Cerebral PalsyNCT06504550
Comparison Between Schroth and Klapp Method in CP Children With Scoliosis
A study testing Schroth Exercises and Klapp Exercises in people with Cerebral Palsy and Scoliosis, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy, which occurs in two to three out of 1,000 live births, has multiple etiologies resulting in brain injury that affects movement, posture, and balance. Approximately one-third of children with CP are non-ambulant and subsequently spend prolonged periods of time in sitting or lying. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cerebral Palsy, Scoliosis
- What is being tested?
- Schroth Exercises and Klapp Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 14 May 2024to 28 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8 to 12 years of age
- Either gender.
- The level of gross motor function between levels I and II in accordance with the gross motor function classification system (GMFCS) .
- Angle of Trunk Rotation (ATR) > 4 degree .
- Ability to understand and follow verbal instructions
Who cannot join
- Patients will be excluded if they have had been prescribed brace treatment
- Has received any previous corrective or surgical treatment of the spine
- Unable to participate, or are reluctant to receive treatment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Comparison Between Schroth AND Klapp Method On Postural Stability AND Trunk Rotation Angle In CP Children With Scoliosis
Cerebral palsy, which occurs in two to three out of 1,000 live births, has multiple etiologies resulting in brain injury that affects movement, posture, and balance. Approximately one-third of children with CP are non-ambulant and subsequently spend prolonged periods of time in sitting or lying. Non-ambulatory patients with cerebral palsy (CP) bear a high risk of developing simultaneous progressive scoliotic spine deformities, loss of sitting balance and hip subluxation/dislocation.Treatments for the Spinal deformities associated with cerebral palsy are Schroth method. It is a scoliosis-specific exercise approach that uses postural, scoliosis-specific sensorimotor exercises. While another treatment approach Klapp method aimed to stretch and strengthen muscles by all fours positions, easily applied and that can be used in small groups.
A Randomized clinical trial will be conducted through convenient sampling. Inclusion criteria of this study is age between 8 to 12 years of either gender, with GMFCS level I and II and Trunk rotation angle (ATR) > 4 degree, who are able to understand and follow verbal instructions. Those patients who has been prescribed brace treatment, has scheduled or undergone any corrective surgical treatment of the spine before or during data collection process will be excluded. Patients who are unable to participate, or are reluctant to receive treatment are excluded. Study will be conducted on 22 patients who will be randomly allocated into two groups. One group will receive Schroth exercises. It consists of passive and active postural auto-correction exercises done repeatedly and based on kinesthetic and sensorimotor principles. While the other group with Klapp method includes stretching and strengthening muscles by all fours positions. Bunnell's scoliometer, Adams forward bend test, and Posture and postural ability scale (PPAS) will be used as outcome measure.
Read the detailed description
Group A is Schroth Group (SG). The patients in the Schroth exercise group will start their exercise program under physiotherapist supervision. Exercise treatment program will consist of 18 sessions, 30 minutes each session, three times a week, for 6 weeks. Schroth exercises will be performed in an asymmetric position to maximize correction to achieve trunk symmetry. These exercises include spinal elongation, de-rotation, de-flexion, stretching, strengthening and rotational breathing exercises to maintain vertebral alignment. The participants will be asked to combine these exercises with their daily living activities (ADLs). During the Schroth exercises, rice bags, foam blocks, a stool, and long sticks will be used to adjust the posture and give passive support. Exercises are progressed from lying, sitting, or standing positions and from most to least passive support per a review of the quality of the performance. Decreasing the amount or degree of passive support, changing the patient's position, and adjusting the sets and repetitions of exercises will depend on the patient's improvement in exercise performance Group B is Klapp group (KG).The patients in the Klapp exercise group will be treated with supervised klapp exercises. Exercise treatment program will consist of 18 sessions, 30 minutes each session, three times a week, for 6 weeks. In each session, a sequence of 8 postures of Klapp Exercises will be carried out. Each posture will be maintained for 4-5 minutes with rest breaks when needed. Positions that will be held are: 1) Lateral crawl, 2) Horizontal sliding, 3) Crawl posture near the ground, 4) Bunny hopping, 5) Arm turn, 6) Big arch, 7) Lateral crawl near the ground, 8) Big curve
- Conditions
- Cerebral Palsy, Scoliosis
- Being tested
- Schroth Exercises, Klapp Exercises
- Keywords
- Cerebral Palsy, Klapp, Postural Stability, Schroth, Scoliosis, Trunk Rotation Angle
- Medical subject headings
- Cerebral Palsy, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schroth ExercisesOther
The patients in the Schroth exercise group will start their exercise program under physiotherapist supervision.Exercise treatment program will consist of 18 sessions, 30 minutes each session, three times a week, for 6 weeks.These exercises include spinal elongation, de-rotation, de-flexion, stretching, strengthening exercises to maintain vertebral alignment.The participants will be asked to combine these exercises with their daily living activities (ADLs).During the Schroth exercises, rice bags, foam blocks, a stool, and long sticks will be used to adjust the posture and give passive support.Exercises are progressed from lying, sitting, or standing positions and from most to least passive support per a review of the quality of the performance.Decreasing the amount or degree of passive support, changing the patient's position, and adjusting the sets and repetitions of exercises will depend on the patient's improvement in exercise performance
Klapp ExercisesOther
The patients in the Klapp exercise group will be treated with supervised klapp exercises. Exercise treatment program will consist of 18 sessions, 30 minutes each session, three times a week, for 6 weeks.In each session, a sequence of 8 postures of Klapp Exercises will be carried out. Each posture will be maintained for 4-5 minutes with rest breaks when needed.Positions that will be held are: 1) Lateral crawl, 2) Horizontal sliding, 3) Crawl posture near the ground, 4) Bunny hopping, 5) Arm turn, 6) Big arch, 7) Lateral crawl near the ground, 8) Big curve
| Study group | Role | What they receive |
|---|---|---|
| Schroth Exercise. Group A receive Schroth Exercises. | Experimental | Group A: Schroth Group (SG). The patients in the Schroth exercise group will start their exercise program under physiotherapist supervision. Exercise treatment program will consist of 18 sessions, 30 minutes each session, three times a week, for 6 weeks. These exercises include spinal elongation, de-rotation, de-flexion, stretching, strengthening to maintain vertebral alignment.The participants will be asked to combine these exercises with their daily living activities (ADLs).During the Schroth exercises, rice bags, foam blocks, a stool, and long sticks will be used to adjust the posture and give passive support.Exercises are progressed from lying, sitting, or standing positions and from most to least passive support per a review of the quality of the performance.Decreasing the amount or degree of passive support, changing the patient's position, and adjusting the sets and repetitions of exercises will depend on the patient's improvement in exercise performance Receives: Other: Schroth Exercises |
| Klapp Exercise. Group B receive Klapp Exercises. | Experimental | Group B: Klapp group (KG). The patients in the Klapp exercise group will be treated with supervised klapp exercises.Exercise treatment program will consist of 18 sessions, 30 minutes each session, three times a week, for 6 weeks.In each session, a sequence of 8 postures of Klapp Exercises will be carried out.Each posture will be maintained for 4-5 minutes with rest breaks when needed.Positions that will be held are: 1) Lateral crawl, 2) Horizontal sliding, 3) Crawl posture near the ground, 4) Bunny hopping, 5) Arm turn, 6) Big arch, 7) Lateral crawl near the ground, 8) Big curve Receives: Other: Klapp Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posture and Postural Ability Scale (PPAS)
An assessment tool for measuring the quality of postures as well as classifying the ability to maintain and manipulate postures.The Posture and Postural Ability Scale (PPAS) is used to assess supine, prone, lying and sitting posture in the frontal and sagittal planes. The scale ranges from full symmetry to total asymmetry. Similarly, their ability to change or maintain position was rated according to the levels of PPAS ranging from "Able to move into and out of position independently" (level 7) to "Unplaceable in an aligned position" (level 1).The PPAS has excellent inter-rater reliability and validity for children and adults with CP
Measured: 6 weeks
Bunnell's Scoliometer
Trunk rotation angle (ATR) will be evaluated using Bunnell's scoliometer and Adam's forward bend test. For patients with scoliosis, a landmark for measuring the angle of trunk rotation will be marked on the protruding area during the forward bending test using a scoliometer. For measuring the angle of trunk rotation of scoliosis patient, in order to set the reference point of the scoliometer, the scoliometer is placed on the floor and focused. In the forward bending test, the angle of trunk rotation is measured using a scoliometer on the area to be measured marked with a sticker. The measured value will be read and recorded. The inter-rater reliability according to the measurement method with Scoliometer measurement method 0.971. The scoliometer measurement method has the highest validity (r=0.976)
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 posted16 Jul 2024
- Study start14 May 2024
- Primary completion21 Jul 2024
- Study completion28 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.
- 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 clinical trial in which non probability convinient sampling will be used.Two groups of 8 to 12 years of age will be formed in which participants will be randomly divided.In Group A Schroth exercises will be conducted that consist of passive and active postural auto-correction exercises done repeatedly and based on kinesthetic and sensorimotor principles.In Group B Klapp group will be treated with klapp exercises. In each session, a sequence of 8 postures of Klapp method will be carried out
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Khaliq, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504550
- Sponsor's protocol ID
- REC/RCR&AHS/23/0779
- Status last verified
- Aug 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agustsson A, Sveinsson T, Pope P, Rodby-Bousquet E. Preferred posture in lying and its association with scoliosis and windswept hips in adults with cerebral palsy. Disabil Rehabil. 2019 Dec;41(26):3198-3202. doi: 10.1080/09638288.2018.1492032. Epub 2018 Jul 16.
PubMed 30010440
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Schroth AND Klapp Method On Postural Stability AND Trunk Rotation Angle In CP Children With Scoliosis
- ClinicalTrials.gov ID
- NCT06504550
- Acronym / sponsor ID
- REC/RCR&AHS/23/0779
- Conditions
- Cerebral Palsy, Scoliosis
- Keywords
- Cerebral Palsy, Klapp, Postural Stability, Schroth, Scoliosis, Trunk Rotation Angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 21 Jul 2024 (actual)
- Study completion
- 28 Jul 2024 (actual)
- First posted
- 16 Jul 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, which occurs in two to three out of 1,000 live births, has multiple etiologies resulting in brain injury that affects movement, posture, and balance. Approximately one-third of children with CP are non-ambulant and subsequently spend prolonged periods of time in sitting or lying. Non-ambulatory patients with cerebral palsy (CP) bear a high risk of developing simultaneous progressive scoliotic spine deformities, loss of sitting balance and hip subluxation/dislocation.Treatments for the Spinal deformities associated with cerebral palsy are Schroth method. It is a scoliosis-specific exercise approach that uses postural, scoliosis-specific sensorimotor exercises. While another treatment approach Klapp method aimed to stretch and strengthen muscles by all fours positions, easily applied and that can be used in small groups.
A Randomized clinical trial will be conducted through convenient sampling. Inclusion criteria of this study is age between 8 to 12 years of either gender, with GMFCS level I and II and Trunk rotation angle (ATR) > 4 degree, who are able to understand and follow verbal instructions. Those patients who has been prescribed brace treatment, has scheduled or undergone any corrective surgical treatment of the spine before or during data collection process will be excluded. Patients who are unable to participate, or are reluctant to receive treatment are excluded. Study will be conducted on 22 patients who will be randomly allocated into two groups. One group will receive Schroth exercises. It consists of passive and active postural auto-correction exercises done repeatedly and based on kinesthetic and sensorimotor principles. While the other group with Klapp method includes stretching and strengthening muscles by all fours positions. Bunnell's scoliometer, Adams forward bend test, and Posture and postural ability scale (PPAS) will be used as outcome measure.
Detailed description
Group A is Schroth Group (SG). The patients in the Schroth exercise group will start their exercise program under physiotherapist supervision. Exercise treatment program will consist of 18 sessions, 30 minutes each session, three times a week, for 6 weeks. Schroth exercises will be performed in an asymmetric position to maximize correction to achieve trunk symmetry. These exercises include spinal elongation, de-rotation, de-flexion, stretching, strengthening and rotational breathing exercises to maintain vertebral alignment. The participants will be asked to combine these exercises with their daily living activities (ADLs). During the Schroth exercises, rice bags, foam blocks, a stool, and long sticks will be used to adjust the posture and give passive support. Exercises are progressed from lying, sitting, or standing positions and from most to least passive support per a review of the quality of the performance. Decreasing the amount or degree of passive support, changing the patient's position, and adjusting the sets and repetitions of exercises will depend on the patient's improvement in exercise performance Group B is Klapp group (KG).The patients in the Klapp exercise group will be treated with supervised klapp exercises. Exercise treatment program will consist of 18 sessions, 30 minutes each session, three times a week, for 6 weeks. In each session, a sequence of 8 postures of Klapp Exercises will be carried out. Each posture will be maintained for 4-5 minutes with rest breaks when needed. Positions that will be held are: 1) Lateral crawl, 2) Horizontal sliding, 3) Crawl posture near the ground, 4) Bunny hopping, 5) Arm turn, 6) Big arch, 7) Lateral crawl near the ground, 8) Big curve
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 clinical trial in which non probability convinient sampling will be used.Two groups of 8 to 12 years of age will be formed in which participants will be randomly divided.In Group A Schroth exercises will be conducted that consist of passive and active postural auto-correction exercises done repeatedly and based on kinesthetic and sensorimotor principles.In Group B Klapp group will be treated with klapp exercises. In each session, a sequence of 8 postures of Klapp method will be carried out
| Arm | Type | Receives |
|---|---|---|
| Schroth Exercise. Group A receive Schroth Exercises. | Experimental | Other: Schroth ExercisesGroup A: Schroth Group (SG). The patients in the Schroth exercise group will start their exercise program under physiotherapist supervision. Exercise treatment program will consist of 18 sessions, 30 minutes each session, three times a week, for 6 weeks. These exercises include spinal elongation, de-rotation, de-flexion, stretching, strengthening to maintain vertebral alignment.The participants will be asked to combine these exercises with their daily living activities (ADLs).During the Schroth exercises, rice bags, foam blocks, a stool, and long sticks will be used to adjust the posture and give passive support.Exercises are progressed from lying, sitting, or standing positions and from most to least passive support per a review of the quality of the performance.Decreasing the amount or degree of passive support, changing the patient's position, and adjusting the sets and repetitions of exercises will depend on the patient's improvement in exercise performance |
| Klapp Exercise. Group B receive Klapp Exercises. | Experimental | Other: Klapp ExercisesGroup B: Klapp group (KG). The patients in the Klapp exercise group will be treated with supervised klapp exercises.Exercise treatment program will consist of 18 sessions, 30 minutes each session, three times a week, for 6 weeks.In each session, a sequence of 8 postures of Klapp Exercises will be carried out.Each posture will be maintained for 4-5 minutes with rest breaks when needed.Positions that will be held are: 1) Lateral crawl, 2) Horizontal sliding, 3) Crawl posture near the ground, 4) Bunny hopping, 5) Arm turn, 6) Big arch, 7) Lateral crawl near the ground, 8) Big curve |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 8 to 12 years of age
- Either gender.
- The level of gross motor function between levels I and II in accordance with the gross motor function classification system (GMFCS) .
- Angle of Trunk Rotation (ATR) > 4 degree .
- Ability to understand and follow verbal instructions
Key exclusion criteria (3 listed)
- Patients will be excluded if they have had been prescribed brace treatment
- Has received any previous corrective or surgical treatment of the spine
- Unable to participate, or are reluctant to receive treatment
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 |
|---|---|---|
| Schroth ExercisesThe patients in the Schroth exercise group will start their exercise program under physiotherapist supervision.Exercise treatment program will consist of 18 sessions, 30 minutes each session, three times a week, for 6 weeks.These exercises include spinal elongation, de-rotation, de-flexion, stretching, strengthening exercises to maintain vertebral alignment.The participants will be asked to combine these exercises with their daily living activities (ADLs).During the Schroth exercises, rice bags, foam blocks, a stool, and long sticks will be used to adjust the posture and give passive support.Exercises are progressed from lying, sitting, or standing positions and from most to least passive support per a review of the quality of the performance.Decreasing the amount or degree of passive support, changing the patient's position, and adjusting the sets and repetitions of exercises will depend on the patient's improvement in exercise performance | Other | Schroth Exercise. Group A receive Schroth Exercises. |
| Klapp ExercisesThe patients in the Klapp exercise group will be treated with supervised klapp exercises. Exercise treatment program will consist of 18 sessions, 30 minutes each session, three times a week, for 6 weeks.In each session, a sequence of 8 postures of Klapp Exercises will be carried out. Each posture will be maintained for 4-5 minutes with rest breaks when needed.Positions that will be held are: 1) Lateral crawl, 2) Horizontal sliding, 3) Crawl posture near the ground, 4) Bunny hopping, 5) Arm turn, 6) Big arch, 7) Lateral crawl near the ground, 8) Big curve | Other | Klapp Exercise. Group B receive Klapp Exercises. |
Primary outcome
Posture and Postural Ability Scale (PPAS)
Time frame: 6 weeks
An assessment tool for measuring the quality of postures as well as classifying the ability to maintain and manipulate postures.The Posture and Postural Ability Scale (PPAS) is used to assess supine, prone, lying and sitting posture in the frontal and sagittal planes. The scale ranges from full symmetry to total asymmetry. Similarly, their ability to change or maintain position was rated according to the levels of PPAS ranging from "Able to move into and out of position independently" (level 7) to "Unplaceable in an aligned position" (level 1).The PPAS has excellent inter-rater reliability and validity for children and adults with CP
Bunnell's Scoliometer
Time frame: 6 weeks
Trunk rotation angle (ATR) will be evaluated using Bunnell's scoliometer and Adam's forward bend test. For patients with scoliosis, a landmark for measuring the angle of trunk rotation will be marked on the protruding area during the forward bending test using a scoliometer. For measuring the angle of trunk rotation of scoliosis patient, in order to set the reference point of the scoliometer, the scoliometer is placed on the floor and focused. In the forward bending test, the angle of trunk rotation is measured using a scoliometer on the area to be measured marked with a sticker. The measured value will be read and recorded. The inter-rater reliability according to the measurement method with Scoliometer measurement method 0.971. The scoliometer measurement method has the highest validity (r=0.976)
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 14 Aug 2024.
- Background: PubMed 30010440Agustsson A, Sveinsson T, Pope P, Rodby-Bousquet E. Preferred posture in lying and its association with scoliosis and windswept hips in adults with cerebral palsy. Disabil Rehabil. 2019 Dec;41(26):3198-3202. doi: 10.1080/09638288.2018.1492032. Epub 2018 Jul 16.
- 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 Khaliq, 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 Schroth Exercises and Klapp Exercises in people with Cerebral Palsy and Scoliosis, 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 5 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 14 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?
Posture and Postural Ability Scale (PPAS) (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 NCT06504550, 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 14 Aug 2024.