Additional Effect of Visual Feedback Along With AOT on Balance,Mobility and Cognition in CP
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Action Observation Therapy
Action Observation Therapy along with visual feedback
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring action observation therapy, cerebral palsy, visual feedback
Eligibility Criteria
Inclusion Criteria: Without visual impairment and visual field defects Mini-Mental state examination for Children (MMC) score >25 GMFCS (gross motor function classification system) I-III Children with Modified Ashworth Scale (MAS) less than 2 Exclusion Criteria: Unable to walk Children with severe co-morbidities
Sites / Locations
- Center for Profound Education Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Action Observation Therapy
Visual feedback and Action Observation Therapy
Arm Description
exercises of AO protocol
Excercises of AO protocol infront of a mirror
Outcomes
Primary Outcome Measures
Gross Motor Function Classification Scale (GMFCS)
Gross Motor Function measure (GMFM) is the valid and standard observational instrument to measure change in gross motor function in CP children. The tool 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. At the end these score summed up into total score. The component B,C,D and E of GMFCS will be used in this study respectively.
Pediatric Balance Scale (PBS)
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 is easy to administrate. It includes 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
The test can be used to measure the gait ability and speed. The acceleration area 2.5m and deceleration area 2.5m can be marked on the ground as start and end point for the test. Participants are asked to walk for 15 minutes on comfortable flat floor at a comfortable speed and then the walking speed is recorded through stopwatch over 10 m between these points. The mean value of the three trials was used and expressed as m/s(14).
Mini Mental State Exam
It is a cognitive screening task and scoring system for 3 to 14 years old child (25). It is presented by 11 questions involving five basic cognitive abilities i.e. attention-concentration, orientation, registration, recall and language and constructive ability. 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
NCT ID
NCT05775315
First Posted
March 7, 2023
Last Updated
July 31, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05775315
Brief Title
Additional Effect of Visual Feedback Along With AOT on Balance,Mobility and Cognition in CP
Official Title
Additional Effects of Visual Feedback Along With Action Observation Therapy on Balance, Mobility and Cognition in Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
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 study aims to find the effectiveness of visual feedback along with action observation therapy in cerebral palsy. the effect of AOT on mobility, cognition and balance of the targeted population will be the intrest of the researcher
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
action observation therapy, cerebral palsy, visual feedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Action Observation Therapy
Arm Type
Experimental
Arm Description
exercises of AO protocol
Arm Title
Visual feedback and Action Observation Therapy
Arm Type
Active Comparator
Arm Description
Excercises of AO protocol infront of a mirror
Intervention Type
Other
Intervention Name(s)
Action Observation Therapy
Intervention Description
Exercises of AO protocol MOVEMENT TOTAL VIDEO TIME PATIENT TIME Upright the pelvis 1 minute 5 minutes Move weight forward 1 minute 5 minutes Move weight to the left and right 1 minute 5 minutes Rotate right and left 1 minute 5 minutes Upright the pelvis in sitting position 1 minute 5 minutes Move weight forward from a sitting position 1 minute 5 minutes Stand up from a sitting position 1 minute 5 minutes Move weight right and left 1 minute 5 minutes Forward weight shift with right foot and left foot 1 minute 5 minutes Walking sideways to left 1 minute 5 minutes Walking sideways to right 1 minute 5 minutes
Rest time between watching and performing each video will be 1 minute. the exercises will be done 3 times a week.
Intervention Type
Other
Intervention Name(s)
Action Observation Therapy along with visual feedback
Intervention Description
Exercises of AO protocol in front of a mirror MOVEMENT TOTAL VIDEO TIME PATIENT TIME Upright the pelvis 1 minute 5 minutes Move weight forward 1 minute 5 minutes Move weight to the left and right 1 minute 5 minutes Rotate right and left 1 minute 5 minutes Upright the pelvis in sitting position 1 minute 5 minutes Move weight forward from a sitting position 1 minute 5 minutes Stand up from a sitting position 1 minute 5 minutes Move weight right and left 1 minute 5 minutes Forward weight shift with right foot and left foot 1 minute 5 minutes Walking sideways to left 1 minute 5 minutes Walking sideways to right 1 minute 5 minutes
Rest time between watching and performing each video will be 1 minute. the exercises will be done 3 times a week.
Primary Outcome Measure Information:
Title
Gross Motor Function Classification Scale (GMFCS)
Description
Gross Motor Function measure (GMFM) is the valid and standard observational instrument to measure change in gross motor function in CP children. The tool 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. At the end these score summed up into total score. The component B,C,D and E of GMFCS will be used in this study respectively.
Time Frame
12 weeks
Title
Pediatric Balance Scale (PBS)
Description
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 is easy to administrate. It includes 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
12 weeks
Title
Timed 10-meter walk test
Description
The test can be used to measure the gait ability and speed. The acceleration area 2.5m and deceleration area 2.5m can be marked on the ground as start and end point for the test. Participants are asked to walk for 15 minutes on comfortable flat floor at a comfortable speed and then the walking speed is recorded through stopwatch over 10 m between these points. The mean value of the three trials was used and expressed as m/s(14).
Time Frame
12 weeks
Title
Mini Mental State Exam
Description
It is a cognitive screening task and scoring system for 3 to 14 years old child (25). It is presented by 11 questions involving five basic cognitive abilities i.e. attention-concentration, orientation, registration, recall and language and constructive ability. 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
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Without visual impairment and visual field defects
Mini-Mental state examination for Children (MMC) score >25
GMFCS (gross motor function classification system) I-III
Children with Modified Ashworth Scale (MAS) less than 2
Exclusion Criteria:
Unable to walk
Children with severe co-morbidities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Bashir
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Profound Education Trust
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Additional Effect of Visual Feedback Along With AOT on Balance,Mobility and Cognition in CP
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