Hemiplegic Cerebral PalsyNCT06232330
Effects of TOA Versus PNF Techniques on Trunk Control in Children With Hemiplegic Cerebral Palsy
A study testing Group A and Group B in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy occurs in 2-2.5 per 1000 live births, seems to be the most common cause of lifelong physical disability, and has an impact on the child, caregivers, and society. The incidence of cerebral palsy continues to rise owing to the large numbers of premature and high-risk infants who survive. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Group A and Group B
- Type of treatment
- Medical device
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The level of gross motor function between I and III in accordance with the Gross Motor Function Classification System (GMFCS)
- The degree of spasticity in the affected lower extremity between grade 1 and 1+ in accordance with the Modified Ashworth scale
- 6-12 years of age
- Ability to understand and follow verbal instructions
Who cannot join
- Surgical procedures within the past 6 months
- Botox injection within 6 months
- Unstable Seizures
- Other comorbidity condition (Multiple Disabilities)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Task Oriented Approach Versus Rhythmic Initiation And Stabilization Techniques of PNF on Trunk Control in Children With Hemiplegic Cerebral Palsy
Cerebral palsy occurs in 2-2.5 per 1000 live births, seems to be the most common cause of lifelong physical disability, and has an impact on the child, caregivers, and society. The incidence of cerebral palsy continues to rise owing to the large numbers of premature and high-risk infants who survive. Task-oriented arm approaches promote intensive, meaningful, and goal-oriented training in subjects, and the voluntary functional activities of these subjects possibly reduce their motor disabilities.
Read the detailed description
The study will be randomized clinical trial used to evaluate the effectiveness of TOA and PNF on trunk control in children with hemiplegic cerebral palsy. Subjects with hemiplegic cerebral palsy meeting the inclusion and exclusion criteria will be divided into two groups using non- probability sampling techniques. Assessment will be done using trunk control measuring scale and pediatric reach test . Group A will receive TOA and conventional therapy and Group B will receive PNF and conventional therapy.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Group A, Group B
- Keywords
- CP, Hemiplegia, Rhythmic Initiation, Rhythmic Stabilization, TOA
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ADevice
This group will receive TOA which include Weight transfers from a standing position and stepping in various star-type directions, Sit-ups from different heights with the hemiplegic lower limb behind the normal lower limb, From a kneeling position alternately projecting the lower limb forward, From a standing position with a limited base of support turning head and trunk right to left, Continuous walking on a treadmill for 10 minutes, Ascending and descending of stairs, Crossing 4 obstacles with continuous walking, Walking while simultaneously pushing a stroller, Walking while holding an object, Walking on different surfaces and slopes, The intervention took place for 5 days a week for 6 week for 20 minutes. Pre measurement was taken before the intervention and after 6 weeks post measurement was taken.
Group BDevice
This group will receive PNF techniques for trunk control. Rhythmic initiation and Rhythmic stabilization for a span of 20 minutes on both sides. In rhythmic initiation patient will move passively from trunk flexion into extension and then back to the flexed position When the patient is relaxed and moving easily, ask for active assisted motion Then begin resisting the motion then patient will perform independently in rhythmic stabilization Resist an isometric contraction of the patient's trunk flexor muscles patient will match the resistance in front and then in back
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | TOA and conventional therapy Receives: Device: Group A |
| Group B | Experimental | PNF and conventional therapy Receives: Device: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Control Measuring Scale
The TCMS scale assesses seated trunk control in three dimensions. The maximum score is 58 points where 20 points correspond to static balance, 28 to selective movement control, and 10 to the ability to perform dynamic reaching. The items are scored from 0 to 3, with 0 being the inability to perform the task and 3 being the complete performance of the item.
Measured: 6 weeks
Pediatric Reach Test
It is used to measure the standing balance in normally developed or children with cerebral palsy, that's why is done in standing position. The standing position will be described first and target will be set under the supervision first forward reach will be tested and after this lateral reach will be tested. Reliability of this test is within rater (0.54, 0.88 ICC) and among the rater is (0.50, 0.93ICC)
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 posted30 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 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
- The study will be randomized clinical trial used to evaluate the effect of task-oriented training on balance in spastic hemiplegic cerebral palsied children. Subjects with hemiplegic Cerebral Palsy meeting the inclusion and exclusion criteria will 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
- Ayesha Ijaz, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232330
- Sponsor's protocol ID
- REC/RCR&AHS/23/0738
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salphale VG, Kovela RK, Qureshi MI, Harjpal P. Effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation on Balance and Gait Parameters in Children With Spastic Diplegia. Cureus. 2022 Oct 22;14(10):e30571. doi: 10.7759/cureus.30571. eCollection 2022 Oct.
PubMed 36415346
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 Task Oriented Approach Versus Rhythmic Initiation And Stabilization Techniques of PNF on Trunk Control in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06232330
- Acronym / sponsor ID
- REC/RCR&AHS/23/0738
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- CP, Hemiplegia, Rhythmic Initiation, Rhythmic Stabilization, TOA
- 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
- 30 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 occurs in 2-2.5 per 1000 live births, seems to be the most common cause of lifelong physical disability, and has an impact on the child, caregivers, and society. The incidence of cerebral palsy continues to rise owing to the large numbers of premature and high-risk infants who survive. Task-oriented arm approaches promote intensive, meaningful, and goal-oriented training in subjects, and the voluntary functional activities of these subjects possibly reduce their motor disabilities.
Detailed description
The study will be randomized clinical trial used to evaluate the effectiveness of TOA and PNF on trunk control in children with hemiplegic cerebral palsy. Subjects with hemiplegic cerebral palsy meeting the inclusion and exclusion criteria will be divided into two groups using non- probability sampling techniques. Assessment will be done using trunk control measuring scale and pediatric reach test . Group A will receive TOA and conventional therapy and Group B will receive PNF and conventional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be randomized clinical trial used to evaluate the effect of task-oriented training on balance in spastic hemiplegic cerebral palsied children. Subjects with hemiplegic Cerebral Palsy meeting the inclusion and exclusion criteria will be divided into two groups using non-probability sampling techniques.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Group ATOA and conventional therapy |
| Group B | Experimental | Device: Group BPNF and conventional therapy |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The level of gross motor function between I and III in accordance with the Gross Motor Function Classification System (GMFCS)
- The degree of spasticity in the affected lower extremity between grade 1 and 1+ in accordance with the Modified Ashworth scale
- 6-12 years of age
- Ability to understand and follow verbal instructions
Key exclusion criteria (4 listed)
- Surgical procedures within the past 6 months
- Botox injection within 6 months
- Unstable Seizures
- Other comorbidity condition (Multiple Disabilities)
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 |
|---|---|---|
| Group AThis group will receive TOA which include Weight transfers from a standing position and stepping in various star-type directions, Sit-ups from different heights with the hemiplegic lower limb behind the normal lower limb, From a kneeling position alternately projecting the lower limb forward, From a standing position with a limited base of support turning head and trunk right to left, Continuous walking on a treadmill for 10 minutes, Ascending and descending of stairs, Crossing 4 obstacles with continuous walking, Walking while simultaneously pushing a stroller, Walking while holding an object, Walking on different surfaces and slopes, The intervention took place for 5 days a week for 6 week for 20 minutes. Pre measurement was taken before the intervention and after 6 weeks post measurement was taken. | Device | Group A |
| Group BThis group will receive PNF techniques for trunk control. Rhythmic initiation and Rhythmic stabilization for a span of 20 minutes on both sides. In rhythmic initiation patient will move passively from trunk flexion into extension and then back to the flexed position When the patient is relaxed and moving easily, ask for active assisted motion Then begin resisting the motion then patient will perform independently in rhythmic stabilization Resist an isometric contraction of the patient's trunk flexor muscles patient will match the resistance in front and then in back | Device | Group B |
Primary outcome
Trunk Control Measuring Scale
Time frame: 6 weeks
The TCMS scale assesses seated trunk control in three dimensions. The maximum score is 58 points where 20 points correspond to static balance, 28 to selective movement control, and 10 to the ability to perform dynamic reaching. The items are scored from 0 to 3, with 0 being the inability to perform the task and 3 being the complete performance of the item.
Pediatric Reach Test
Time frame: 6 weeks
It is used to measure the standing balance in normally developed or children with cerebral palsy, that's why is done in standing position. The standing position will be described first and target will be set under the supervision first forward reach will be tested and after this lateral reach will be tested. Reliability of this test is within rater (0.54, 0.88 ICC) and among the rater is (0.50, 0.93ICC)
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 36415346Salphale VG, Kovela RK, Qureshi MI, Harjpal P. Effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation on Balance and Gait Parameters in Children With Spastic Diplegia. Cureus. 2022 Oct 22;14(10):e30571. doi: 10.7759/cureus.30571. eCollection 2022 Oct.
- 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.
Ayesha Ijaz, 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 Group A and Group B 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 4 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 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?
Trunk Control Measuring Scale (time frame: 6 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 NCT06232330, 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.