Diplegic Cerebral PalsyNCT05655572
Comparison Between AOT and Functional Training on Balance, Mobility and Cognition in Diplegic Cerebral Palsy
A study testing Action Observation Theraoy and Functional Training in people with Diplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Diplegic Cerebral Palsy
- What is being tested?
- Action Observation Theraoy and Functional Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2022to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Saidu Group of Teaching Hospital Swat
Swāt, Khyberpakhtunkhuwa, 25000
About this study
Official title: Comparison Between Action Observation Therapy and Functional Training on Balance, Mobility and Cognition in Diplegic Cerebral Palsy
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.
Read the 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.
- Conditions
- Diplegic Cerebral Palsy
- Being tested
- Action Observation Theraoy, Functional Training
- Keywords
- Action observation therapy (AOT), Cerebral Palsy (CP)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation TheraoyOther
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 TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Action Observation therapy | Experimental | 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. Receives: Other: Action Observation Theraoy |
| Functional Training Group | Active comparator | 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 Receives: Other: Functional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
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.
Measured: 6 weeks
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
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Apr 2022
- Primary completion15 Jul 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplegic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Bashir, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655572
- Sponsor's protocol ID
- Aizaz Ullah Khan
- Status last verified
- Nov 2025
- First submitted
- 9 Dec 2022
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Action Observation Therapy and Functional Training on Balance, Mobility and Cognition in Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05655572
- Acronym / sponsor ID
- Aizaz Ullah Khan
- Conditions
- Diplegic Cerebral Palsy
- Keywords
- Action observation therapy (AOT), Cerebral Palsy (CP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action Observation therapy | Experimental | Other: Action Observation TheraoyThis 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. |
| Functional Training Group | Active comparator | Other: Functional Trainingparticipants 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 |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation TheraoyAfter 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 | Other | Action Observation therapy |
| Functional Trainingafter 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 | Other | Functional Training Group |
Primary outcome
Gross motor function measure
Time frame: 6 weeks
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)
Time frame: 6 weeks
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
Time frame: 6 weeks
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)
Time frame: 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Diplegic Cerebral Palsy
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Not yet recruiting
Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegia Cerebral Palsy
Recruiting
Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy
Spastic Diplegic Cerebral Palsy
Recruiting
Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Balance and Executive Functions in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegic Cerebral Palsy
Active, not recruiting
Therapeutic Listening for Balance and Trunk Control in Children With Cerebral Palsy
Spastic Diplegic Cerebral Palsy, Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayesha Bashir, MSNMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Theraoy and Functional Training in people with Diplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross motor function measure (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025; AzTrials last refreshed its copy on 29 Oct 2026.