Cerebral PalsyNCT06407882
Effects of Conductive Exercises on Motor Skills Among the Children With CP
A study testing Conductive Exercises and Routine Physical Therapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy (CP) is defined as a neurodevelopmental disorder in which there are abnormalities of motor skills, muscle tone ,and, movement and is caused by injury to the developing brain. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Conductive Exercises and Routine Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2024to 30 Jul 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spastic cerebral palsy
- GMFCS level I, II and III
- Age group 6 to 12 years
- Either gender
Who cannot join
- Had a botulinum injection for reduce spasticity
- Subjects with any cardiac problem(congenitally)
- Children who are having visual and hearing deficits
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects pf Conductive Exercises on Motor Skills Among the Children With Cerebral Palsy
Cerebral palsy (CP) is defined as a neurodevelopmental disorder in which there are abnormalities of motor skills, muscle tone ,and, movement and is caused by injury to the developing brain. Risk factors for cerebral palsy are most probably intrauterine exposure to infection or inflammation and disorders of coagulation.Cerebral palsy (CP) is classified as Spastic, Athetoid, Tremor, Rigidity, Ataxic, Atonic, and Mixed.
Cerebral Palsy (CP) is the most common cause of physical disability in early childhood and overall, the CP rate is between 2 and 3 per 1000 live births.There are several interventions to manage cerebral palsy depending upon the severity and type of cerebral palsy and hence requires a multidisciplinary setting for proper improvement and management.One of the important intervention is conductive education including conductive exercises (CE).
Conductive education (CE) is a useful educational system for the management of motor disabled individuals whose disability and dysfunction was due to the damage to the central nervous system, mainly at the pre-, peri- or post-natal period of life. Conductive exercises basically include task-oriented learning within highly structured programs and conductors who are trained in special education and therapy administer the conductive education program.
Read the detailed description
Group A: Experimental group:
Group A will perform Conductive exercises (CE) in addition to routine physical therapy. Conductive exercises program will include Squat-position, Rising from squat to stand, Sitting on the stool, Prone lying, High kneeling and half kneeling, Sitting, lying and high kneeling, Walking in parallel bars, Sitting to standing, Floor to standing, Picking up toys from the floor, Balance on one foot on different surfaces and heights, Crawling over foams of different sizes and shapes, Climbing steps or stairs sometimes while carrying a toy. These exercises will improve motor skills and activities of daily living by improving the muscle strength.
Group B: Control group:
Group B will perform routine physical therapy (RPT) alone. Active and passive movements, Passive stretching, strengthening exercises, weight bearing exercises.
Both the groups will receive intervention for 45 minutes per session 5 days in a week for 2 month. Data will be collected at baseline and after the completion of the study. Data will be collected after ethical approval and consent. All the personal information of the patient will be kept confidential.
- Conditions
- Cerebral Palsy
- Being tested
- Conductive Exercises, Routine Physical Therapy
- Keywords
- ADLS,, Cerebral palsy,, Motor skills,, Quality of life
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conductive ExercisesBehavioural
Conductive education (CE) is a useful educational system for the management of motor disabled individuals whose disability and dysfunction was due to the damage to the central nervous system, mainly at the pre-, peri- or post-natal period of life. Conductive exercises basically include task-oriented learning within highly structured programs and conductors who are trained in special education and therapy administer the conductive education program
Routine Physical TherapyBehavioural
Group B will perform routine physical therapy (RPT) alone. Active and passive movements, Passive stretching, strengthening exercises, weight bearing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Group A will perform Conductive exercises (CE) in addition to routine physical therapy. Conductive exercises program will include Squat-position, Rising from squat to stand, Sitting on the stool, Prone lying, High kneeling and half kneeling, Sitting, lying and high kneeling, Walking in parallel bars, Sitting to standing, Floor to standing, Picking up toys from the floor, Balance on one foot on different surfaces and heights, Crawling over foams of different sizes and shapes, Climbing steps or stairs sometimes while carrying a toy. These exercises will improve motor skills and activities of daily living by improving the muscle strength Receives: Behavioral: Conductive Exercises |
| Routine Physical Therapy | Active comparator | Group B will perform routine physical therapy (RPT) alone. Active and passive movements, Passive stretching, strengthening exercises, weight bearing exercises. Receives: Behavioral: Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor function measure-88 (GMFM-88)
The Gross Motor Function Measure-88 (GMFM88) is a tool which is used to measure changes in gross motor function in cerebral palsy children and has been commonly used by researchers .The GMFM-88 consists of 88 items in five dimensions which are lying and rolling (GMFM-A); sitting (GMFM-B); crawling and kneeling (GMFM-C); standing (GMFM-D); and walking, running and jumping (GMFM-E).The psychometric properties of the adapted GMFM-88 for children with CP are reliable.
Measured: 8 weeks
Cerebral Palsy Quality of Life Questionnaire (CP QOL)
The Cerebral Palsy Quality of Life for Children (CP QOL-Child) was made to assess several aspects of subjective happiness and well-being, rather than ill-being or functioning. It is productive to establish a profile of qualify of life of cerebral palsy children to understand their subjective perception of their life.The reliability and validity of the CP QOL-Child have been established, including internal consistency, test-retest reliability, and construct validity
Measured: 8 weeks
ABILHAND questionnaire
This questionnaire is used to evaluate the effects of interventions that are useful for improving functional limitations under the different contextual situations.This is a valid and reliable assessment method which is used to assess a child's both unimanual and bimanual upper limb activities.This questionnaire focuses on the child's manual performance of 21 daily activities as perceived by the parents
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 posted9 May 2024
- Study start15 May 2024
- Primary completion15 Jul 2024
- Study completion30 Jul 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
- It will be Randomized control trial in which non probabilty convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will only receive Conductive education and group B will receive conventional physical therapy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moneeza Ahmad, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407882
- Sponsor's protocol ID
- REC/RCR&AHS/23/07103
- Status last verified
- Jul 2024
- First submitted
- 6 May 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gulati S, Sondhi V. Cerebral Palsy: An Overview. Indian J Pediatr. 2018 Nov;85(11):1006-1016. doi: 10.1007/s12098-017-2475-1. Epub 2017 Nov 20.
PubMed 29152685
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects pf Conductive Exercises on Motor Skills Among the Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06407882
- Acronym / sponsor ID
- REC/RCR&AHS/23/07103
- Conditions
- Cerebral Palsy
- Keywords
- ADLS,, Cerebral palsy,, Motor skills,, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 9 May 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 defined as a neurodevelopmental disorder in which there are abnormalities of motor skills, muscle tone ,and, movement and is caused by injury to the developing brain. Risk factors for cerebral palsy are most probably intrauterine exposure to infection or inflammation and disorders of coagulation.Cerebral palsy (CP) is classified as Spastic, Athetoid, Tremor, Rigidity, Ataxic, Atonic, and Mixed.
Cerebral Palsy (CP) is the most common cause of physical disability in early childhood and overall, the CP rate is between 2 and 3 per 1000 live births.There are several interventions to manage cerebral palsy depending upon the severity and type of cerebral palsy and hence requires a multidisciplinary setting for proper improvement and management.One of the important intervention is conductive education including conductive exercises (CE).
Conductive education (CE) is a useful educational system for the management of motor disabled individuals whose disability and dysfunction was due to the damage to the central nervous system, mainly at the pre-, peri- or post-natal period of life. Conductive exercises basically include task-oriented learning within highly structured programs and conductors who are trained in special education and therapy administer the conductive education program.
Detailed description
Group A: Experimental group:
Group A will perform Conductive exercises (CE) in addition to routine physical therapy. Conductive exercises program will include Squat-position, Rising from squat to stand, Sitting on the stool, Prone lying, High kneeling and half kneeling, Sitting, lying and high kneeling, Walking in parallel bars, Sitting to standing, Floor to standing, Picking up toys from the floor, Balance on one foot on different surfaces and heights, Crawling over foams of different sizes and shapes, Climbing steps or stairs sometimes while carrying a toy. These exercises will improve motor skills and activities of daily living by improving the muscle strength.
Group B: Control group:
Group B will perform routine physical therapy (RPT) alone. Active and passive movements, Passive stretching, strengthening exercises, weight bearing exercises.
Both the groups will receive intervention for 45 minutes per session 5 days in a week for 2 month. Data will be collected at baseline and after the completion of the study. Data will be collected after ethical approval and consent. All the personal information of the patient will be kept confidential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be Randomized control trial in which non probabilty convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will only receive Conductive education and group B will receive conventional physical therapy.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Conductive ExercisesGroup A will perform Conductive exercises (CE) in addition to routine physical therapy. Conductive exercises program will include Squat-position, Rising from squat to stand, Sitting on the stool, Prone lying, High kneeling and half kneeling, Sitting, lying and high kneeling, Walking in parallel bars, Sitting to standing, Floor to standing, Picking up toys from the floor, Balance on one foot on different surfaces and heights, Crawling over foams of different sizes and shapes, Climbing steps or stairs sometimes while carrying a toy. These exercises will improve motor skills and activities of daily living by improving the muscle strength |
| Routine Physical Therapy | Active comparator | Behavioral: Routine Physical TherapyGroup B will perform routine physical therapy (RPT) alone. Active and passive movements, Passive stretching, strengthening exercises, weight bearing exercises. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Spastic cerebral palsy
- GMFCS level I, II and III
- Age group 6 to 12 years
- Either gender
Key exclusion criteria (3 listed)
- Had a botulinum injection for reduce spasticity
- Subjects with any cardiac problem(congenitally)
- Children who are having visual and hearing deficits
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 |
|---|---|---|
| Conductive ExercisesConductive education (CE) is a useful educational system for the management of motor disabled individuals whose disability and dysfunction was due to the damage to the central nervous system, mainly at the pre-, peri- or post-natal period of life. Conductive exercises basically include task-oriented learning within highly structured programs and conductors who are trained in special education and therapy administer the conductive education program | Behavioural | Experimental Group |
| Routine Physical TherapyGroup B will perform routine physical therapy (RPT) alone. Active and passive movements, Passive stretching, strengthening exercises, weight bearing exercises. | Behavioural | Routine Physical Therapy |
Primary outcome
Gross motor function measure-88 (GMFM-88)
Time frame: 8 weeks
The Gross Motor Function Measure-88 (GMFM88) is a tool which is used to measure changes in gross motor function in cerebral palsy children and has been commonly used by researchers .The GMFM-88 consists of 88 items in five dimensions which are lying and rolling (GMFM-A); sitting (GMFM-B); crawling and kneeling (GMFM-C); standing (GMFM-D); and walking, running and jumping (GMFM-E).The psychometric properties of the adapted GMFM-88 for children with CP are reliable.
Cerebral Palsy Quality of Life Questionnaire (CP QOL)
Time frame: 8 weeks
The Cerebral Palsy Quality of Life for Children (CP QOL-Child) was made to assess several aspects of subjective happiness and well-being, rather than ill-being or functioning. It is productive to establish a profile of qualify of life of cerebral palsy children to understand their subjective perception of their life.The reliability and validity of the CP QOL-Child have been established, including internal consistency, test-retest reliability, and construct validity
ABILHAND questionnaire
Time frame: 8 weeks
This questionnaire is used to evaluate the effects of interventions that are useful for improving functional limitations under the different contextual situations.This is a valid and reliable assessment method which is used to assess a child's both unimanual and bimanual upper limb activities.This questionnaire focuses on the child's manual performance of 21 daily activities as perceived by the parents
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 2 Aug 2024.
- Background: PubMed 29152685Gulati S, Sondhi V. Cerebral Palsy: An Overview. Indian J Pediatr. 2018 Nov;85(11):1006-1016. doi: 10.1007/s12098-017-2475-1. Epub 2017 Nov 20.
- 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.
Moneeza Ahmad, 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 Conductive Exercises and Routine Physical Therapy 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 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 2 Aug 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?
Gross motor function measure-88 (GMFM-88) (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?
On the ClinicalTrials.gov record for NCT06407882, 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 2 Aug 2024.