Cerebral Palsy (CP)NCT06672328
Action Observation Training for Functional Performance in Children with Cerebral Palsy
A study testing Training with Action Observation Therapy and Training without Action Observation Therapy in people with Cerebral Palsy (CP) and Physical Functional Performance, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study is a randomized control trial and aims to determine the effects of Action Observation on balance and mobility in patients with cerebral palsy compared to training without action observation. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP), Physical Functional Performance
- What is being tested?
- Training with Action Observation Therapy and Training without Action Observation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5-12.
- Spastic CP.
- Modified Ashworth Scale spasticity score 0-2
- GMFCS level I, II or III.
- Able to understand and follow commands, e.g. "Stand up, please".
- Able to sit to stand with or without assistance.
Who cannot join
- Any orthopedic procedure in the past 6 months, that could prevent exercise training.
- Any co-morbid condition such as spinal atrophy, osteogenesis imperfecta etc.
- History of chronic seizure attacks.
- Children with severe visual/hearing impairments.
- Presence of knee contractures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Thrapy
Islamabad, 44000
Furqan Ahmed Siddiqi, PhD, 051-5788171 ext. 602, principal.fucp@fui.edu.pk
About this study
This study is a randomized control trial and aims to determine the effects of Action Observation on balance and mobility in patients with cerebral palsy compared to training without action observation.
Read the detailed description
Effetcs of Action observation will be assessed for functional performance which includes the parameters of balance and mobility.
Spastic CP children agd 5-12 will be recruited in the study. The participants would be assessed through Modified Ashworth scale, GMFCS, Pediatrics balance scale and GMFM-88 .
Informed Consent will ne taken after which the participants will be recruited into the two groups, where one group will recieve training with Action observation and other group will receive training without Action observation.
Baseline and Post-treatment measurements will be taken for analysis.
- Being tested
- Training with Action Observation Therapy, Training without Action Observation Therapy
- Keywords
- Balance, Cerebral Palsy, Physical Function Performance, Mobility, Spasticity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with Action Observation TherapyProcedure or surgery
AOT based mobility and balance exercises along with conventional therapy consisting of simple lower limb stretchings and strengthening.
The fun based activities inlcude reaching for objects, tower building and taking turns in various stances.
Training without Action Observation TherapyProcedure or surgery
Cerebral Palsy patients will receive balance and mobility training without action observation in various stances of sitting, standing and turning.
Activities are fun based and include reaching for objects, tower building and taking turns in different positions.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | The participants will receive AOT based mobility and balance exercises along with conventional therapy consisting of simple lower limb stretchings and strengthening .
The AOT-based exercises include different exercises in sitting, standing and turning stances.
The fun based activities inlcude reaching for objects, tower building and taking turns in various stances. Receives: Procedure: Training with Action Observation Therapy |
| Control Group | Active comparator | The participants will receive mobility and balance exercises without Action Obseravtion along with conventional therapy consisting of simple lower limb stretchings and strengthening .
The AOT-based exercises include different exercises in sitting, standing and turning stances.
The fun based activities inlcude reaching for objects, tower building and taking turns in various stances. Receives: Procedure: Training without Action Observation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static balance
Pediatrics berg balance scale will be used for balance assessment. It has a total score of 56, with higher scores indicating better balance.
Measured: 8 weeks
Dynamic balance
Pediatrics berg balance scale will be used for balance assessment. It has a total score of 56, with higher scores indicating better balance
Measured: 8 weeks
Mobility
GMFM-88 scale will be used for assessment of mobility, particularly the subscales B,D and E related to mobility in sitting, standing and walking stances.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start10 Sep 2024
- Primary completion15 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672328
- Sponsor's protocol ID
- FUI/CTR/2024/40
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action Observation Training for Functional Performance in Children with Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06672328
- Acronym / sponsor ID
- FUI/CTR/2024/40
- Keywords
- Balance, Cerebral Palsy, Physical Function Performance, Mobility, Spasticity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 4 Nov 2024 (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.
This study is a randomized control trial and aims to determine the effects of Action Observation on balance and mobility in patients with cerebral palsy compared to training without action observation.
Detailed description
Effetcs of Action observation will be assessed for functional performance which includes the parameters of balance and mobility.
Spastic CP children agd 5-12 will be recruited in the study. The participants would be assessed through Modified Ashworth scale, GMFCS, Pediatrics balance scale and GMFM-88 .
Informed Consent will ne taken after which the participants will be recruited into the two groups, where one group will recieve training with Action observation and other group will receive training without Action observation.
Baseline and Post-treatment measurements will be taken for analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Procedure: Training with Action Observation TherapyThe participants will receive AOT based mobility and balance exercises along with conventional therapy consisting of simple lower limb stretchings and strengthening . The AOT-based exercises include different exercises in sitting, standing and turning stances. The fun based activities inlcude reaching for objects, tower building and taking turns in various stances. |
| Control Group | Active comparator | Procedure: Training without Action Observation TherapyThe participants will receive mobility and balance exercises without Action Obseravtion along with conventional therapy consisting of simple lower limb stretchings and strengthening . The AOT-based exercises include different exercises in sitting, standing and turning stances. The fun based activities inlcude reaching for objects, tower building and taking turns in various stances. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 5-12.
- Spastic CP.
- Modified Ashworth Scale spasticity score 0-2
- GMFCS level I, II or III.
- Able to understand and follow commands, e.g. "Stand up, please".
Key exclusion criteria (5 listed)
- Any orthopedic procedure in the past 6 months, that could prevent exercise training.
- Any co-morbid condition such as spinal atrophy, osteogenesis imperfecta etc.
- History of chronic seizure attacks.
- Children with severe visual/hearing impairments.
- Presence of knee contractures
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 |
|---|---|---|
| Training with Action Observation TherapyAOT based mobility and balance exercises along with conventional therapy consisting of simple lower limb stretchings and strengthening. The fun based activities inlcude reaching for objects, tower building and taking turns in various stances. | Procedure or surgery | Interventional Group |
| Training without Action Observation TherapyCerebral Palsy patients will receive balance and mobility training without action observation in various stances of sitting, standing and turning. Activities are fun based and include reaching for objects, tower building and taking turns in different positions. | Procedure or surgery | Control Group |
Primary outcome
Static balance
Time frame: 8 weeks
Pediatrics berg balance scale will be used for balance assessment. It has a total score of 56, with higher scores indicating better balance.
Dynamic balance
Time frame: 8 weeks
Pediatrics berg balance scale will be used for balance assessment. It has a total score of 56, with higher scores indicating better balance
Mobility
Time frame: 8 weeks
GMFM-88 scale will be used for assessment of mobility, particularly the subscales B,D and E related to mobility in sitting, standing and walking stances.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with Action Observation Therapy and Training without Action Observation Therapy in people with Cerebral Palsy (CP) and Physical Functional Performance, run by Foundation University Islamabad 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayesha Inam, DPT (+92332-5217887, ayesharwp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance (time frame: 8 weeks). The study lists 3 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 4 Nov 2024.