Cerebral PalsyNCT04937439
Segmental Trunk Stability Training on Sitting and Upper Limbs Functions in Children With Spastic Cerebral Palsy
A study testing Traditional Physical Therapy program, Segmental trunk training A and Segmental trunk training B in people with Cerebral Palsy, run by Horus University at 1 site in Egypt.
Trial summary
The study aims to: 1. Investigate the effect of segmental trunk stability training on sitting in children with spastic CP. 2. Investigate the effect of segmental trunk stability training on upper limbs functions in children with spastic CP. Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Traditional Physical Therapy program, Segmental trunk training A and Segmental trunk training B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Jan 2022
- 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 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with spastic CP, their chronological age will be ranged from 2 years to 4 years.
- Their level of motor function will be 4 or 5 according to Gross Motor Function Classification System - Expanded and Revised
- The degree of spasticity for these children will ranged from grade 1 to 2 according to Modified Ashworth Scale
- All children's level of segmental trunk control will be level 3 according to Segmental Assessment of Trunk Control
- They will be able to follow instructions during evaluation and treatment.
Who cannot join
- Any child with the following criteria will be directly excluded from the evaluation for the consistency of the sample and statistically obtained results: 1. Surgical interference in upper limbs and/or spine that may restrain the child performance during activities.2. Orthopedic problems or fixed deformities in the vertebral column and/or upper extremities. 3. Uncontrolled seizures. 4. Visual or hearing impairment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic, faculty of Physical Therapy, Horus University, Egypt
Damietta
Mohamed Arafat, +201222683664, marafat@horus.edu.eg
About this study
Official title: Effect of Segmental Trunk Stability Training on Sitting and Upper Limbs Functions in Children With Spastic Cerebral Palsy
The study aims to:
- Investigate the effect of segmental trunk stability training on sitting in children with spastic CP.
- Investigate the effect of segmental trunk stability training on upper limbs functions in children with spastic CP.
Read the detailed description
Postural dysfunction is one of the most limiting factors in children with CP. It restricts reaching skills and in turn reduces participation in activities of daily living.
The trunk plays a key role in maintaining the postural control mechanism and also in the organization of balance reactions in this developmental process. The trunk control is also required for a stable base of support which is necessary to execute functional activities for limb movements.
The optimal level of trunk support for a child with spastic CP still remains unknown. Thus, providing intermediate levels of trunk stabilization would be a better solution than providing full support in children with CP. Innovation is necessary to improve outcomes for children with moderate to- severe CP who are at level IV and V on GMFCS. However, these children are often excluded from posture research . Very little research has examined postural constraints in children with moderate-to-severe CP.
As there is a lack of tools used in precise trunk stabilization during training, a further researches are needed. Recently, a special attention has been given to the segmental trunk control and its effects on improvement of gross and fine motor skills. Most of previous studies have been applied during segmental fixation of the trunk at multiple levels from static position either sitting or standing. In the present study, the effect of external segmental stabilization of the trunk at selected parts will be monitored during the active training and participation of the child.
- Conditions
- Cerebral Palsy
- Being tested
- Traditional Physical Therapy program, Segmental trunk training A, Segmental trunk training B, Segmental trunk training C
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Physical Therapy programOther
- Facilitation of head control will be conducted.
- Facilitation of trunk control will be applied
- Facilitation of rolling
- Facilitation of righting, protective and equilibrium reactions from supine, prone and sitting on a ball
- Stretching exercises for the muscles liable to be tight
- Facilitation of sitting
Segmental trunk training AOther
Group (A) will wear an external segmental trunk support extended from the level of pelvis to a level just below the rib cage.
Segmental trunk training BOther
Group (B) will receive the same program given to (group A) while wearing an external segmental trunk support extended from the level of pelvis to a level just below the inferior angle of scapula.
Segmental trunk training COther
Group (C) will receive the same program given to (group A and B) while wearing an external segmental trunk support extended from the level of last rib to the level of the inferior angle of scapula.
| Study group | Role | What they receive |
|---|---|---|
| Segmental trunk training A | Experimental | Children in this group will receive specially designed physical therapy program while wearing a segmental trunk support from the level of pelvis to a level just below the rib cage. Receives: Other: Traditional Physical Therapy program; Other: Segmental trunk training A |
| Segmental trunk training B | Active comparator | Children in this group will receive the same program given to (group A) while wearing a segmental trunk support from the level of pelvis to a level just below the inferior angle of scapula. Receives: Other: Traditional Physical Therapy program; Other: Segmental trunk training B |
| Segmental trunk training C | Active comparator | will receive the same program given to (group A and B) while wearing a segmental trunk support from the level of last rib to the level of the inferior angle of scapula. Receives: Other: Traditional Physical Therapy program; Other: Segmental trunk training C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in gross motor function - sitting domain
Assessment via using gross motor functional measurement scale is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy.
Measured: Baseline and after 6 months post intervention
Assessing the change in segmental trunk control
Assessment via using Segmental Assessment of Trunk Control (SATCo) is a validated and internationally recognized measurement tool.
Measured: Baseline and after 6 months post intervention
Assessing the change in upper limb functions
Assessment via using Quality of Upper Extremity Skills Test (QUEST) is a 34-item observational criterion-referenced test consisting of four subsections: dissociated movement, grasp, weight bearing, and protective extension. Items are related to quality of movement, not to chronological age.
Measured: Baseline and after 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Jan 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Arafat, Horus University
- Investigators
- Mohamed Arafat, Assistant Lecturer, Principal investigator, Horus University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937439
- Sponsor's protocol ID
- Arafat_phd
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Segmental Trunk Stability Training on Sitting and Upper Limbs Functions in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04937439
- Acronym / sponsor ID
- Arafat_phd
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 24 Jun 2021 (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 study aims to:
- Investigate the effect of segmental trunk stability training on sitting in children with spastic CP.
- Investigate the effect of segmental trunk stability training on upper limbs functions in children with spastic CP.
Detailed description
Postural dysfunction is one of the most limiting factors in children with CP. It restricts reaching skills and in turn reduces participation in activities of daily living.
The trunk plays a key role in maintaining the postural control mechanism and also in the organization of balance reactions in this developmental process. The trunk control is also required for a stable base of support which is necessary to execute functional activities for limb movements.
The optimal level of trunk support for a child with spastic CP still remains unknown. Thus, providing intermediate levels of trunk stabilization would be a better solution than providing full support in children with CP. Innovation is necessary to improve outcomes for children with moderate to- severe CP who are at level IV and V on GMFCS. However, these children are often excluded from posture research . Very little research has examined postural constraints in children with moderate-to-severe CP.
As there is a lack of tools used in precise trunk stabilization during training, a further researches are needed. Recently, a special attention has been given to the segmental trunk control and its effects on improvement of gross and fine motor skills. Most of previous studies have been applied during segmental fixation of the trunk at multiple levels from static position either sitting or standing. In the present study, the effect of external segmental stabilization of the trunk at selected parts will be monitored during the active training and participation of the child.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Segmental trunk training A | Experimental | Other: Traditional Physical Therapy program, Other: Segmental trunk training AChildren in this group will receive specially designed physical therapy program while wearing a segmental trunk support from the level of pelvis to a level just below the rib cage. |
| Segmental trunk training B | Active comparator | Other: Traditional Physical Therapy program, Other: Segmental trunk training BChildren in this group will receive the same program given to (group A) while wearing a segmental trunk support from the level of pelvis to a level just below the inferior angle of scapula. |
| Segmental trunk training C | Active comparator | Other: Traditional Physical Therapy program, Other: Segmental trunk training Cwill receive the same program given to (group A and B) while wearing a segmental trunk support from the level of last rib to the level of the inferior angle of scapula. |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with spastic CP, their chronological age will be ranged from 2 years to 4 years.
- Their level of motor function will be 4 or 5 according to Gross Motor Function Classification System - Expanded and Revised
- The degree of spasticity for these children will ranged from grade 1 to 2 according to Modified Ashworth Scale
- All children's level of segmental trunk control will be level 3 according to Segmental Assessment of Trunk Control
- They will be able to follow instructions during evaluation and treatment.
Key exclusion criteria (1 listed)
- Any child with the following criteria will be directly excluded from the evaluation for the consistency of the sample and statistically obtained results: 1. Surgical interference in upper limbs and/or spine that may restrain the child performance during activities.2. Orthopedic problems or fixed deformities in the vertebral column and/or upper extremities. 3. Uncontrolled seizures. 4. Visual or hearing impairment.
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 |
|---|---|---|
| Traditional Physical Therapy program1. Facilitation of head control will be conducted. 2. Facilitation of trunk control will be applied 3. Facilitation of rolling 4. Facilitation of righting, protective and equilibrium reactions from supine, prone and sitting on a ball 5. Stretching exercises for the muscles liable to be tight 6. Facilitation of sitting | Other | Segmental trunk training A, Segmental trunk training B, Segmental trunk training C |
| Segmental trunk training AGroup (A) will wear an external segmental trunk support extended from the level of pelvis to a level just below the rib cage. | Other | Segmental trunk training A |
| Segmental trunk training BGroup (B) will receive the same program given to (group A) while wearing an external segmental trunk support extended from the level of pelvis to a level just below the inferior angle of scapula. | Other | Segmental trunk training B |
| Segmental trunk training CGroup (C) will receive the same program given to (group A and B) while wearing an external segmental trunk support extended from the level of last rib to the level of the inferior angle of scapula. | Other | Segmental trunk training C |
Primary outcome
Assessing the change in gross motor function - sitting domain
Time frame: Baseline and after 6 months post intervention
Assessment via using gross motor functional measurement scale is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy.
Assessing the change in segmental trunk control
Time frame: Baseline and after 6 months post intervention
Assessment via using Segmental Assessment of Trunk Control (SATCo) is a validated and internationally recognized measurement tool.
Assessing the change in upper limb functions
Time frame: Baseline and after 6 months post intervention
Assessment via using Quality of Upper Extremity Skills Test (QUEST) is a 34-item observational criterion-referenced test consisting of four subsections: dissociated movement, grasp, weight bearing, and protective extension. Items are related to quality of movement, not to chronological age.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- 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.
Mohamed Arafat, Assistant Lecturer principal investigator
Horus University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Physical Therapy program, Segmental trunk training A and Segmental trunk training B in people with Cerebral Palsy, run by Horus University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 24 Jun 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Arafat, MSc (+201222683664, marafat@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in gross motor function - sitting domain (time frame: Baseline and after 6 months post intervention). 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?
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 24 Jun 2021.