Hemiplegic Cerebral PalsyNCT06459505
Adapted Physical Activities in Hemiplegic Cerebral Palsy
A study testing Routine or standard Physical Therapy and Adapted Physical Activity in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The rehabilitation process is critical for people with disabilities, and it appears reasonable to predict that adaptive physical activity will become an important instrument for holistic development in a human rights perspective within an ecological framework. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Routine or standard Physical Therapy and Adapted Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2024to 15 Aug 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with hemiplegic cerebral palsy who have been diagnosed fall within the age range of 7 to 11 years.
- GMFCS will be hired at the I-II level.
- Individuals with steady health conditions
Who cannot join
- Diseases or traumas that would make physical therapy inappropriate or dangerous.
- Have previously engaged in a comparable program for adaptive physical activity
- Leave out kids who have recently had Botox injections
- Inability to commit to the study protocol or attend scheduled therapy sessions
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab, Pakistan, 54000
About this study
Official title: Effects of Adapted Physical Activities in Children With Hemiplegic Cerebral Palsy
The rehabilitation process is critical for people with disabilities, and it appears reasonable to predict that adaptive physical activity will become an important instrument for holistic development in a human rights perspective within an ecological framework. To highlight appropriate physical activity and emphasise its importance as a space for social expression while designing rehabilitation and social inclusion procedures, as well as determining what the lines are and how to approach them. Cerebral palsy (CP) refers to a group of mobility and posture abnormalities caused by non-progressive interference in the growing brain.
This randomised controlled trial will recruit patients using non-probability convenience sampling. Data will be gathered from the Pakistan Society of Rehabilitation Sciences (PSRD) and Behaviour and Special Education Services (BASES). Children diagnosed with hemiplegic cerebral palsy will be included. Patients will be placed into two groups: group 1 will receive an adapted physical activity program, while group 2 will receive conventional care/routine physical therapy. Both groups will receive 30-minute sessions per day, three days a week, for six weeks. The study will use pre- and post-test assessments of patients using the Manual Ability Classification Scale, Gross Motor Function Measure, Goal Attainment Scale, and Lower Extremity Functional Scale.The data will be analysed with SPSS version 25 software.
Read the detailed description
GROUP A will receive pre-intervention evaluation that includes baseline measurements using the Manual Ability Classification Scale (MACS), Paediatric Evaluation of Disability Inventory (PEDI), Goal Attainment Scale (GAS), and Lower Extremity Functional Scale (LEFS) at 0 weeks.Participants will receive the modified physical activity program, the experimental group will take part. This program will involve adapted exercises, physical therapy, or modified sports, all aimed at meeting the unique requirements and difficulties faced by people with hemiplegic cerebral palsy and will help them improve their dynamic balance, equilibrium, strength and flexibility. Daily video recordings will be used to collect feedback. Mothers will participate in therapy sessions. Utilizing appropriate assessment instruments and outcome measures, the experimental group's advancement and results will be continuously observed and evaluated. For upper extremity participants will be categorized according to their the MACS level. The levels range from I (able to handle objects easily) to V (limited ability to handle objects). Interventions should be individualized based on the specific needs identified through the MACS assessment. The levels go from I, which is an easy level of object handling, to V, which is a limited degree of object handling. Individualized interventions should be developed in accordance with the unique needs that the MACS evaluation has revealed. Treatment session of 30 minutes per day for three days a week, for six weeks for each participant. After that post-test assessment will be conducted through MACS, PEDI, GAS and LEFS.
Group B will have regular therapy or conventional care that is normally given to people with hemiplegic cerebral palsy. The same evaluation instruments and outcome measures that are used for the experimental group will also be used for the control group's monitoring and assessment. Each participant will receive 30 minutes of treatment three days per week for 6 weeks, spread out over four days of the week. Following that, post-test evaluations using MACS, PEDI, GAS, and LEFS will be carried out.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Routine or standard Physical Therapy, Adapted Physical Activity
- Keywords
- Cerebral Palsy, Hemiplegia , Adapted Physical Activities.
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine or standard Physical TherapyOther
Participants will undergo physical therapy to stop abnormal movement patterns and restore control over output in the developmental sequence. Therapists will provide cues to elicit basic posture and movement patterns, inhibiting aberrant patterns. The therapy aims to promote normal posture and movement patterns, incorporating the hemiplegic side for symmetry and functional use. Active usage and targeted strengthening activities will be emphasized, with motor performance practice included.
Adapted Physical ActivityOther
For Upper extremities, Manual Ability Classification Scale (MACS) is a tool designed to support individuals with hemiplegic cerebral palsy by providing structured support through activities focusing on strength, flexibility, balance, and coordination. Participants at different MACS levels receive tailored treatments, including adaptive tools, task-specific training, assistive gadgets, and functional training. For lower extremities, the therapy will begin on stable support surfaces before progressing to more challenging surfaces such as inflatable cushions, foam pads, or balance discs, focusing on slow and controlled motions for improved body alignment and coordination.
| Study group | Role | What they receive |
|---|---|---|
| Routine or standard Physical Therapy Group | Active comparator | This group will receive routine or conventional physical therapy. Receives: Other: Routine or standard Physical Therapy |
| Adapted Physical Activity Group | Experimental | This group will receive Adapted Physical Activities. Receives: Other: Adapted Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual Classification Scale of Ability (MACS)
This tool was created to categorise people with cerebral palsy according to their manual abilities. Based on an individual's self-initiated ability to handle objects, it offers a five-level rating system that emphasises hand use throughout daily activities. Reliability between tests; r = (ICC = 0.984). Mini-MACS and the Gross Motor Function Classification System were found to be correlated (r = 0.626, 0.596, and 0.598)
Measured: 6 weeks
Pediatric Evaluation of Disability Inventory (PEDI)
Use of the Pediatric Evaluation of Disability Inventory (PEDI): This assessment tool assesses children with impairments' performance and functional abilities. Researchers, therapists, and healthcare professionals frequently utilize the PEDI to evaluate a child's abilities in a variety of daily life domains. ICC = 0.845-0.938, Cronbach's alpha = 0.889-0.964
Measured: 6 weeks
Goal Attainment Scale (GAS)
An outcome measure intended to evaluate how well people accomplish their objectives over the course of a given intervention or treatment period. It is frequently employed in several industries, such as healthcare, education, and rehabilitation. GAS is a versatile instrument in evaluating progress towards customised targets since it enables the individualization of goal setting and outcome evaluation. Reliability between and within testers (ICC=0.98)
Measured: 6 weeks
Lower Extremity Functional Scale (LEFS):
Frequently use to evaluate the functional status of patients with musculoskeletal disorders of the lower extremities. It is frequently used to gauge a person's capacity for carrying out different tasks linked to lower limb function in orthopaedic and physical therapy settings. The LEFS often asks about a person's capacity for carrying out routine tasks including running, jumping, walking, and stair climbing. The overall functional status of the lower extremities is assessed using the ratings that respondents provide on a scale for each activity. Intraclass correlation values (ICC=0.85-0.99) and Pearson correlation=(>0.7)
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 posted14 Jun 2024
- Study start30 Jun 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 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 Hemiplegic 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
- Parallel Assignment It will be Randomized control trial in which non probabilty convenient sampling will be used. Two groups of 7-11 age will be formed in which participants will be randomly divided. Group A will Adapted Physical Activities and group B will only receive conventional Physical Therapy used for hemiplegic cerebral palsy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Mangrio, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459505
- Sponsor's protocol ID
- REC/RCR & AHS/23/0789
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sit C, Aubert S, Carty C, Silva DAS, Lopez-Gil JF, Asunta P, Palad Y, Guisihan R, Lee J, Arbour Nicitopoulos KP, Vanderloo LM, Stanish H, Haegele J, Urbanski PK, Pozeriene J, Hutzler Y, Ng K. Promoting Physical Activity Among Children and Adolescents With Disabilities: The Translation of Policy to Practice Internationally. J Phys Act Health. 2022 Oct 22;19(11):758-768. doi: 10.1123/jpah.2022-0351. Print 2022 Nov 1.
PubMed 36280232
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adapted Physical Activities in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06459505
- Acronym / sponsor ID
- REC/RCR & AHS/23/0789
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Cerebral Palsy, Hemiplegia , Adapted Physical Activities.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 14 Jun 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.
The rehabilitation process is critical for people with disabilities, and it appears reasonable to predict that adaptive physical activity will become an important instrument for holistic development in a human rights perspective within an ecological framework. To highlight appropriate physical activity and emphasise its importance as a space for social expression while designing rehabilitation and social inclusion procedures, as well as determining what the lines are and how to approach them. Cerebral palsy (CP) refers to a group of mobility and posture abnormalities caused by non-progressive interference in the growing brain.
This randomised controlled trial will recruit patients using non-probability convenience sampling. Data will be gathered from the Pakistan Society of Rehabilitation Sciences (PSRD) and Behaviour and Special Education Services (BASES). Children diagnosed with hemiplegic cerebral palsy will be included. Patients will be placed into two groups: group 1 will receive an adapted physical activity program, while group 2 will receive conventional care/routine physical therapy. Both groups will receive 30-minute sessions per day, three days a week, for six weeks. The study will use pre- and post-test assessments of patients using the Manual Ability Classification Scale, Gross Motor Function Measure, Goal Attainment Scale, and Lower Extremity Functional Scale.The data will be analysed with SPSS version 25 software.
Detailed description
GROUP A will receive pre-intervention evaluation that includes baseline measurements using the Manual Ability Classification Scale (MACS), Paediatric Evaluation of Disability Inventory (PEDI), Goal Attainment Scale (GAS), and Lower Extremity Functional Scale (LEFS) at 0 weeks.Participants will receive the modified physical activity program, the experimental group will take part. This program will involve adapted exercises, physical therapy, or modified sports, all aimed at meeting the unique requirements and difficulties faced by people with hemiplegic cerebral palsy and will help them improve their dynamic balance, equilibrium, strength and flexibility. Daily video recordings will be used to collect feedback. Mothers will participate in therapy sessions. Utilizing appropriate assessment instruments and outcome measures, the experimental group's advancement and results will be continuously observed and evaluated. For upper extremity participants will be categorized according to their the MACS level. The levels range from I (able to handle objects easily) to V (limited ability to handle objects). Interventions should be individualized based on the specific needs identified through the MACS assessment. The levels go from I, which is an easy level of object handling, to V, which is a limited degree of object handling. Individualized interventions should be developed in accordance with the unique needs that the MACS evaluation has revealed. Treatment session of 30 minutes per day for three days a week, for six weeks for each participant. After that post-test assessment will be conducted through MACS, PEDI, GAS and LEFS.
Group B will have regular therapy or conventional care that is normally given to people with hemiplegic cerebral palsy. The same evaluation instruments and outcome measures that are used for the experimental group will also be used for the control group's monitoring and assessment. Each participant will receive 30 minutes of treatment three days per week for 6 weeks, spread out over four days of the week. Following that, post-test evaluations using MACS, PEDI, GAS, and LEFS will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment It will be Randomized control trial in which non probabilty convenient sampling will be used. Two groups of 7-11 age will be formed in which participants will be randomly divided. Group A will Adapted Physical Activities and group B will only receive conventional Physical Therapy used for hemiplegic cerebral palsy.
| Arm | Type | Receives |
|---|---|---|
| Routine or standard Physical Therapy Group | Active comparator | Other: Routine or standard Physical TherapyThis group will receive routine or conventional physical therapy. |
| Adapted Physical Activity Group | Experimental | Other: Adapted Physical ActivityThis group will receive Adapted Physical Activities. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with hemiplegic cerebral palsy who have been diagnosed fall within the age range of 7 to 11 years.
- GMFCS will be hired at the I-II level.
- Individuals with steady health conditions
Key exclusion criteria (4 listed)
- Diseases or traumas that would make physical therapy inappropriate or dangerous.
- Have previously engaged in a comparable program for adaptive physical activity
- Leave out kids who have recently had Botox injections
- Inability to commit to the study protocol or attend scheduled therapy sessions
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 |
|---|---|---|
| Routine or standard Physical TherapyParticipants will undergo physical therapy to stop abnormal movement patterns and restore control over output in the developmental sequence. Therapists will provide cues to elicit basic posture and movement patterns, inhibiting aberrant patterns. The therapy aims to promote normal posture and movement patterns, incorporating the hemiplegic side for symmetry and functional use. Active usage and targeted strengthening activities will be emphasized, with motor performance practice included. | Other | Routine or standard Physical Therapy Group |
| Adapted Physical ActivityFor Upper extremities, Manual Ability Classification Scale (MACS) is a tool designed to support individuals with hemiplegic cerebral palsy by providing structured support through activities focusing on strength, flexibility, balance, and coordination. Participants at different MACS levels receive tailored treatments, including adaptive tools, task-specific training, assistive gadgets, and functional training. For lower extremities, the therapy will begin on stable support surfaces before progressing to more challenging surfaces such as inflatable cushions, foam pads, or balance discs, focusing on slow and controlled motions for improved body alignment and coordination. | Other | Adapted Physical Activity Group |
Primary outcome
Manual Classification Scale of Ability (MACS)
Time frame: 6 weeks
This tool was created to categorise people with cerebral palsy according to their manual abilities. Based on an individual's self-initiated ability to handle objects, it offers a five-level rating system that emphasises hand use throughout daily activities. Reliability between tests; r = (ICC = 0.984). Mini-MACS and the Gross Motor Function Classification System were found to be correlated (r = 0.626, 0.596, and 0.598)
Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: 6 weeks
Use of the Pediatric Evaluation of Disability Inventory (PEDI): This assessment tool assesses children with impairments' performance and functional abilities. Researchers, therapists, and healthcare professionals frequently utilize the PEDI to evaluate a child's abilities in a variety of daily life domains. ICC = 0.845-0.938, Cronbach's alpha = 0.889-0.964
Goal Attainment Scale (GAS)
Time frame: 6 weeks
An outcome measure intended to evaluate how well people accomplish their objectives over the course of a given intervention or treatment period. It is frequently employed in several industries, such as healthcare, education, and rehabilitation. GAS is a versatile instrument in evaluating progress towards customised targets since it enables the individualization of goal setting and outcome evaluation. Reliability between and within testers (ICC=0.98)
Lower Extremity Functional Scale (LEFS):
Time frame: 6 weeks
Frequently use to evaluate the functional status of patients with musculoskeletal disorders of the lower extremities. It is frequently used to gauge a person's capacity for carrying out different tasks linked to lower limb function in orthopaedic and physical therapy settings. The LEFS often asks about a person's capacity for carrying out routine tasks including running, jumping, walking, and stair climbing. The overall functional status of the lower extremities is assessed using the ratings that respondents provide on a scale for each activity. Intraclass correlation values (ICC=0.85-0.99) and Pearson correlation=(>0.7)
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 30 Oct 2024.
- Background: PubMed 36280232Sit C, Aubert S, Carty C, Silva DAS, Lopez-Gil JF, Asunta P, Palad Y, Guisihan R, Lee J, Arbour Nicitopoulos KP, Vanderloo LM, Stanish H, Haegele J, Urbanski PK, Pozeriene J, Hutzler Y, Ng K. Promoting Physical Activity Among Children and Adolescents With Disabilities: The Translation of Policy to Practice Internationally. J Phys Act Health. 2022 Oct 22;19(11):758-768. doi: 10.1123/jpah.2022-0351. Print 2022 Nov 1.
- 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.
Maryam Mangrio, 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 Routine or standard Physical Therapy and Adapted Physical Activity in people with Hemiplegic 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 3 inclusion and 4 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 30 Oct 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?
Manual Classification Scale of Ability (MACS) (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?
On the ClinicalTrials.gov record for NCT06459505, 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 30 Oct 2024.