Cerebral PalsyNCT04246645
Effect of Core Stability Exercises on Hand Functions in Children With Hemiparesis
A study testing CORE STABILITY EXERCISES in people with Cerebral Palsy, run by hanaa mohsen at 1 site in Egypt.
Trial summary
Background: Impaired upper extremity is the major disability facing the children with hemiplegia as the inability to use hands for reach; grasp and manipulation affect their daily life activities. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- CORE STABILITY EXERCISES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2020to 31 Mar 2020
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The level of gross motor function ranged from II to III, according to Gross Motor Function Classification System
- All participants are cognitively capable and competent of interpreting and following instructions
Who cannot join
- if they had fixed contractures or deformities of the spine, upper or lower extremities,
- visual or respiratory disorders, orthopedic surgery on their involved upper extremity;
- dorsal rhizotomy;
- botulinum toxin therapy in the upper extremity musculature during the past 6 months
- who wished to receive it within the period of study
Trial locations and contacts
1 site in 1 country.
About this study
Background: Impaired upper extremity is the major disability facing the children with hemiplegia as the inability to use hands for reach; grasp and manipulation affect their daily life activities. little attention has been given to gain perspective about abnormal movements that are detectable in hemiplegic cerebral palsy that are related to one's level of core stability and how they affect their hand functions.
Read the detailed description
Background: Impaired upper extremity is the major disability facing the children with hemiplegia as the inability to use hands for reach; grasp and manipulation affect their daily life activities. little attention has been given to gain perspective about abnormal movements that are detectable in hemiplegic cerebral palsy that are related to one's level of core stability and how they affect their hand functions.
Objective: The purpose was to investigate the effectivness of core stability exercises on hand functions in hemiplegic cerebral palsy.
Methods: Thirty hemiparetic cerebral palsied children of both sexes, ranged in age from 6 to 8 years enrolled in this study. They randomly assigned into two groups of equal number. Group (A) received the selective physiotherapy exercises and group (B) received the same selective physiotherapy exercises program in addition to core stability exercises three times/week for 60 min for 12 weeks. Time motor performance, gross manual dexterity and skills of the upper extremity were assessed by using Jebsen Taylor Test (JTHFT), Box and Block Test (BBT) and Quality Upper Extremity Skill Test (QUEST) respectively before and after treatment.
- Conditions
- Cerebral Palsy
- Being tested
- CORE STABILITY EXERCISES
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORE STABILITY EXERCISESOther
SELECTED CORE EXERCISES
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | No intervention | received the selective physiotherapy exercises |
| STUDY GROUP | Experimental | received the same selective physiotherapy exercises program in addition to core stability exercises three times/week for 60 min for 12 weeks Receives: Other: CORE STABILITY EXERCISES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jebsen Taylor Test
scale used to asses gross manual dexterity
Measured: Jebsen Taylor Test used to assess gross manual dexterity before the intervention and after three months of the intervention . the loweest score indicate improvement
Secondary outcomes (2)
Box and Block Test
scale used to asses gross manual dexterity
Measured: Box and Block Test used to asses gross manual dexterity pre and after 3 months of intervension
Quality Upper Extremity Skill Test
scale used to asses skills of the upper extremity
Measured: Quality Upper Extremity Skill Test scale used to asses skills of the upper extremity pre and after 3 months of intervension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start22 Jan 2020
- Primary completion20 Mar 2020
- Study completion31 Mar 2020
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- hanaa mohsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, hanaa mohsen, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246645
- Sponsor's protocol ID
- Hana 2
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2020
- Last updated
- 28 Jan 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 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Stability Exercises on Hand Functions in Children With Hemiparesis
- ClinicalTrials.gov ID
- NCT04246645
- Acronym / sponsor ID
- Hana 2
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- hanaa mohsenUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 29 Jan 2020 (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.
Background: Impaired upper extremity is the major disability facing the children with hemiplegia as the inability to use hands for reach; grasp and manipulation affect their daily life activities. little attention has been given to gain perspective about abnormal movements that are detectable in hemiplegic cerebral palsy that are related to one's level of core stability and how they affect their hand functions.
Detailed description
Background: Impaired upper extremity is the major disability facing the children with hemiplegia as the inability to use hands for reach; grasp and manipulation affect their daily life activities. little attention has been given to gain perspective about abnormal movements that are detectable in hemiplegic cerebral palsy that are related to one's level of core stability and how they affect their hand functions.
Objective: The purpose was to investigate the effectivness of core stability exercises on hand functions in hemiplegic cerebral palsy.
Methods: Thirty hemiparetic cerebral palsied children of both sexes, ranged in age from 6 to 8 years enrolled in this study. They randomly assigned into two groups of equal number. Group (A) received the selective physiotherapy exercises and group (B) received the same selective physiotherapy exercises program in addition to core stability exercises three times/week for 60 min for 12 weeks. Time motor performance, gross manual dexterity and skills of the upper extremity were assessed by using Jebsen Taylor Test (JTHFT), Box and Block Test (BBT) and Quality Upper Extremity Skill Test (QUEST) respectively before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | No intervention | –received the selective physiotherapy exercises |
| STUDY GROUP | Experimental | Other: CORE STABILITY EXERCISESreceived the same selective physiotherapy exercises program in addition to core stability exercises three times/week for 60 min for 12 weeks |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The level of gross motor function ranged from II to III, according to Gross Motor Function Classification System
- All participants are cognitively capable and competent of interpreting and following instructions
Key exclusion criteria (5 listed)
- if they had fixed contractures or deformities of the spine, upper or lower extremities,
- visual or respiratory disorders, orthopedic surgery on their involved upper extremity;
- dorsal rhizotomy;
- botulinum toxin therapy in the upper extremity musculature during the past 6 months
- who wished to receive it within the period of study
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 |
|---|---|---|
| CORE STABILITY EXERCISESSELECTED CORE EXERCISES | Other | STUDY GROUP |
Primary outcome
Jebsen Taylor Test
Time frame: Jebsen Taylor Test used to assess gross manual dexterity before the intervention and after three months of the intervention . the loweest score indicate improvement
scale used to asses gross manual dexterity
2 secondary outcomes
Box and Block Test
Time frame: Box and Block Test used to asses gross manual dexterity pre and after 3 months of intervension
Quality Upper Extremity Skill Test
Time frame: Quality Upper Extremity Skill Test scale used to asses skills of the upper extremity pre and after 3 months of intervension
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 28 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CORE STABILITY EXERCISES in people with Cerebral Palsy, run by hanaa mohsen 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 2 inclusion and 5 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 28 Jan 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?
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?
Jebsen Taylor Test (time frame: Jebsen Taylor Test used to assess gross manual dexterity before the intervention and after three months of the intervention . the loweest score indicate improvement). 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 28 Jan 2021.