Cerebral PalsyNCT06198179
Effects of UP-CAT With and Without Visual Feedback in Children With CP
A study testing upper limb children action-observation training (UPCAT) and upper limb children action-observation training (UP-CAT) with visual feedback in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy (CP) is the most common neurological disorder of movement and/or posture and of motor function, which are due to a non-progressive interference or abnormality of the developing brain. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- upper limb children action-observation training (UPCAT) and upper limb children action-observation training (UP-CAT) with visual feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 5 Feb 2024
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cerebral palsy children aged 5 years to 10 years at the time of recruitment.
- Both male and female
- According to Modified Ashworth scale of spasticity; score should be +1.
- Mild or moderate UL disability i.e. active use of affected UL from poor active assist use to complete spontaneous use according to House Functional Classification System grade between 4 and 8.
Who cannot join
- Individuals with the other neurological deficits
- Visual impairment.
- Children with upper limb disabilities other than hemiplegic cerebral palsy.
- Children with uncontrolled epileptic seizures in last 3 years
- Non co-operative patients.
- Previous orthopedic surgery or botulinum toxin A (BoNT-A) injection in the UL within 6 months prior to the enrolment of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Upper Limb Children Action-observation Training (UP-CAT) With and Without Visual Feedback in Children With Cerebral Palsy
Cerebral palsy (CP) is the most common neurological disorder of movement and/or posture and of motor function, which are due to a non-progressive interference or abnormality of the developing brain. In hemiplegic cerebral palsy (HCP), one side of the body is involved with the upper extremity more affected than the lower. HCP is treated by addressing the underlying cause and by various form of therapy to recover motor function. Motor function in hemi paretic limb particularly fine motor skill may be improved by upper limb children action-observation therapy (UP-CAT).
Read the detailed description
This will be randomized controlled trial. Non-probability purposive sampling technique will be used for recruiting samples for study. Children will be assessed by House Functional Classification System for hemiplegia to include in the study. Computerized randomization will be used to locate subjects in two groups, and 28 hemiplegic cerebral palsy children will be divided into 2 groups; experimental and control groups. In experimental group hemiplegic cerebral palsy children will perform upper limb exercises with visual feedback for 5 times a week, 15 sets of daily life upper limb activities, each action will be observed for 2 minutes and executed for 2 minutes. In control group hemiplegic cerebral palsy children will perform upper limb activities for 5 times a week, 15 sets of daily life upper limb activities, each action will be observed for 2 minutes and executed for 2 minutes. Both groups will be assessed at the time of recruitment and at the end of 4 weeks. Data will be collected by Melbourne unilateral upper limb (MUUL) and ABILHAND-kids questionnaire. After collection of data, data will be analyzed by SPSS-25.
- Conditions
- Cerebral Palsy
- Being tested
- upper limb children action-observation training (UPCAT), upper limb children action-observation training (UP-CAT) with visual feedback
- Keywords
- Cerebral palsy (CP),, Rehabilitation, Upper extremity, Activities of daily living
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper limb children action-observation training (UPCAT)Other
upper limb children action-observation training (UPCAT) without visual Feedback
upper limb children action-observation training (UP-CAT) with visual feedbackOther
upper limb children action-observation training (UP-CAT) with visual feedback: Mirror therapy as visual feedback
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | these individuals will receive the upper limb children action-observation training (UP-CAT) with visual feedback
UP-CAT:
* Individual tasks like modelling compound,board games,cards,magnets,glass bead to do bracelets,painting and crafting (making a grass man,making musical instruments with cardboard),cooking (making juice cocktails,fruit skewers,chocolate fondue),building towers, making puzzles \& water games including filling a bucket with a sponge/bottle,filling \& throwing water balloons.
* To maximize the variety of the actions we included different objects (e.g.coins,bottles, stamps,modelling compound) to be grasped with different grasp types (whole hand,pinch, tripod grasp) and in different orientations of the wrist.
Visual feedback:
Mirror in front of patient will be used. After the baseline assessment,the patient in the experimental group will receive the upper limb children action-observation training with visual feedback Time of rehabilitation will be 1 hour/subject. Receives: Other: upper limb children action-observation training (UP-CAT) with visual feedback |
| Control group | Other | This will receive the upper limb children action-observation training (UP-CAT).
UP-CAT:
Following tasks will be performed by children
* Individual tasks like modelling compound,board games,cards,magnets,glass bead to do bracelets,painting and crafting (making a grass man,making musical instruments with cardboard),cooking (making juice cocktails,fruit skewers,chocolate fondue),building towers, making puzzles \& water games including filling a bucket with a sponge/bottle,filling \& throwing water balloons
* To maximize the variety of the actions we included different objects (e.g. coins,bottles, stamps,modelling compound) to be grasped with different grasp types (whole hand,pinch, tripod grasp) \& in different orientations of the wrist.After the baseline assessment,the patient in the experimental group will receive the UL children action-observation training with visual feedback Time of rehabilitation will be 1 hour per subject. Receives: Other: upper limb children action-observation training (UPCAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
The MUUL is an evaluative tool that measures unilateral upper extremity quality of movement in children with neurological impairments aged from 5 to 15 years. MUUL is a criterion-referenced test based on 16 items scored on a 3- to 5-point ordinal scale comprising tasks that are representative of the most important components of unilateral UL function
Measured: 4 weeks
ABILHAND-Kids
The ABILHAND-Kids is a short questionnaire that measures 21 mainly bimanual daily activities referred to the activity domain of the ICF. The difficulty experienced by the child to perform the required tasks is scored by a parent on a 3-point ordinal scale (impossible, difficult, and easy).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Model description
- This study will be randomized controlled trial (RCT) used to measure the effects of upper limb action-observation training (UP-CAT) with and without visual feedback in children with cerebral palsy. subjects with cerebral palsy meeting pre determined inclusion and exclusion criteria will be be divided into two groups using non-probability sampling techniques.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- IQRA Muhammad Afzal, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198179
- Sponsor's protocol ID
- REC/RCR&AHS/23/0753
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sgandurra G, Cecchi F, Beani E, Mannari I, Maselli M, Falotico FP, Inguaggiato E, Perazza S, Sicola E, Feys H, Klingels K, Ferrari A, Dario P, Boyd RN, Cioni G. Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. BMJ Open. 2018 May 14;8(5):e017819. doi: 10.1136/bmjopen-2017-017819.
PubMed 29764869
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Limb Children Action-observation Training (UP-CAT) With and Without Visual Feedback in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06198179
- Acronym / sponsor ID
- REC/RCR&AHS/23/0753
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy (CP),, Rehabilitation, Upper extremity, Activities of daily living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jan 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.
Cerebral palsy (CP) is the most common neurological disorder of movement and/or posture and of motor function, which are due to a non-progressive interference or abnormality of the developing brain. In hemiplegic cerebral palsy (HCP), one side of the body is involved with the upper extremity more affected than the lower. HCP is treated by addressing the underlying cause and by various form of therapy to recover motor function. Motor function in hemi paretic limb particularly fine motor skill may be improved by upper limb children action-observation therapy (UP-CAT).
Detailed description
This will be randomized controlled trial. Non-probability purposive sampling technique will be used for recruiting samples for study. Children will be assessed by House Functional Classification System for hemiplegia to include in the study. Computerized randomization will be used to locate subjects in two groups, and 28 hemiplegic cerebral palsy children will be divided into 2 groups; experimental and control groups. In experimental group hemiplegic cerebral palsy children will perform upper limb exercises with visual feedback for 5 times a week, 15 sets of daily life upper limb activities, each action will be observed for 2 minutes and executed for 2 minutes. In control group hemiplegic cerebral palsy children will perform upper limb activities for 5 times a week, 15 sets of daily life upper limb activities, each action will be observed for 2 minutes and executed for 2 minutes. Both groups will be assessed at the time of recruitment and at the end of 4 weeks. Data will be collected by Melbourne unilateral upper limb (MUUL) and ABILHAND-kids questionnaire. After collection of data, data will be analyzed by SPSS-25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be randomized controlled trial (RCT) used to measure the effects of upper limb action-observation training (UP-CAT) with and without visual feedback in children with cerebral palsy. subjects with cerebral palsy meeting pre determined inclusion and exclusion criteria will be be divided into two groups using non-probability sampling techniques.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: upper limb children action-observation training (UP-CAT) with visual feedbackthese individuals will receive the upper limb children action-observation training (UP-CAT) with visual feedback UP-CAT: * Individual tasks like modelling compound,board games,cards,magnets,glass bead to do bracelets,painting and crafting (making a grass man,making musical instruments with cardboard),cooking (making juice cocktails,fruit skewers,chocolate fondue),building towers, making puzzles \& water games including filling a bucket with a sponge/bottle,filling \& throwing water balloons. * To maximize the variety of the actions we included different objects (e.g.coins,bottles, stamps,modelling compound) to be grasped with different grasp types (whole hand,pinch, tripod grasp) and in different orientations of the wrist. Visual feedback: Mirror in front of patient will be used. After the baseline assessment,the patient in the experimental group will receive the upper limb children action-observation training with visual feedback Time of rehabilitation will be 1 hour/subject. |
| Control group | Other | Other: upper limb children action-observation training (UPCAT)This will receive the upper limb children action-observation training (UP-CAT). UP-CAT: Following tasks will be performed by children * Individual tasks like modelling compound,board games,cards,magnets,glass bead to do bracelets,painting and crafting (making a grass man,making musical instruments with cardboard),cooking (making juice cocktails,fruit skewers,chocolate fondue),building towers, making puzzles \& water games including filling a bucket with a sponge/bottle,filling \& throwing water balloons * To maximize the variety of the actions we included different objects (e.g. coins,bottles, stamps,modelling compound) to be grasped with different grasp types (whole hand,pinch, tripod grasp) \& in different orientations of the wrist.After the baseline assessment,the patient in the experimental group will receive the UL children action-observation training with visual feedback Time of rehabilitation will be 1 hour per subject. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Cerebral palsy children aged 5 years to 10 years at the time of recruitment.
- Both male and female
- According to Modified Ashworth scale of spasticity; score should be +1.
- Mild or moderate UL disability i.e. active use of affected UL from poor active assist use to complete spontaneous use according to House Functional Classification System grade between 4 and 8.
Key exclusion criteria (6 listed)
- Individuals with the other neurological deficits
- Visual impairment.
- Children with upper limb disabilities other than hemiplegic cerebral palsy.
- Children with uncontrolled epileptic seizures in last 3 years
- Non co-operative patients.
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 |
|---|---|---|
| upper limb children action-observation training (UPCAT)upper limb children action-observation training (UPCAT) without visual Feedback | Other | Control group |
| upper limb children action-observation training (UP-CAT) with visual feedbackupper limb children action-observation training (UP-CAT) with visual feedback: Mirror therapy as visual feedback | Other | Experimental group |
Primary outcome
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Time frame: 4 weeks
The MUUL is an evaluative tool that measures unilateral upper extremity quality of movement in children with neurological impairments aged from 5 to 15 years. MUUL is a criterion-referenced test based on 16 items scored on a 3- to 5-point ordinal scale comprising tasks that are representative of the most important components of unilateral UL function
ABILHAND-Kids
Time frame: 4 weeks
The ABILHAND-Kids is a short questionnaire that measures 21 mainly bimanual daily activities referred to the activity domain of the ICF. The difficulty experienced by the child to perform the required tasks is scored by a parent on a 3-point ordinal scale (impossible, difficult, and easy).
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 13 Jun 2024.
- Background: PubMed 29764869Sgandurra G, Cecchi F, Beani E, Mannari I, Maselli M, Falotico FP, Inguaggiato E, Perazza S, Sicola E, Feys H, Klingels K, Ferrari A, Dario P, Boyd RN, Cioni G. Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. BMJ Open. 2018 May 14;8(5):e017819. doi: 10.1136/bmjopen-2017-017819.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
IQRA Muhammad Afzal, MS* 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 upper limb children action-observation training (UPCAT) and upper limb children action-observation training (UP-CAT) with visual feedback in people with 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 6 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 13 Jun 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?
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?
Melbourne Assessment of Unilateral Upper Limb Function (MUUL) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198179, which also lists 1 linked publication.
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 13 Jun 2024.