- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05655572
Comparison Between AOT and Functional Training on Balance, Mobility and Cognition in Diplegic Cerebral Palsy
Comparison Between Action Observation Therapy and Functional Training on Balance, Mobility and Cognition in Diplegic Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Khyberpakhtunkhuwa
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Swāt, Khyberpakhtunkhuwa, Pakistan, 25000
- Saidu Group of Teaching Hospital Swat
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Action Observation therapy
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.
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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
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Active Comparator: Functional Training Group
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
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gross motor function measure
Time Frame: 6 weeks
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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
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6 weeks
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Pediatric Balance Scale (PBS)
Time Frame: 6 weeks
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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.
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6 weeks
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Timed 10 meter walk test
Time Frame: 6 weeks
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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
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6 weeks
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Mini-mental state pediatric examination (MMSPE)
Time Frame: 6 weeks
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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.
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayesha Bashir, MSNMPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aizaz Ullah Khan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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