyberpakhtunkhuwa
ZIP/Postal Code
25000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayesha Bashir, MSNMPT
Phone
03335256920
Email
ayesha.bashir@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No

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

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